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Partnership for Research on Ebola VACcinations (PREVAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02876328
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Results First Posted : September 28, 2022
Last Update Posted : December 8, 2023
Sponsor:
Collaborators:
Partnership for Research on Ebola Virus in Liberia (PREVAIL)
Institut National de la Santé Et de la Recherche Médicale, France
London School of Hygiene and Tropical Medicine
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Ebola Virus Disease
Interventions Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Biological: rVSVΔG-ZEBOV-GP
Biological: Placebo
Biological: rVSV boost
Enrollment 4789
Recruitment Details Healthy volunteers were enrolled at 6 sites in 4 countries: Guinea at 2 sites (Landreah and Maferinyah), Liberia (Redemption Hospital), Mali at 2 sites (Center for Vaccine Development and the University Clinical Research Center), and Sierra Leone (Mambolo). Total enrollment includes participants enrolled in all versions of the protocol, but only participants enrolled in version 4.0 of the protocol are included in the primary outcome analysis.
Pre-assignment Details 4789 participants were enrolled in the study, however, only 4786 participants are part of the data analysis.
Arm/Group Title Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Placebo (0.5 mL) - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Placebo (1 mL) - Adults (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Title: Placebo (0.5 mL) - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Placebo (1 mL) - Children (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Placebo (0.5 mL) - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Placebo (1 mL) - Adults (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Placebo (0.5 mL) - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Placebo (1 mL) - Children (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Placebo (0.5 mL) - Adults (v2.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Placebo (0.5 mL) - Children (v2.0)
Hide Arm/Group Description

Protocol Version 4.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm

rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 4.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh

rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 4.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 3.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm

rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 3.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh

rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 3.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 2.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm

Protocol Version 2.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 2.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 2.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
Period Title: Overall Study
Started 396 221 395 197 191 403 179 407 202 210 187 99 177 99 100 227 107 237 108 107 324 172 34 7
Completed [1] 379 208 378 188 181 388 175 395 192 202 182 98 172 95 96 223 102 227 106 105 312 164 33 7
Not Completed 17 13 17 9 10 15 4 12 10 8 5 1 5 4 4 4 5 10 2 2 12 8 1 0
Reason Not Completed
Death             2             1             3             0             0             0             1             3             0             1             1             0             0             0             0             0             1             1             0             0             0             1             0             0
Withdrawal by Subject             0             2             3             3             0             1             0             1             1             2             0             0             0             0             0             0             1             3             0             0             1             0             0             0
Missed 12 Month Visit             15             10             11             6             10             14             3             8             9             5             4             1             5             4             4             4             3             6             2             2             11             7             1             0
[1]
For the primary outcome, Completed is defined as attending the 12 month visit.
Arm/Group Title Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Placebo (0.5 mL) - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Placebo (1 mL) - Adults (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Placebo (0.5 mL) - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Placebo (1 mL) - Children (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Placebo (0.5 mL) - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Placebo (1 mL) - Adults (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Placebo (0.5 mL) - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Placebo (1 mL) - Children (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Placebo (0.5 mL) - Adults (v2.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Placebo (0.5 mL) - Children (v2.0) Total
Hide Arm/Group Description

Protocol Version 4.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm

rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 4.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh

rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 4.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm

rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 3.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh

rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 3.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 2.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm

Protocol Version 2.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 2.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 2.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh

 Total of all reporting groups
Overall Number of Baseline Participants 396 221 395 197 191 403 179 407 202 210 187 99 177 99 100 227 107 237 108 107 324 172 34 7 4786
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Adults Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 0 participants 0 participants 0 participants 0 participants 0 participants 187 participants 99 participants 177 participants 99 participants 100 participants 0 participants 0 participants 0 participants 0 participants 0 participants 324 participants 172 participants 0 participants 0 participants 2558 participants
27
(21 to 40)
28
(20 to 38)
27
(20 to 39)
26
(20 to 35)
26
(21 to 38)
30
(23 to 44)
31
(23 to 40)
29
(22 to 39)
28
(22 to 43)
28
(22 to 39)
27
(22 to 37)
27
(22 to 37)
27
(21 to 39)
Children Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 403 participants 179 participants 407 participants 202 participants 210 participants 0 participants 0 participants 0 participants 0 participants 0 participants 227 participants 107 participants 237 participants 108 participants 107 participants 0 participants 0 participants 34 participants 7 participants 2228 participants
8
(4 to 13)
8
(4 to 13)
9
(4 to 12)
8
(3 to 13)
8
(4 to 13)
12
(8 to 15)
12
(8 to 15)
12
(8 to 15)
12
(7 to 15)
12
(7 to 14)
14
(13 to 16)
14
(12 to 15)
10
(5 to 14)
[1]
Measure Analysis Population Description: Adults and children are analyzed separately.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
1-4 years Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 403 participants 179 participants 407 participants 202 participants 210 participants 187 participants 99 participants 177 participants 99 participants 100 participants 227 participants 107 participants 237 participants 108 participants 107 participants 324 participants 172 participants 34 participants 7 participants 4786 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
137
  34.0%
59
  33.0%
123
  30.2%
71
  35.1%
77
  36.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
25
  11.0%
12
  11.2%
24
  10.1%
9
   8.3%
12
  11.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
549
  11.5%
5-11 years Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 403 participants 179 participants 407 participants 202 participants 210 participants 187 participants 99 participants 177 participants 99 participants 100 participants 227 participants 107 participants 237 participants 108 participants 107 participants 324 participants 172 participants 34 participants 7 participants 4786 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
127
  31.5%
59
  33.0%
146
  35.9%
65
  32.2%
70
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
76
  33.5%
37
  34.6%
86
  36.3%
43
  39.8%
41
  38.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
750
  15.7%
12-17 years Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 403 participants 179 participants 407 participants 202 participants 210 participants 187 participants 99 participants 177 participants 99 participants 100 participants 227 participants 107 participants 237 participants 108 participants 107 participants 324 participants 172 participants 34 participants 7 participants 4786 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
139
  34.5%
61
  34.1%
138
  33.9%
66
  32.7%
63
  30.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
126
  55.5%
58
  54.2%
127
  53.6%
56
  51.9%
54
  50.5%
0
   0.0%
0
   0.0%
34
 100.0%
7
 100.0%
929
  19.4%
Adults >18 years Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 403 participants 179 participants 407 participants 202 participants 210 participants 187 participants 99 participants 177 participants 99 participants 100 participants 227 participants 107 participants 237 participants 108 participants 107 participants 324 participants 172 participants 34 participants 7 participants 4786 participants
396
 100.0%
221
 100.0%
395
 100.0%
197
 100.0%
191
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
187
 100.0%
99
 100.0%
177
 100.0%
99
 100.0%
100
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
324
 100.0%
172
 100.0%
0
   0.0%
0
   0.0%
2558
  53.4%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Adults Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 0 participants 0 participants 0 participants 0 participants 0 participants 187 participants 99 participants 177 participants 99 participants 100 participants 0 participants 0 participants 0 participants 0 participants 0 participants 324 participants 172 participants 0 participants 0 participants 2558 participants
Female
171
  43.2%
106
  48.0%
182
  46.1%
87
  44.2%
81
  42.4%
99
  52.9%
45
  45.5%
75
  42.4%
43
  43.4%
49
  49.0%
120
  37.0%
60
  34.9%
1118
  43.7%
Male
225
  56.8%
115
  52.0%
213
  53.9%
110
  55.8%
110
  57.6%
88
  47.1%
54
  54.5%
102
  57.6%
56
  56.6%
51
  51.0%
204
  63.0%
112
  65.1%
1440
  56.3%
Children Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 403 participants 179 participants 407 participants 202 participants 210 participants 0 participants 0 participants 0 participants 0 participants 0 participants 227 participants 107 participants 237 participants 108 participants 107 participants 0 participants 0 participants 34 participants 7 participants 2228 participants
Female
186
  46.2%
87
  48.6%
185
  45.5%
85
  42.1%
95
  45.2%
122
  53.7%
48
  44.9%
117
  49.4%
55
  50.9%
53
  49.5%
19
  55.9%
5
  71.4%
1057
  47.4%
Male
217
  53.8%
92
  51.4%
222
  54.5%
117
  57.9%
115
  54.8%
105
  46.3%
59
  55.1%
120
  50.6%
53
  49.1%
54
  50.5%
15
  44.1%
2
  28.6%
1171
  52.6%
[1]
Measure Analysis Population Description: Adults and children are analyzed separately.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Guinea Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 0 participants 0 participants 0 participants 0 participants 0 participants 187 participants 99 participants 177 participants 99 participants 100 participants 0 participants 0 participants 0 participants 0 participants 0 participants 324 participants 172 participants 0 participants 0 participants 2558 participants
121
  30.6%
72
  32.6%
130
  32.9%
66
  33.5%
63
  33.0%
144
  77.0%
80
  80.8%
141
  79.7%
77
  77.8%
76
  76.0%
158
  48.8%
84
  48.8%
1212
  47.4%
Liberia Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 0 participants 0 participants 0 participants 0 participants 0 participants 187 participants 99 participants 177 participants 99 participants 100 participants 0 participants 0 participants 0 participants 0 participants 0 participants 324 participants 172 participants 0 participants 0 participants 2558 participants
73
  18.4%
43
  19.5%
70
  17.7%
35
  17.8%
38
  19.9%
43
  23.0%
19
  19.2%
36
  20.3%
22
  22.2%
24
  24.0%
166
  51.2%
88
  51.2%
657
  25.7%
Mali Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 0 participants 0 participants 0 participants 0 participants 0 participants 187 participants 99 participants 177 participants 99 participants 100 participants 0 participants 0 participants 0 participants 0 participants 0 participants 324 participants 172 participants 0 participants 0 participants 2558 participants
81
  20.5%
48
  21.7%
84
  21.3%
41
  20.8%
38
  19.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
292
  11.4%
Sierra Leone Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 0 participants 0 participants 0 participants 0 participants 0 participants 187 participants 99 participants 177 participants 99 participants 100 participants 0 participants 0 participants 0 participants 0 participants 0 participants 324 participants 172 participants 0 participants 0 participants 2558 participants
121
  30.6%
58
  26.2%
111
  28.1%
55
  27.9%
52
  27.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
397
  15.5%
[1]
Measure Analysis Population Description: Adults and children are analyzed separately.
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Guinea Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 403 participants 179 participants 407 participants 202 participants 210 participants 0 participants 0 participants 0 participants 0 participants 0 participants 227 participants 107 participants 237 participants 108 participants 107 participants 0 participants 0 participants 34 participants 7 participants 2228 participants
163
  40.4%
71
  39.7%
156
  38.3%
77
  38.1%
79
  37.6%
160
  70.5%
72
  67.3%
163
  68.8%
76
  70.4%
77
  72.0%
17
  50.0%
4
  57.1%
1115
  50.0%
Liberia Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 403 participants 179 participants 407 participants 202 participants 210 participants 0 participants 0 participants 0 participants 0 participants 0 participants 227 participants 107 participants 237 participants 108 participants 107 participants 0 participants 0 participants 34 participants 7 participants 2228 participants
64
  15.9%
25
  14.0%
66
  16.2%
33
  16.3%
30
  14.3%
67
  29.5%
35
  32.7%
74
  31.2%
32
  29.6%
30
  28.0%
17
  50.0%
3
  42.9%
476
  21.4%
Mali Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 403 participants 179 participants 407 participants 202 participants 210 participants 0 participants 0 participants 0 participants 0 participants 0 participants 227 participants 107 participants 237 participants 108 participants 107 participants 0 participants 0 participants 34 participants 7 participants 2228 participants
95
  23.6%
40
  22.3%
94
  23.1%
46
  22.8%
51
  24.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
326
  14.6%
Sierra Leone Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 403 participants 179 participants 407 participants 202 participants 210 participants 0 participants 0 participants 0 participants 0 participants 0 participants 227 participants 107 participants 237 participants 108 participants 107 participants 0 participants 0 participants 34 participants 7 participants 2228 participants
81
  20.1%
43
  24.0%
91
  22.4%
46
  22.8%
50
  23.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
311
  14.0%
[1]
Measure Analysis Population Description: Adults and children are analyzed separately.
HIV Positive   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Adults Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 0 participants 0 participants 0 participants 0 participants 0 participants 187 participants 99 participants 177 participants 99 participants 100 participants 0 participants 0 participants 0 participants 0 participants 0 participants 324 participants 172 participants 0 participants 0 participants 2558 participants
6
   1.5%
1
   0.5%
13
   3.3%
2
   1.0%
3
   1.6%
5
   2.7%
2
   2.0%
4
   2.3%
2
   2.0%
2
   2.0%
6
   1.9%
8
   4.7%
54
   2.1%
Children Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 403 participants 179 participants 407 participants 202 participants 210 participants 0 participants 0 participants 0 participants 0 participants 0 participants 227 participants 107 participants 237 participants 108 participants 107 participants 0 participants 0 participants 34 participants 7 participants 2228 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Adults and children are analyzed separately. HIV positive minors were not included in the study.
Number of Participants with Results for Ebola IgG Concentration (Version 4)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Adults Number Analyzed 396 participants 221 participants 395 participants 197 participants 191 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1400 participants
394
  99.5%
220
  99.5%
388
  98.2%
197
 100.0%
189
  99.0%
1388
  99.1%
Children Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 403 participants 179 participants 407 participants 202 participants 210 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1401 participants
398
  98.8%
177
  98.9%
401
  98.5%
200
  99.0%
209
  99.5%
1385
  98.9%
[1]
Measure Analysis Population Description: The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Number of Participants with Ebola IgG Concentration < 66.96 EU/mL (Version 4)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Adults Number Analyzed 394 participants 220 participants 388 participants 197 participants 189 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1388 participants
142
  36.0%
78
  35.5%
144
  37.1%
66
  33.5%
68
  36.0%
498
  35.9%
Children Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 398 participants 177 participants 401 participants 200 participants 209 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1385 participants
198
  49.7%
87
  49.2%
187
  46.6%
97
  48.5%
101
  48.3%
670
  48.4%
[1]
Measure Description: 66.96 EU/mL is the lower limit of quantification for the Filovirus Animal Nonclinical Group (FANG) enzyme-linked immunosorbent assay (ELISA)
[2]
Measure Analysis Population Description: The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Number of Participants with Ebola IgG Concentration >= 200 EU/mL (Version 4.0)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Adults Number Analyzed 394 participants 220 participants 388 participants 197 participants 189 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1388 participants
50
  12.7%
38
  17.3%
58
  14.9%
32
  16.2%
30
  15.9%
208
  15.0%
Children Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 398 participants 177 participants 401 participants 200 participants 209 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1385 participants
43
  10.8%
22
  12.4%
47
  11.7%
19
   9.5%
32
  15.3%
163
  11.8%
[1]
Measure Analysis Population Description: The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Median Ebola IgG Concentration (Version 4.0)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  EU/mL
Adults Number Analyzed 394 participants 220 participants 388 participants 197 participants 189 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1388 participants
94
(43 to 149)
99
(49 to 158)
92
(45 to 145)
94
(46 to 143)
94
(47 to 149)
95
(46 to 148)
Children Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 398 participants 177 participants 401 participants 200 participants 209 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1385 participants
67
(29 to 127)
68
(33 to 114)
74
(33 to 122)
69
(33 to 122)
78
(33 to 151)
70
(32 to 128)
[1]
Measure Analysis Population Description: The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Geometric Mean Ebola IgG Concentration (Version 4.0)   [1] 
Geometric Mean (Standard Deviation)
Unit of measure:  EU/mL
Adults Number Analyzed 394 participants 220 participants 388 participants 197 participants 189 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1388 participants
85  (2.7) 92  (2.8) 87  (2.7) 91  (2.7) 87  (2.8) 88  (2.7)
Children Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 398 participants 177 participants 401 participants 200 participants 209 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1385 participants
63  (3.0) 66  (2.8) 67  (3.0) 67  (3.1) 73  (3.1) 66  (3.0)
[1]
Measure Analysis Population Description: The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
1.Primary Outcome
Title Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response
Hide Description Antibody responder at 12 months is defined as a participant who experiences a 4-fold increase in antibody level from baseline and for whom the antibody level at 12 months is greater than or equal to 200 EU/mL.
Time Frame Measured through Month 12
Hide Outcome Measure Data
Hide Analysis Population Description

The analysis population only includes participants from version 4.0 of the protocol. Adults and children are analyzed separately.

Participants with a missing baseline or 12-month antibody result are excluded. Participants with elevated antibody levels at baseline were not excluded. The placebo group is pooled. Percentages of participants that do not yield whole numbers are the result of rounding.
Arm/Group Title Protocol Version 4.0 Ad26/MVA Protocol Version 4.0 rVSV Protocol Version 4.0 rVSV Boost Protocol Version 4.0 Pooled Placebo
Hide Arm/Group Description:
Ad26.ZEBOV first dose (0.5 mL) followed by an MVA-BN-Filo second dose (0.5 mL) at 56 days
rVSVΔG-ZEBOV-GP first dose (1 mL) followed by placebo second dose (1 mL) at 56 days
rVSVΔG-ZEBOV-GP first dose(1 mL) followed by an rVSVΔG-ZEBOV-GP dose (1 mL) at 56 days
Placebo dose (0.5 mL or 1 mL) followed by a placebo second dose (0.5 mL or 1 mL) at 56 days
Overall Number of Participants Analyzed 755 756 374 741
Measure Type: Number
Unit of Measure: percentage of participants
Adults Number Analyzed 374 participants 371 participants 185 participants 377 participants
40.9 75.7 81.1 2.7
Children Number Analyzed 381 participants 385 participants 189 participants 364 participants
78.5 87.3 92.6 3.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Protocol Version 4.0 Ad26/MVA, Protocol Version 4.0 rVSV, Protocol Version 4.0 rVSV Boost, Protocol Version 4.0 Pooled Placebo
Comments Analysis applies to both adults and children.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Each active group is compared to placebo using a 2-sided .0167 significance level.
Method Cochran-Mantel-Haenszel
Comments Analyses are stratified by site.
2.Secondary Outcome
Title Frequency of Serious Adverse Events (SAEs)
Hide Description SAEs as defined in the protocol
Time Frame Measured through Month 60
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response
Hide Description Antibodies to the Ebola virus glycoprotein will be measured with the Filovirus Animal Nonclinical Group (FANG) ELISA assay if available. Other assays may also be used.
Time Frame Measured through Month 60
Outcome Measure Data Not Reported
Time Frame 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete.
Adverse Event Reporting Description

AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected.

Systematically assessed AEs were collected via standard checklist.
 
Arm/Group Title Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Pooled Placebo (0.5 mL or 1 mL) - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Pooled Placebo (0.5 mL or 1 mL) - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Pooled Placebo (0.5 mL or 1 mL) - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Pooled Placebo (0.5 mL or 1 mL) - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Placebo (0.5 mL) - Adults (v2.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Placebo (0.5 mL) - Children (v2.0)
Hide Arm/Group Description

Protocol Version 4.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm

rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 4.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 4.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh

rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh

Protocol Version 3.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm

rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm

Protocol Version 3.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 3.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh

Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 3.0

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh

rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 2.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm

Protocol Version 2.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm

Protocol Version 2.0

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh

MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh

Protocol Version 2.0

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
All-Cause Mortality
Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Pooled Placebo (0.5 mL or 1 mL) - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Pooled Placebo (0.5 mL or 1 mL) - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Pooled Placebo (0.5 mL or 1 mL) - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Pooled Placebo (0.5 mL or 1 mL) - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Placebo (0.5 mL) - Adults (v2.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Placebo (0.5 mL) - Children (v2.0)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/396 (0.51%)      1/412 (0.24%)      3/395 (0.76%)      0/197 (0.00%)      0/403 (0.00%)      2/389 (0.51%)      3/407 (0.74%)      0/202 (0.00%)      1/187 (0.53%)      0/199 (0.00%)      0/177 (0.00%)      0/99 (0.00%)      0/227 (0.00%)      1/214 (0.47%)      1/237 (0.42%)      0/108 (0.00%)      0/324 (0.00%)      1/172 (0.58%)      0/34 (0.00%)      0/7 (0.00%)    
Hide Serious Adverse Events
Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Pooled Placebo (0.5 mL or 1 mL) - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Pooled Placebo (0.5 mL or 1 mL) - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Pooled Placebo (0.5 mL or 1 mL) - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Pooled Placebo (0.5 mL or 1 mL) - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Placebo (0.5 mL) - Adults (v2.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Placebo (0.5 mL) - Children (v2.0)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/396 (3.54%)      5/412 (1.21%)      6/395 (1.52%)      1/197 (0.51%)      5/403 (1.24%)      8/389 (2.06%)      9/407 (2.21%)      3/202 (1.49%)      12/187 (6.42%)      6/199 (3.02%)      6/177 (3.39%)      2/99 (2.02%)      4/227 (1.76%)      7/214 (3.27%)      6/237 (2.53%)      1/108 (0.93%)      6/324 (1.85%)      5/172 (2.91%)      1/34 (2.94%)      0/7 (0.00%)    
Blood and lymphatic system disorders                                         
ANAEMIA * 1  0/396 (0.00%)  0 1/412 (0.24%)  1 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
SICKLE CELL ANAEMIA WITH CRISIS * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 1/389 (0.26%)  1 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
Eye disorders                                         
BLINDNESS UNILATERAL * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 1/202 (0.50%)  1 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
Gastrointestinal disorders                                         
ABDOMINAL HERNIA * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 1/199 (0.50%)  1 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
ABDOMINAL PAIN LOWER * 1  1/396 (0.25%)  1 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
ABDOMINAL PAIN UPPER * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 1/395 (0.25%)  1 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
ACUTE ABDOMEN * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 1/197 (0.51%)  1 0/403 (0.00%)  0 0/389 (0.00%)  0 1/407 (0.25%)  1 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 1/227 (0.44%)  1 0/214 (0.00%)  0 1/237 (0.42%)  1 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
DIARRHOEA * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 1/172 (0.58%)  1 0/34 (0.00%)  0 0/7 (0.00%)  0
GASTROINTESTINAL OBSTRUCTION * 1  1/396 (0.25%)  1 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
INGUINAL HERNIA * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 1/187 (0.53%)  1 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 1/172 (0.58%)  1 0/34 (0.00%)  0 0/7 (0.00%)  0
INGUINAL HERNIA; INGUINAL HERNIA * 1 [1]  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 1/324 (0.31%)  1 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
INGUINAL HERNIA, OBSTRUCTIVE; INGUINAL HERNIA * 1  1/396 (0.25%)  1 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
PERITONEAL HAEMORRHAGE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 1/407 (0.25%)  1 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
General disorders                                         
test * 1  1/396 (0.25%)  0/412 (0.00%)  0/395 (0.00%)  0/197 (0.00%)  0/403 (0.00%)  0/389 (0.00%)  0/407 (0.00%)  0/202 (0.00%)  0/187 (0.00%)  0/199 (0.00%)  0/177 (0.00%)  0/99 (0.00%)  0/227 (0.00%)  0/214 (0.00%)  0/237 (0.00%)  0/108 (0.00%)  0/324 (0.00%)  0/172 (0.00%)  0/34 (0.00%)  0/7 (0.00%) 
ANAEMIA; MALARIA * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 1/202 (0.50%)  1 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
APPENDICITIS; VAGINAL DISCHARGE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 1/237 (0.42%)  1 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
COMPARTMENT SYNDROME; HUMERUS FRACTURE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 1/99 (1.01%)  1 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
DEATH * 1  1/396 (0.25%)  1 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 1/389 (0.26%)  1 2/407 (0.49%)  2 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
DIABETES MELLITUS; URINARY TRACT INFECTION * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 1/177 (0.56%)  1 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
DROWNING * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 1/407 (0.25%)  1 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 1/214 (0.47%)  1 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
GENITAL HAEMORRHAGE; UTERINE CONTRACTIONS DURING PREGNANCY * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 1/227 (0.44%)  1 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
HYPERTENSION; DIABETES MELLITUS INADEQUATE CONTROL; KETOACIDOSIS * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 1/177 (0.56%)  1 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
MALARIA; ACUTE ABDOMEN; ANAEMIA OF PREGNANCY * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 1/214 (0.47%)  1 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
PERITONITIS; GASTRIC PERFORATION * 1  1/396 (0.25%)  1 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
PYREXIA * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 1/407 (0.25%)  1 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
SUBILEUS; MALNUTRITION; FURUNCLE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 1/403 (0.25%)  1 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
UTERINE CONTRACTIONS DURING PREGNANCY; ABDOMINAL PAIN; PELVIC PAIN * 1  1/396 (0.25%)  1 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
Immune system disorders                                         
ANAPHYLACTIC REACTION * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 1/324 (0.31%)  1 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
Infections and infestations                                         
ABSCESS LIMB * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 1/324 (0.31%)  1 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
APPENDICITIS * 1  6/396 (1.52%)  6 2/412 (0.49%)  2 1/395 (0.25%)  1 0/197 (0.00%)  0 1/403 (0.25%)  1 2/389 (0.51%)  2 1/407 (0.25%)  1 0/202 (0.00%)  0 1/187 (0.53%)  1 0/199 (0.00%)  0 2/177 (1.13%)  2 0/99 (0.00%)  0 1/227 (0.44%)  1 2/214 (0.93%)  2 1/237 (0.42%)  1 1/108 (0.93%)  1 1/324 (0.31%)  1 0/172 (0.00%)  0 1/34 (2.94%)  1 0/7 (0.00%)  0
CELLULITIS * 1  0/396 (0.00%)  0 1/412 (0.24%)  1 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
GASTROENTERITIS * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 1/199 (0.50%)  1 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
HIV INFECTION * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 1/395 (0.25%)  1 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
MALARIA * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 1/403 (0.25%)  1 1/389 (0.26%)  1 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 1/237 (0.42%)  1 0/108 (0.00%)  0 1/324 (0.31%)  1 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
MALARIA; GENITAL INFECTION; APPENDICITIS * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 1/199 (0.50%)  1 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
PERITONITIS * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 1/395 (0.25%)  1 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
PNEUMONIA * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 1/389 (0.26%)  1 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
PULMONARY TUBERCULOSIS * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 1/395 (0.25%)  1 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
SALMONELLOSIS; SALPINGITIS; PYELONEPHRITIS * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 1/187 (0.53%)  1 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
SEPSIS * 1  1/396 (0.25%)  1 0/412 (0.00%)  0 1/395 (0.25%)  1 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
TYPHOID FEVER * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 1/407 (0.25%)  1 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
WOUND INFECTION * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 1/403 (0.25%)  1 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
Injury, poisoning and procedural complications                                         
ANKLE FRACTURE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 1/187 (0.53%)  1 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
BURNS FIRST DEGREE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 1/227 (0.44%)  1 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
BURNS SECOND DEGREE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 1/187 (0.53%)  1 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
CLAVICLE FRACTURE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 1/389 (0.26%)  1 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
EYE INJURY * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 1/202 (0.50%)  1 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
FRACTURE; TIBIA FRACTURE; FIBULA FRACTURE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 1/403 (0.25%)  1 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
HEAD INJURY * 1  0/396 (0.00%)  0 1/412 (0.24%)  1 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
HEAD INJURY; JAW FRACTURE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 1/177 (0.56%)  1 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
HUMERUS FRACTURE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 1/395 (0.25%)  1 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
LIMB INJURY; WOUND SECRETION * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 1/187 (0.53%)  1 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
LOWER LIMB FRACTURE * 1  1/396 (0.25%)  1 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
RADIUS FRACTURE * 1  1/396 (0.25%)  1 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 1/202 (0.50%)  1 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
RADIUS FRACTURE; ULNA FRACTURE * 1  1/396 (0.25%)  1 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
ROAD TRAFFIC ACCIDENT * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 1/187 (0.53%)  1 1/199 (0.50%)  1 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
SNAKE BITE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 1/214 (0.47%)  1 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
VENOM POISONING * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 1/389 (0.26%)  1 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
WRIST FRACTURE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 1/237 (0.42%)  1 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
Metabolism and nutrition disorders                                         
DIABETES MELLITUS * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 1/172 (0.58%)  1 0/34 (0.00%)  0 0/7 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                                         
UTERINE LEIOMYOMA * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 1/187 (0.53%)  1 0/199 (0.00%)  0 0/177 (0.00%)  0 1/99 (1.01%)  1 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders                                         
CEREBROVASCULAR ACCIDENT * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 1/187 (0.53%)  1 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 1/172 (0.58%)  1 0/34 (0.00%)  0 0/7 (0.00%)  0
ISCHAEMIC STROKE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 1/187 (0.53%)  1 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
Pregnancy, puerperium and perinatal conditions                                         
ABORTION INCOMPLETE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 1/407 (0.25%)  1 0/202 (0.00%)  0 1/187 (0.53%)  1 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
ABORTION SPONTANEOUS * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 1/187 (0.53%)  1 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
ABORTION SPONTANEOUS INCOMPLETE * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 1/199 (0.50%)  1 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
ECTOPIC PREGNANCY * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 1/395 (0.25%)  1 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
OBSTRUCTED LABOUR * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 1/214 (0.47%)  1 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
PREMATURE SEPARATION OF PLACENTA * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 1/324 (0.31%)  1 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
Reproductive system and breast disorders                                         
METRORRHAGIA * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 1/177 (0.56%)  1 0/99 (0.00%)  0 0/227 (0.00%)  0 1/214 (0.47%)  1 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                                         
ASTHMA * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 1/199 (0.50%)  1 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
ASTHMATIC CRISIS * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 1/237 (0.42%)  1 0/108 (0.00%)  0 0/324 (0.00%)  0 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders                                         
PRURITUS GENERALISED * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 1/324 (0.31%)  1 0/172 (0.00%)  0 0/34 (0.00%)  0 0/7 (0.00%)  0
SKIN ULCER * 1  0/396 (0.00%)  0 0/412 (0.00%)  0 0/395 (0.00%)  0 0/197 (0.00%)  0 0/403 (0.00%)  0 0/389 (0.00%)  0 0/407 (0.00%)  0 0/202 (0.00%)  0 0/187 (0.00%)  0 0/199 (0.00%)  0 0/177 (0.00%)  0 0/99 (0.00%)  0 0/227 (0.00%)  0 0/214 (0.00%)  0 0/237 (0.00%)  0 0/108 (0.00%)  0 0/324 (0.00%)  0 1/172 (0.58%)  1 0/34 (0.00%)  0 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA (22.0)
*
Indicates events were collected by non-systematic assessment
[1]
Bilateral inguinal hernia and Scrotal hernia (LLT)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Pooled Placebo (0.5 mL or 1 mL) - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Pooled Placebo (0.5 mL or 1 mL) - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Pooled Placebo (0.5 mL or 1 mL) - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Pooled Placebo (0.5 mL or 1 mL) - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Placebo (0.5 mL) - Adults (v2.0) Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Placebo (0.5 mL) - Children (v2.0)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   296/396 (74.75%)      291/412 (70.63%)      320/395 (81.01%)      155/197 (78.68%)      341/403 (84.62%)      298/389 (76.61%)      350/407 (86.00%)      179/202 (88.61%)      142/187 (75.94%)      151/199 (75.88%)      148/177 (83.62%)      80/99 (80.81%)      167/227 (73.57%)      143/214 (66.82%)      186/237 (78.48%)      84/108 (77.78%)      232/324 (71.60%)      97/172 (56.40%)      23/34 (67.65%)      4/7 (57.14%)    
Gastrointestinal disorders                                         
Abdominal pain † 1  70/396 (17.68%)  88 77/412 (18.69%)  99 80/395 (20.25%)  107 39/197 (19.80%)  52 92/403 (22.83%)  169 69/389 (17.74%)  127 97/407 (23.83%)  184 44/202 (21.78%)  95 41/187 (21.93%)  57 36/199 (18.09%)  49 38/177 (21.47%)  47 17/99 (17.17%)  27 53/227 (23.35%)  90 48/214 (22.43%)  88 56/237 (23.63%)  102 24/108 (22.22%)  35 43/324 (13.27%)  60 23/172 (13.37%)  30 7/34 (20.59%)  9 1/7 (14.29%)  2
Diarrhoea † 1  12/396 (3.03%)  12 19/412 (4.61%)  20 19/395 (4.81%)  21 7/197 (3.55%)  11 22/403 (5.46%)  40 40/389 (10.28%)  56 30/407 (7.37%)  39 21/202 (10.40%)  28 11/187 (5.88%)  11 9/199 (4.52%)  12 8/177 (4.52%)  8 3/99 (3.03%)  4 8/227 (3.52%)  12 18/214 (8.41%)  25 17/237 (7.17%)  22 5/108 (4.63%)  7 9/324 (2.78%)  12 5/172 (2.91%)  6 2/34 (5.88%)  3 0/7 (0.00%)  0
Mouth ulceration † 1  4/396 (1.01%)  4 7/412 (1.70%)  8 12/395 (3.04%)  14 3/197 (1.52%)  3 7/403 (1.74%)  15 10/389 (2.57%)  13 7/407 (1.72%)  11 9/202 (4.46%)  21 8/187 (4.28%)  8 11/199 (5.53%)  11 7/177 (3.95%)  7 6/99 (6.06%)  7 5/227 (2.20%)  6 9/214 (4.21%)  11 10/237 (4.22%)  13 3/108 (2.78%)  8 11/324 (3.40%)  11 2/172 (1.16%)  2 0/34 (0.00%)  0 0/7 (0.00%)  0
Nausea † 1  27/396 (6.82%)  31 37/412 (8.98%)  46 51/395 (12.91%)  61 22/197 (11.17%)  29 26/403 (6.45%)  42 26/389 (6.68%)  37 39/407 (9.58%)  61 11/202 (5.45%)  15 19/187 (10.16%)  23 16/199 (8.04%)  20 19/177 (10.73%)  26 11/99 (11.11%)  14 19/227 (8.37%)  26 11/214 (5.14%)  17 13/237 (5.49%)  16 10/108 (9.26%)  15 19/324 (5.86%)  23 18/172 (10.47%)  24 3/34 (8.82%)  3 1/7 (14.29%)  1
Vomiting † 1  15/396 (3.79%)  16 16/412 (3.88%)  16 25/395 (6.33%)  28 12/197 (6.09%)  13 52/403 (12.90%)  70 39/389 (10.03%)  53 55/407 (13.51%)  77 24/202 (11.88%)  38 1/187 (0.53%)  1 9/199 (4.52%)  11 6/177 (3.39%)  6 2/99 (2.02%)  2 20/227 (8.81%)  27 15/214 (7.01%)  21 19/237 (8.02%)  29 12/108 (11.11%)  14 2/324 (0.62%)  2 5/172 (2.91%)  5 0/34 (0.00%)  0 0/7 (0.00%)  0
General disorders                                         
Chills † 1  51/396 (12.88%)  55 48/412 (11.65%)  57 81/395 (20.51%)  97 37/197 (18.78%)  42 72/403 (17.87%)  114 59/389 (15.17%)  85 80/407 (19.66%)  128 34/202 (16.83%)  48 21/187 (11.23%)  24 21/199 (10.55%)  25 31/177 (17.51%)  40 14/99 (14.14%)  17 37/227 (16.30%)  50 21/214 (9.81%)  32 36/237 (15.19%)  52 12/108 (11.11%)  17 40/324 (12.35%)  45 16/172 (9.30%)  17 3/34 (8.82%)  3 2/7 (28.57%)  3
Crying † 1 [1]  0/0  0 0/0  0 0/0  0 0/0  0 26/137 (18.98%)  39 15/136 (11.03%)  28 27/123 (21.95%)  48 14/71 (19.72%)  26 0/0  0 0/0  0 0/0  0 0/0  0 1/25 (4.00%)  5 1/24 (4.17%)  1 5/24 (20.83%)  5 1/9 (11.11%)  1 0/0  0 0/0  0 0/0  0 0/0  0
Fatigue † 1  91/396 (22.98%)  119 84/412 (20.39%)  106 113/395 (28.61%)  151 61/197 (30.96%)  86 82/403 (20.35%)  131 66/389 (16.97%)  110 111/407 (27.27%)  186 44/202 (21.78%)  73 67/187 (35.83%)  107 69/199 (34.67%)  100 74/177 (41.81%)  106 37/99 (37.37%)  57 55/227 (24.23%)  96 25/214 (11.68%)  34 60/237 (25.32%)  100 31/108 (28.70%)  55 68/324 (20.99%)  115 39/172 (22.67%)  57 5/34 (14.71%)  9 2/7 (28.57%)  5
Pyrexia † 1  156/396 (39.39%)  204 135/412 (32.77%)  188 180/395 (45.57%)  241 87/197 (44.16%)  130 261/403 (64.76%)  534 192/389 (49.36%)  399 278/407 (68.30%)  620 145/202 (71.78%)  314 55/187 (29.41%)  79 52/199 (26.13%)  82 69/177 (38.98%)  97 34/99 (34.34%)  43 88/227 (38.77%)  161 68/214 (31.78%)  101 114/237 (48.10%)  207 45/108 (41.67%)  84 66/324 (20.37%)  79 24/172 (13.95%)  27 8/34 (23.53%)  11 1/7 (14.29%)  1
Metabolism and nutrition disorders                                         
Decreased appetite † 1  55/396 (13.89%)  69 54/412 (13.11%)  61 77/395 (19.49%)  98 32/197 (16.24%)  41 94/403 (23.33%)  162 80/389 (20.57%)  127 120/407 (29.48%)  220 59/202 (29.21%)  118 37/187 (19.79%)  58 39/199 (19.60%)  55 53/177 (29.94%)  73 24/99 (24.24%)  29 52/227 (22.91%)  82 31/214 (14.49%)  48 58/237 (24.47%)  110 26/108 (24.07%)  41 47/324 (14.51%)  58 21/172 (12.21%)  27 6/34 (17.65%)  12 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders                                         
Arthralgia † 1  79/396 (19.95%)  109 63/412 (15.29%)  82 94/395 (23.80%)  128 45/197 (22.84%)  64 28/403 (6.95%)  41 18/389 (4.63%)  29 38/407 (9.34%)  61 14/202 (6.93%)  21 52/187 (27.81%)  78 48/199 (24.12%)  70 57/177 (32.20%)  84 29/99 (29.29%)  42 24/227 (10.57%)  32 15/214 (7.01%)  19 31/237 (13.08%)  51 12/108 (11.11%)  21 66/324 (20.37%)  99 22/172 (12.79%)  31 4/34 (11.76%)  10 0/7 (0.00%)  0
Myalgia † 1  105/396 (26.52%)  142 92/412 (22.33%)  115 138/395 (34.94%)  188 68/197 (34.52%)  92 62/403 (15.38%)  93 38/389 (9.77%)  46 78/407 (19.16%)  112 32/202 (15.84%)  51 56/187 (29.95%)  79 54/199 (27.14%)  72 61/177 (34.46%)  79 33/99 (33.33%)  40 34/227 (14.98%)  42 24/214 (11.21%)  28 50/237 (21.10%)  68 25/108 (23.15%)  36 76/324 (23.46%)  86 23/172 (13.37%)  24 6/34 (17.65%)  11 1/7 (14.29%)  1
Nervous system disorders                                         
Dizziness † 1  44/396 (11.11%)  53 46/412 (11.17%)  52 60/395 (15.19%)  67 15/197 (7.61%)  18 38/403 (9.43%)  70 27/389 (6.94%)  49 55/407 (13.51%)  96 19/202 (9.41%)  33 26/187 (13.90%)  35 35/199 (17.59%)  49 33/177 (18.64%)  45 16/99 (16.16%)  22 9/227 (3.96%)  15 17/214 (7.94%)  22 21/237 (8.86%)  29 9/108 (8.33%)  16 38/324 (11.73%)  45 17/172 (9.88%)  22 2/34 (5.88%)  3 2/7 (28.57%)  3
Headache † 1  215/396 (54.29%)  376 218/412 (52.91%)  398 250/395 (63.29%)  447 116/197 (58.88%)  203 169/403 (41.94%)  438 150/389 (38.56%)  375 217/407 (53.32%)  555 97/202 (48.02%)  245 110/187 (58.82%)  212 114/199 (57.29%)  209 114/177 (64.41%)  214 66/99 (66.67%)  116 103/227 (45.37%)  220 93/214 (43.46%)  173 124/237 (52.32%)  264 56/108 (51.85%)  138 163/324 (50.31%)  264 71/172 (41.28%)  115 17/34 (50.00%)  30 2/7 (28.57%)  5
Skin and subcutaneous tissue disorders                                         
Hyperhidrosis † 1  7/396 (1.77%)  7 6/412 (1.46%)  6 7/395 (1.77%)  9 6/197 (3.05%)  7 13/403 (3.23%)  22 11/389 (2.83%)  15 15/407 (3.69%)  22 3/202 (1.49%)  3 4/187 (2.14%)  4 5/199 (2.51%)  5 8/177 (4.52%)  8 2/99 (2.02%)  2 4/227 (1.76%)  6 5/214 (2.34%)  5 9/237 (3.80%)  12 5/108 (4.63%)  6 11/324 (3.40%)  12 7/172 (4.07%)  11 0/34 (0.00%)  0 1/7 (14.29%)  1
Skin lesion † 1  18/396 (4.55%)  22 17/412 (4.13%)  23 18/395 (4.56%)  21 9/197 (4.57%)  10 40/403 (9.93%)  60 41/389 (10.54%)  64 37/407 (9.09%)  58 15/202 (7.43%)  26 23/187 (12.30%)  25 14/199 (7.04%)  22 21/177 (11.86%)  27 6/99 (6.06%)  6 24/227 (10.57%)  40 18/214 (8.41%)  25 23/237 (9.70%)  33 12/108 (11.11%)  18 17/324 (5.25%)  20 10/172 (5.81%)  11 1/34 (2.94%)  1 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA (22.0)
†
Indicates events were collected by systematic assessment
[1]
Only potentially non-verbal children less than 5 years of age assessed.
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Tierney, Director of Office of the Clinical Research Policy and Regulatory Operations (OCRPRO)
Organization: National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 301.451.5136
EMail: JTierney@niaid.nih.gov
Publications of Results:
Badio M, Lhomme E, Kieh M, Beavogui AH, Kennedy SB, Doumbia S, Leigh B, Sow SO, Diallo A, Fusco D, Kirchoff M, Termote M, Vatrinet R, Wentworth D, Esperou H, Lane HC, Pierson J, Watson-Jones D, Roy C, D'Ortenzio E, Greenwood B, Chene G, Richert L, Neaton JD, Yazdanpanah Y; PREVAC study team. Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries. Trials. 2021 Jan 23;22(1):86. doi: 10.1186/s13063-021-05035-9. Erratum In: Trials. 2021 Sep 1;22(1):583.
PREVAC Study Team; Kieh M, Richert L, Beavogui AH, Grund B, Leigh B, D'Ortenzio E, Doumbia S, Lhomme E, Sow S, Vatrinet R, Roy C, Kennedy SB, Faye S, Lees S, Millimouno NP, Camara AM, Samai M, Deen GF, Doumbia M, Esperou H, Pierson J, Watson-Jones D, Diallo A, Wentworth D, McLean C, Simon J, Wiedemann A, Dighero-Kemp B, Hensley L, Lane HC, Levy Y, Piot P, Greenwood B, Chene G, Neaton J, Yazdanpanah Y. Randomized Trial of Vaccines for Zaire Ebola Virus Disease. N Engl J Med. 2022 Dec 29;387(26):2411-2424. doi: 10.1056/NEJMoa2200072. Epub 2022 Dec 14.
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02876328    
Other Study ID Numbers: C15-33
PREVACEBL3005 ( Other Identifier: LSHTM )
First Submitted: August 16, 2016
First Posted: August 23, 2016
Results First Submitted: July 14, 2022
Results First Posted: September 28, 2022
Last Update Posted: December 8, 2023