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A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine

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: NCT03554798
Recruitment Status : Completed
First Posted : June 13, 2018
Results First Posted : March 23, 2022
Last Update Posted : January 19, 2024
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Fidec Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Poliomyelitis
Intervention Biological: nOPV2 (monovalent oral polio vaccine)
Enrollment 1025
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1+L2 [2018] Stage II - Group B2H1+H2[2018]
Hide Arm/Group Description 50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]). 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days. 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days. 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later. 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later. 162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018). 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later. 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
Period Title: Overall Study
Started 50 50 51 156 144 138 150 135 151
Completed 45 47 48 154 141 137 149 133 149
Not Completed 5 3 3 2 3 1 1 2 2
Arm/Group Title Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1 +L2[2018] Stage II - Group B2H1+H2[2018] Total
Hide Arm/Group Description 50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]). 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days. 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days. 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1[2016] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later. 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later. 162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later. 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later. Total of all reporting groups
Overall Number of Baseline Participants 50 49 51 156 144 138 150 135 151 1024
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 51 participants 156 participants 144 participants 138 participants 150 participants 135 participants 151 participants 1024 participants
<=18 years
50
 100.0%
49
 100.0%
51
 100.0%
156
 100.0%
144
 100.0%
138
 100.0%
150
 100.0%
135
 100.0%
151
 100.0%
1024
 100.0%
Between 18 and 65 years
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%
>=65 years
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%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 51 participants 156 participants 144 participants 138 participants 150 participants 135 participants 151 participants 1024 participants
Female
17
  34.0%
24
  49.0%
29
  56.9%
66
  42.3%
65
  45.1%
69
  50.0%
71
  47.3%
74
  54.8%
73
  48.3%
488
  47.7%
Male
33
  66.0%
25
  51.0%
22
  43.1%
90
  57.7%
79
  54.9%
69
  50.0%
79
  52.7%
61
  45.2%
78
  51.7%
536
  52.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 50 participants 49 participants 51 participants 156 participants 144 participants 138 participants 150 participants 135 participants 151 participants 1024 participants
Mixed race
24
  48.0%
49
 100.0%
51
 100.0%
151
  96.8%
141
  97.9%
135
  97.8%
147
  98.0%
132
  97.8%
151
 100.0%
981
  95.8%
Other
26
  52.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
26
   2.5%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
3
   1.9%
0
   0.0%
0
   0.0%
1
   0.7%
1
   0.7%
0
   0.0%
5
   0.5%
Central American Indian
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
2
   1.4%
3
   2.2%
2
   1.3%
1
   0.7%
0
   0.0%
9
   0.9%
Hispanic
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.1%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
1
   0.7%
0
   0.0%
2
   0.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Panama Number Analyzed 50 participants 49 participants 51 participants 156 participants 144 participants 138 participants 150 participants 135 participants 151 participants 1024 participants
50 49 51 156 144 138 150 135 151 1024
1.Primary Outcome
Title Serious Adverse Reactions (SARs), Severe AEs and Important Medical Reactions (IMRs) Incidence
Hide Description Number of subjects experiencing Serious Adverse Reactions (SAR), severe AR and IMR, i.e. SAEs, severe AEs (grade 3), or IMEs considered consistent with a causal association with study vaccines as of the informed consent signature date and throughout the study period in all groups.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety parameters were tabulated and analyzed descriptively in the total vaccinated (TV) population, according to the actual vaccine received. TV population is defined as all subjects who received at least one dose of study vaccine.
Arm/Group Title Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1 +L2[2018] Stage II - Group B2H1+H2[2018]
Hide Arm/Group Description:
50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]).
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1[2016] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
Overall Number of Participants Analyzed 50 49 51 155 144 138 150 135 151
Measure Type: Number
Unit of Measure: participants
0 1 0 5 6 1 1 1 1
2.Primary Outcome
Title Single Dose Seroprotection Rate
Hide Description Seroprotection rate of type 2 polio neutralizing antibodies at Day 28 following a single 105 or 106 CCID50 dose of nOPV2 candidates in all groups. Seroprotection rate is defined as the percentage of subjects with type 2-specific antibody titers ≥ 1:8 per group.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1+L2 [2018] Stage II - Group B2H1+H2[2018]
Hide Arm/Group Description:
50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]).
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
Overall Number of Participants Analyzed 45 37 47 145 136 131 143 127 146
Measure Type: Count of Participants
Unit of Measure: Participants
45
 100.0%
37
 100.0%
47
 100.0%
125
  86.2%
132
  97.1%
122
  93.1%
134
  93.7%
115
  90.6%
138
  94.5%
3.Secondary Outcome
Title Any Other SAEs, AEs and IMEs Incidence
Hide Description Number of participants experiencing any other SAE, any solicited AE, any unsolicited AEs and any IME as well as any clinical laboratory deviation considered consistent with causal association to study vaccine (primary objective) following one or two doses of either nOPV2 candidates.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

Assessed in total vaccinated (TV) population, defined as all subjects who received at least one dose of study vaccine.Only secondary objectives included intent to compare the M5 data with the control sample which had received Sabin mOPV2 in M2 study (NCT02521974-historical control for M5).

Extent of exposure: in M5 Stage II, the second dose of study vaccine were received by 47 (94%) children in Group A1H2[2018] and 50 (98%) children in Group A2H2[2018].
Arm/Group Title Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1+L2 [2018] Stage II - Group B2H1+H2[2018] M2 Group 2+3 M2 Children
Hide Arm/Group Description:
50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]).
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
114 infants (3 bOPV/1 IPV primed) were to receive at 18 weeks of age one dose of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 2). A randomly selected sub-group of 50 infants were to receive a second dose of Sabin mOPV2 approximately 28 days later (Group 3).
50 IPV and/or OPV vaccinated children aged 1 to <5 years were to receive 2 doses of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 1), separated by 28 days
Overall Number of Participants Analyzed 50 49 51 155 144 138 150 135 151 110 50
Measure Type: Number
Unit of Measure: participants
SAEs 0 1 2 2 0 9 1 3 5 0 1
IMEs 1 0 0 0 0 0 0 0 0 1 0
AEs 32 36 44 30 29 34 37 36 33 36 28
4.Secondary Outcome
Title Seroconversion Rates Comparison
Hide Description Seroconversion rates against type 2 of one or two 106 CCID50 doses of both nOPV2 vaccine candidates in healthy children aged 1 to 5 years and of two doses of both nOPV2 vaccine candidates at both 105 and 106 CCID50 dose levels at approximately 22 weeks of age in infants previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this immunogenicity with a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study (M2) designed and performed to serve as a control for the current study. Seroconversion is defined as a change from seronegative to seropositive, and in seropositive subjects, as an antibody titer increase of ≥ 4 fold over baseline (Day 0) titers corrected for maternal antibodies titers where applicable/age-appropriate.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description

Subset of subjects with baseline immunity (NAb titer) sufficiently low to enable observation of seroconversion (≤8.5 log2 i.e. ≤4-fold from assay ULOQ) at D56. Only secondary objectives included intent to compare the M5 data with the control sample of similarly aged infants and young children who had received Sabin mOPV2 in a M2 study, which was designed to serve as a historical control for M5.

For further details on results corresponding to M2 study, please refer to NCT02521974.
Arm/Group Title Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1+L2 [2018] Stage II - Group B2H1+H2[2018] M2 Group 2+3 M2 Children
Hide Arm/Group Description:
50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]).
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
114 infants (3 bOPV/1 IPV primed) were to receive at 18 weeks of age one dose of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 2). A randomly selected sub-group of 50 infants were to receive a second dose of Sabin mOPV2 approximately 28 days later (Group 3).
50 IPV and/or OPV vaccinated children aged 1 to <5 years were to receive 2 doses of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 1), separated by 28 days.
Overall Number of Participants Analyzed 19 17 23 42 45 45 48 44 48 39 9
Measure Type: Count of Participants
Unit of Measure: Participants
18
  94.7%
17
 100.0%
22
  95.7%
40
  95.2%
43
  95.6%
44
  97.8%
47
  97.9%
38
  86.4%
48
 100.0%
38
  97.4%
6
  66.7%
5.Secondary Outcome
Title Seroprotection Rates Comparison
Hide Description

Seroprotection rates against type 2 of one or two 106 CCID50 doses of both nOPV2 vaccine candidates in healthy children aged 1 to 5 years and of two doses of both nOPV2 vaccine candidates at both 105 and 106 CCID50 dose levels at approximately 22 weeks of age in infants previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this immunogenicity with a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study (M2) designed and performed to serve as a control for the current study.

Seroprotection rate is defined as the percentage of subjects with type 2-specific neutralizing antibody titers ≥ 1:8 per group.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description

Subset of subjects with baseline immunity (NAb titer) sufficiently low to enable observation of seroconversion (≤8.5 log2 i.e. ≤4-fold from assay ULOQ) at D56. Only secondary objectives included intent to compare the M5 data with the control sample of similarly aged infants and young children who had received Sabin mOPV2 in a M2 study, which was designed to serve as a historical control for M5.

For further details on results corresponding to M2 study, please refer to NCT02521974.
Arm/Group Title Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1+L2 [2018] Stage II - Group B2H1+H2[2018] M2 Group 2+3 M2 Children
Hide Arm/Group Description:
50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]).
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
114 infants (3 bOPV/1 IPV primed) were to receive at 18 weeks of age one dose of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 2). A randomly selected sub-group of 50 infants were to receive a second dose of Sabin mOPV2 approximately 28 days later (Group 3).
50 IPV and/or OPV vaccinated children aged 1 to <5 years were to receive 2 doses of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 1), separated by 28 days.
Overall Number of Participants Analyzed 44 39 46 44 47 46 48 44 48 40 46
Measure Type: Count of Participants
Unit of Measure: Participants
44
 100.0%
39
 100.0%
46
 100.0%
44
 100.0%
46
  97.9%
45
  97.8%
48
 100.0%
43
  97.7%
48
 100.0%
39
  97.5%
46
 100.0%
6.Secondary Outcome
Title Viral Shedding
Hide Description

Level of viral shedding in stool at fixed time points following administration of one or two doses of both nOPV2 candidates at both 105 and 106 CCID50 dose levels in infants at approximately 18-22 weeks of age after having been previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this shedding to a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study designed to serve as a control for the current study.

This is determined by measuring the median number of days taken to get stool cultures negative for poliovirus presence (TTCN stands for median time to culture negative). Kaplan-Meier methods were used to describe the time to cessation of shedding for any shedding (PCR detection).
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description

Subset of subjects corresponding to 2018 Candidates cohorts. 2016 Candidate cohorts did not participate on this endpoint assessment.

Only secondary objectives included intent to compare the M5 data with the control sample of similarly aged infants and young children who had received Sabin mOPV2 in a M2 study, which was designed to serve as a historical control for M5.

For further details on results corresponding to M2 study, please refer to NCT02521974.
Arm/Group Title Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1+L2 [2018] Stage II - Group B2H1+H2[2018] M2 Group 2+3 M2 Children
Hide Arm/Group Description:
50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]).
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later.
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
114 infants (3 bOPV/1 IPV primed) were to receive at 18 weeks of age one dose of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 2). A randomly selected sub-group of 50 infants were to receive a second dose of Sabin mOPV2 approximately 28 days later (Group 3).
50 IPV and/or OPV vaccinated children aged 1 to <5 years were to receive 2 doses of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 1), separated by 28 days.
Overall Number of Participants Analyzed 0 46 51 0 0 125 140 124 141 91 48
Median (95% Confidence Interval)
Unit of Measure: days
5
(4 to 5)
3
(2.5 to 5)
6
(5 to 7)
6
(5 to 7)
6
(5 to 7)
5
(4 to 6)
6
(5 to 7)
6.5
(5 to 9)
7.Secondary Outcome
Title Neurovirulence
Hide Description

Potential for neurovirulence of virus isolated from a subset of stool samples of infants at approximately 18-22 weeks of age after having been previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and following a single dose of both nOPV2 candidates at the 106 CCID50 dose level, as measured in an animal model, and compare this with a control sample (M2 study).

For each of the children / infants receiving a 106 CCID50 dose of the 2018 cohorts as well as all participants in study M2, an exploratory endpoint sample (EES) of poliovirus shed in stools following the first dose was identified, if possible, with which to perform a modified neurovirulence test in a transgenic mouse model. Data from each sample tested was summarized by group per vaccine candidate. The proportion of mice paralyzed and the odds ratio of paralysis from the single-dose assay were the primary means of comparison of neurovirulence of shed virus between each candidate and the Sabin mOPV2 control samples.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description

Per the description under the Outcome Measure Description section, these groups do not match the participants arms distribution, as these results are related to the vaccine candidates behaviour in mice, not to the participating subjects.

Only secondary objectives included intent to compare the M5 data with the control sample of M2 study, which was designed to serve as a historical control for M5. For further details on results corresponding to M2 study, please refer to NCT02521974.
Arm/Group Title mOPV2 nOPV2 C1 2018 nOPV2 C2 2018
Hide Arm/Group Description:
Monovalent Oral Polio Vaccine
Novel Oral Polio Vaccine Candidate 1 - 2018
Novel Oral Polio Vaccine Candidate 1 - 2018
Overall Number of Participants Analyzed 5 22 29
Overall Number of Units Analyzed
Type of Units Analyzed: EES
 5 22 29
Measure Type: Number
Unit of Measure: percentage of neurovirulence
90 0 30
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1+L2 [2018] Stage II - Group B2H1+H2[2018]
Hide Arm/Group Description 50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]). 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days. 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days. 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later. 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later. 162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018). 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later. 162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
All-Cause Mortality
Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1+L2 [2018] Stage II - Group B2H1+H2[2018]
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   0/50 (0.00%)      0/49 (0.00%)      0/51 (0.00%)      0/155 (0.00%)      0/144 (0.00%)      0/138 (0.00%)      0/150 (0.00%)      0/135 (0.00%)      1/151 (0.66%)    
Hide Serious Adverse Events
Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1+L2 [2018] Stage II - Group B2H1+H2[2018]
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   0/50 (0.00%)      1/49 (2.04%)      3/51 (5.88%)      7/155 (4.52%)      1/144 (0.69%)      14/138 (10.14%)      14/150 (9.33%)      9/135 (6.67%)      15/151 (9.93%)    
Cardiac disorders                   
Ventricular Septal Defect † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Congenital, familial and genetic disorders                   
Congeniital Cortical Blindness † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  1/135 (0.74%)  0/151 (0.00%) 
Ear and labyrinth disorders                   
Soft Tissue Abscess (preauricular) † 1  0/50 (0.00%)  0/49 (0.00%)  1/51 (1.96%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0 0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Gastrointestinal disorders                   
Acute Diarrheal Disease † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Acute Gastroenteritis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  2/135 (1.48%)  0/151 (0.00%) 
General disorders                   
Urticaria † 1  0/50 (0.00%)  0/49 (0.00%)  1/51 (1.96%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Infections and infestations                   
Sepsis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
Nervous system disorders                   
Tonic clonic seizure † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  2 0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Renal and urinary disorders                   
Urinary Tract Infection † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  1/135 (0.74%)  1/151 (0.66%) 
Respiratory, thoracic and mediastinal disorders                   
Bronchiolitis † 1  0/50 (0.00%)  1/49 (2.04%)  1/51 (1.96%)  2/155 (1.29%)  0/144 (0.00%)  9/138 (6.52%)  8/150 (5.33%)  2/135 (1.48%)  10/151 (6.62%) 
Pneumonia † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  4/155 (2.58%)  1/144 (0.69%)  4/138 (2.90%)  7 6/150 (4.00%)  4/135 (2.96%)  3/151 (1.99%) 
Asthma † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
Skin and subcutaneous tissue disorders                   
Second degree burn † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Withlow left hand † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Subcutaneous abscess † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
1
Term from vocabulary, MedDRA (22.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stage I - Group A2H2 Stage II - A1H2 [2018] Stage II - A2H2 [2018] Stage I -- Group B2L1+L2[2016] Stage I - B2H1+H2[2016] Stage II - Group B1L1+L2[2018] Stage II - Group B1H1+H2[2018] Stage II - Group B2L1+L2 [2018] Stage II - Group B2H1+H2[2018]
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   40/50 (80.00%)      36/49 (73.47%)      44/51 (86.27%)      82/155 (52.90%)      93/144 (64.58%)      129/138 (93.48%)      127/150 (84.67%)      118/135 (87.41%)      126/151 (83.44%)    
Blood and lymphatic system disorders                   
Anaemia † 1  1/50 (2.00%)  0/49 (0.00%)  1/51 (1.96%)  4/155 (2.58%)  6/144 (4.17%)  3/138 (2.17%)  2/150 (1.33%)  1/135 (0.74%)  6/151 (3.97%) 
Microcytic Anaemia † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  9/155 (5.81%)  3/144 (2.08%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  5/151 (3.31%) 
Iron Deficiency Anaemia † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  3/155 (1.94%)  3/144 (2.08%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Hypochromic Anaemia † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  1/144 (0.69%)  4/138 (2.90%)  5/150 (3.33%)  5/135 (3.70%)  6/151 (3.97%) 
Normocytic Anaemia † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  3/155 (1.94%)  0/144 (0.00%)  1/138 (0.72%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
Eosinophilia † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  2/151 (1.32%) 
Ear and labyrinth disorders                   
External Ear Inflammation † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  1/144 (0.69%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Eye disorders                   
Conjunctival Hyperaemia † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Dacryostenosis acquired † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Strabismus † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  2/135 (1.48%)  0/151 (0.00%) 
Blindness Cortical † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  1/135 (0.74%)  0/151 (0.00%) 
Gastrointestinal disorders                   
Vomiting † 1 [1]  6/50 (12.00%)  5/49 (10.20%)  6/51 (11.76%)  20/155 (12.90%)  21/144 (14.58%)  19/138 (13.77%)  22/150 (14.67%)  20/135 (14.81%)  19/151 (12.58%) 
Diarrhoea † 1  11/50 (22.00%)  9/49 (18.37%)  4/51 (7.84%)  9/155 (5.81%)  7/144 (4.86%)  2/138 (1.45%)  9/150 (6.00%)  1/135 (0.74%)  4/151 (2.65%) 
Teething † 1  1/50 (2.00%)  5/49 (10.20%)  2/51 (3.92%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Constipation † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  8/150 (5.33%)  1/135 (0.74%)  0/151 (0.00%) 
Infantile Colic † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  2/144 (1.39%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Food Poisoning † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Abdominal Pain † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Haematochezia † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Stomatitis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  0/150 (0.00%)  1/135 (0.74%)  0/151 (0.00%) 
Gastroesophageal Reflux Disease † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
General disorders                   
Irritability † 1 [1]  2/50 (4.00%)  3/49 (6.12%)  5/51 (9.80%)  30/155 (19.35%)  18/144 (12.50%)  23/138 (16.67%)  27/150 (18.00%)  25/135 (18.52%)  25/151 (16.56%) 
Abnormal crying † 1 [1]  2/50 (4.00%)  7/49 (14.29%)  5/51 (9.80%)  35/155 (22.58%)  24/144 (16.67%)  26/138 (18.84%)  24/150 (16.00%)  21/135 (15.56%)  25/151 (16.56%) 
Fever † 1 [1]  6/50 (12.00%)  12/49 (24.49%)  15/51 (29.41%)  14/155 (9.03%)  12/144 (8.33%)  15/138 (10.87%)  12/150 (8.00%)  20/135 (14.81%)  18/151 (11.92%) 
Loss of Appetite † 1 [1]  16/50 (32.00%)  13/49 (26.53%)  13/51 (25.49%)  22/155 (14.19%)  13/144 (9.03%)  11/138 (7.97%)  15/150 (10.00%)  14/135 (10.37%)  19/151 (12.58%) 
Drowsiness † 1 [1]  2/50 (4.00%)  9/49 (18.37%)  5/51 (9.80%)  8/155 (5.16%)  9/144 (6.25%)  6/138 (4.35%)  11/150 (7.33%)  10/135 (7.41%)  15/151 (9.93%) 
Malaise † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  1/144 (0.69%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Immune system disorders                   
Allergy to arthropod bite † 1  0/50 (0.00%)  3/49 (6.12%)  3/51 (5.88%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
Hypersensitivity † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Milk Allergy † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  2/155 (1.29%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Drug Hypersensitivity † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  1/135 (0.74%)  0/151 (0.00%) 
Food Allergy † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  1/135 (0.74%)  0/151 (0.00%) 
Infections and infestations                   
Influenza † 1  9/50 (18.00%)  23/49 (46.94%)  25/51 (49.02%)  1/155 (0.65%)  1/144 (0.69%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Pharyngotonsillitis † 1  4/50 (8.00%)  7/49 (14.29%)  8/51 (15.69%)  1/155 (0.65%)  1/144 (0.69%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  1/151 (0.66%) 
Nasopharyngitis † 1  18/50 (36.00%)  2/49 (4.08%)  4/51 (7.84%)  52/155 (33.55%)  65/144 (45.14%)  62/138 (44.93%)  71/150 (47.33%)  69/135 (51.11%)  78/151 (51.66%) 
Gastroenteritis † 1  2/50 (4.00%)  6/49 (12.24%)  6/51 (11.76%)  1/155 (0.65%)  2/144 (1.39%)  4/138 (2.90%)  2/150 (1.33%)  2/135 (1.48%)  1/151 (0.66%) 
Rhinitis † 1  5/50 (10.00%)  5/49 (10.20%)  5/51 (9.80%)  11/155 (7.10%)  8/144 (5.56%)  5/138 (3.62%)  3/150 (2.00%)  7/135 (5.19%)  5/151 (3.31%) 
Otitis † 1  0/50 (0.00%)  3/49 (6.12%)  4/51 (7.84%)  0/155 (0.00%)  3/144 (2.08%)  1/138 (0.72%)  0/150 (0.00%)  2/135 (1.48%)  0/151 (0.00%) 
Tonsillitis † 1  1/50 (2.00%)  1/49 (2.04%)  6/51 (11.76%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Bronchitis † 1  1/50 (2.00%)  2/49 (4.08%)  2/51 (3.92%)  0/155 (0.00%)  1/144 (0.69%)  0/138 (0.00%)  0/150 (0.00%)  1/135 (0.74%)  0/151 (0.00%) 
Varicella † 1  0/50 (0.00%)  1/49 (2.04%)  2/51 (3.92%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  1/135 (0.74%)  0/151 (0.00%) 
Upper Respiratory Tract Infection † 1  0/50 (0.00%)  3/49 (6.12%)  1/51 (1.96%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  1/151 (0.66%) 
Hand-foot-and-mouth disease † 1  0/50 (0.00%)  3/49 (6.12%)  2/51 (3.92%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
Bronchiolitis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  3/155 (1.94%)  1/144 (0.69%)  1/138 (0.72%)  7/150 (4.67%)  1/135 (0.74%)  9/151 (5.96%) 
Exanthema subitum † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  3/155 (1.94%)  3/144 (2.08%)  0/138 (0.00%)  1/150 (0.67%)  3/135 (2.22%)  1/151 (0.66%) 
Urinary Tract Infection † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  4/155 (2.58%)  0/144 (0.00%)  1/138 (0.72%)  2/150 (1.33%)  0/135 (0.00%)  2/151 (1.32%) 
Conjunctivitis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  1/138 (0.72%)  3/150 (2.00%)  0/135 (0.00%)  2/151 (1.32%) 
Pharyngitis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  2/155 (1.29%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  1/135 (0.74%)  0/151 (0.00%) 
Acarodermatitis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  1/144 (0.69%)  4/138 (2.90%)  7/150 (4.67%)  3/135 (2.22%)  1/151 (0.66%) 
Pneumonia † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  3/155 (1.94%)  0/144 (0.00%)  2/138 (1.45%)  4/150 (2.67%)  1/135 (0.74%)  4/151 (2.65%) 
Oral Candidiasis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  1/144 (0.69%)  1/138 (0.72%)  0/150 (0.00%)  1/135 (0.74%)  1/151 (0.66%) 
Impetigo † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  3/155 (1.94%)  0/144 (0.00%)  2/138 (1.45%)  1/150 (0.67%)  2/135 (1.48%)  0/151 (0.00%) 
Viral Conjunctivitis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Viral Gastroenteritis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Viral Infection † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  1/144 (0.69%)  0/138 (0.00%)  1/150 (0.67%)  1/135 (0.74%)  2/151 (1.32%) 
Cellulitis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Eye Infection Bacterial † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
Pyoderma † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  1/144 (0.69%)  0/138 (0.00%)  3/150 (2.00%)  0/135 (0.00%)  2/151 (1.32%) 
Herpangina † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  1/144 (0.69%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Body Tinea † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  2/138 (1.45%)  2/150 (1.33%)  1/135 (0.74%)  1/151 (0.66%) 
Fungal Infection † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Abscess † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Abscess Jaw † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Amoebiasis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Amoebic Dysentery † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Ear Infection † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Roseola † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
Spinal Cord Abscess † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Subcutaneous abscess † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Tinea Versicolour † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Conjunctivitis Bacterial † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
Infected Bite Infection † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  1/135 (0.74%)  0/151 (0.00%) 
Urinary Tract Infection Bacterial † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
Injury, poisoning and procedural complications                   
Head Injury † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  2/150 (1.33%)  0/135 (0.00%)  0/151 (0.00%) 
Burns Second Degree † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Thermal Burn † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  1/144 (0.69%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Eye Injury † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
Investigations                   
Transaminases increase † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  1/144 (0.69%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Metabolism and nutrition disorders                   
Overweight † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  3/155 (1.94%)  2/144 (1.39%)  2/138 (1.45%)  3/150 (2.00%)  7/135 (5.19%)  4/151 (2.65%) 
Obesity † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  1/144 (0.69%)  1/138 (0.72%)  1/150 (0.67%)  2/135 (1.48%)  0/151 (0.00%) 
Underweight † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  2/144 (1.39%)  0/138 (0.00%)  0/150 (0.00%)  1/135 (0.74%)  0/151 (0.00%) 
Nervous system disorders                   
Febrile Convulsion † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Gross Motor Delay † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Hypotonia † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Motor Developmental Delay † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Psychiatric disorders                   
Neurodevelopmental Disorder † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  1/144 (0.69%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Psychomotor Retardation † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  1/138 (0.72%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Renal and urinary disorders                   
Pyelocaliectasis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
Respiratory, thoracic and mediastinal disorders                   
Cough † 1  0/50 (0.00%)  1/49 (2.04%)  0/51 (0.00%)  0/155 (0.00%)  2/144 (1.39%)  0/138 (0.00%)  1/150 (0.67%)  1/135 (0.74%)  0/151 (0.00%) 
Nasal Congestion † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  2/155 (1.29%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Rhinorrhoea † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  1/151 (0.66%) 
Skin and subcutaneous tissue disorders                   
Dermatitis Allergic † 1  1/50 (2.00%)  2/49 (4.08%)  3/51 (5.88%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Dermatitis Diaper † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  5/155 (3.23%)  2/144 (1.39%)  6/138 (4.35%)  10/150 (6.67%)  5/135 (3.70%)  5/151 (3.31%) 
Urticaria † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Rash † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  1/144 (0.69%)  1/138 (0.72%)  2/150 (1.33%)  0/135 (0.00%)  4/151 (2.65%) 
Pruritus † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  1/144 (0.69%)  0/138 (0.00%)  0/150 (0.00%)  0/135 (0.00%)  0/151 (0.00%) 
Dermatitis † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  1/144 (0.69%)  0/138 (0.00%)  3/150 (2.00%)  1/135 (0.74%)  1/151 (0.66%) 
Dermatitis Atopic † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  0/144 (0.00%)  1/138 (0.72%)  4/150 (2.67%)  5/135 (3.70%)  5/151 (3.31%) 
Dermatitis Contact † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/155 (0.65%)  3/144 (2.08%)  1/138 (0.72%)  2/150 (1.33%)  1/135 (0.74%)  0/151 (0.00%) 
Skin lesion † 1  0/50 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/155 (0.00%)  0/144 (0.00%)  0/138 (0.00%)  1/150 (0.67%)  0/135 (0.00%)  0/151 (0.00%) 
1
Term from vocabulary, MedDRA (22.0)
†
Indicates events were collected by systematic assessment
[1]
Solicited AE
[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: Ricardo Rüttimann, PhD
Organization: FIDEC Corporation
Phone: +5491161188536
EMail: rruttimann@fidec-online.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Fidec Corporation
ClinicalTrials.gov Identifier: NCT03554798    
Other Study ID Numbers: M5 ABMG
First Submitted: May 8, 2018
First Posted: June 13, 2018
Results First Submitted: January 20, 2022
Results First Posted: March 23, 2022
Last Update Posted: January 19, 2024