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A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older (EVERGREEN)

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ClinicalTrials.gov Identifier: NCT04908683
Recruitment Status : Completed
First Posted : June 1, 2021
Results First Posted : February 8, 2024
Last Update Posted : February 8, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Respiratory Syncytial Viruses
Lower Respiratory Tract Disease
Interventions Biological: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Biological: Placebo
Enrollment 25236
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1. Participants received a single IM injection of matching placebo on Day 1.
Period Title: Overall Study
Started 16817 8419
Randomized and Vaccinated 16709 8367
Completed 124 59
Not Completed 16693 8360
Reason Not Completed
Failure to meet continuation criteria             34             22
Initiated prohibited medication             3             0
Randomized by mistake             1             0
Lost to Follow-up             679             341
Participant met eligibility criteria but were not needed             3             1
Physician Decision             44             35
Technical problems             12             9
Withdrawal by legally authorized representative             1             0
Protocol Violation             2             0
Withdrawal by Subject             1188             570
Site Closure by Sponsor             6             3
Adverse Event             21             11
Death             101             61
Sponsor's decision             14398             7205
Other             92             50
Randomized not vaccinated             108             52
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo Total
Hide Arm/Group Description Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1. Participants received a single IM injection of matching placebo on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 16709 8367 25076
Hide Baseline Analysis Population Description
Baseline characteristics data were analyzed on full analysis set (FAS) which included all participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16709 participants 8367 participants 25076 participants
70.2  (5.24) 70.2  (5.23) 70.2  (5.24)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16709 participants 8367 participants 25076 participants
Adults (60-64 years)
1472
   8.8%
740
   8.8%
2212
   8.8%
From 65 to 84 years
15053
  90.1%
7534
  90.0%
22587
  90.1%
85 years and over
184
   1.1%
93
   1.1%
277
   1.1%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16709 participants 8367 participants 25076 participants
Female
9063
  54.2%
4452
  53.2%
13515
  53.9%
Male
7645
  45.8%
3913
  46.8%
11558
  46.1%
Others
1
   0.0%
2
   0.0%
3
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16709 participants 8367 participants 25076 participants
Hispanic or Latino
1555
   9.3%
741
   8.9%
2296
   9.2%
Not Hispanic or Latino
14903
  89.2%
7496
  89.6%
22399
  89.3%
Unknown or Not Reported
251
   1.5%
130
   1.6%
381
   1.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16709 participants 8367 participants 25076 participants
American Indian or Alaska Native
58
   0.3%
17
   0.2%
75
   0.3%
Asian
1757
  10.5%
897
  10.7%
2654
  10.6%
Native Hawaiian or Other Pacific Islander
98
   0.6%
49
   0.6%
147
   0.6%
Black or African American
1820
  10.9%
935
  11.2%
2755
  11.0%
White
12649
  75.7%
6297
  75.3%
18946
  75.6%
More than one race
189
   1.1%
101
   1.2%
290
   1.2%
Unknown or Not Reported
138
   0.8%
71
   0.8%
209
   0.8%
1.Primary Outcome
Title Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)
Hide Description Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the respiratory infection intensity and impact questionnaire (RiiQ, version 2) at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-item questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).
Time Frame From Baseline (Day 1) up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol efficacy (PPE) population included all randomized and vaccinated participants, excluding those with major protocol deviations (MPDs) expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 16263 8152
Measure Type: Count of Participants
Unit of Measure: Participants
44
   0.3%
63
   0.8%
2.Secondary Outcome
Title Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)
Hide Description A participant was considered to have RT-PCR-confirmed RSV-mediated ARI if the following protocol defined criteria were met: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total ARI symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).
Time Frame From Baseline (Day 1) up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
PPE population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 16263 8152
Measure Type: Count of Participants
Unit of Measure: Participants
77
   0.5%
101
   1.2%
3.Secondary Outcome
Title Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year
Hide Description Number of participants with first occurrence of any RT-PCR-confirmed RSV mediated LRTD during the second year were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the RiiQ, version 2 at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).
Time Frame From Month 12 up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
PPE population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 10031 5011
Measure Type: Count of Participants
Unit of Measure: Participants
16
   0.2%
29
   0.6%
4.Secondary Outcome
Title Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year
Hide Description A participant was considered to have RT-PCR-confirmed RSV-mediated ARI according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated ARI if the following criteria were met: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total ARI symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).
Time Frame From Month 12 up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
PPE population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 10031 5011
Measure Type: Count of Participants
Unit of Measure: Participants
39
   0.4%
44
   0.9%
5.Secondary Outcome
Title Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study
Hide Description A participant was considered to have clinically relevant disease with specific parameters associated with an RT-PCR-confirmed RSV-mediated ARI if the following criteria were met: the participant had an RT-PCR-confirmed RSV-mediated ARI: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample; any of the following associated with ARI: hospitalization, emergency department visit, per clinical judgement of complications, decreased oxygen saturation, tachypnea, need of supplemental oxygen, hypotension, pulmonary function test and arterial blood gas result.
Time Frame Baseline (Day 1) up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
PPE population is defined as population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 16263 8152
Measure Type: Count of Participants
Unit of Measure: Participants
4
   0.0%
11
   0.1%
6.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description Number of participants with SAEs were reported. An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time Frame 28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 16709 8367
Measure Type: Count of Participants
Unit of Measure: Participants
28 days post vaccination on Day 1 Number Analyzed 16709 participants 8367 participants
119
   0.7%
53
   0.6%
First year follow-up Number Analyzed 16532 participants 8275 participants
446
   2.7%
239
   2.9%
7.Secondary Outcome
Title Number of Participants With Potential Adverse Events of Special Interest (AESIs)
Hide Description Number of participants with potential AESIs were reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs were embolic and thrombotic events, hematopoietic thrombocytopenia, and cerebral hemorrhage.
Time Frame 28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 16709 8367
Measure Type: Count of Participants
Unit of Measure: Participants
28 days post vaccination on Day 1 Number Analyzed 16709 participants 8367 participants
25
   0.1%
4
   0.0%
First year follow-up Number Analyzed 16532 participants 8275 participants
71
   0.4%
35
   0.4%
8.Secondary Outcome
Title Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination
Hide Description Number of participants with solicited local AEs 7 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling, and pain/tenderness at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). All solicited AEs at the injection site (local) were considered related to the study vaccine administration.
Time Frame Up to Day 7 post vaccination on Day 1 (up to Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety subset included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination). Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 2305 1155
Measure Type: Count of Participants
Unit of Measure: Participants
1076
  46.7%
169
  14.6%
9.Secondary Outcome
Title Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination
Hide Description Number of participants with solicited systemic AEs 7 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fatigue, headache, myalgia, nausea, pyrexia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time Frame Up to Day 7 post vaccination on Day 1 (up to Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety subset (a subset of FAS) included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination). Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 2305 1155
Measure Type: Count of Participants
Unit of Measure: Participants
1018
  44.2%
236
  20.4%
10.Secondary Outcome
Title Number of Participants With Unsolicited AEs up to 28 Days After Vaccination
Hide Description Number of participants with unsolicited AEs 28 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Unsolicited adverse events included all adverse events for which the participant was not specifically questioned in the subject diary.
Time Frame Up to 28 days post vaccination on Day 1 (up to Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety subset (a subset of FAS) included all participants that consented to the collection of AEs (unsolicited AEs for 28 days after vaccination). Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 2330 1165
Measure Type: Count of Participants
Unit of Measure: Participants
554
  23.8%
206
  17.7%
11.Secondary Outcome
Title Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination
Hide Description RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
Time Frame At 14 Days post vaccination on Day 1 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Immunogenicity (PPI) population included all randomized and vaccinated participants who were part of the immunogenicity subset (consisted of at least 360 participants, of whom ~50% were at increased risk for severe RSV disease and ~50% were 75 years or older) and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 219 108
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
7194
(6394 to 8093)
537
(455 to 634)
12.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) Antibodies Immunoglobulin G (IgG) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days Post Vaccination
Hide Description GMTs of preF antibodies IgG at 14 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.
Time Frame At 14 days post vaccination on Day 1 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
PPI population included all randomized and vaccinated participants who were part of the immunogenicity subset and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 219 108
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
4932
(4477 to 5433)
410
(348 to 484)
13.Secondary Outcome
Title T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
Hide Description T-cell IFN gamma responses to RSV F protein specific peptides at 14 days after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
Time Frame 14 days post vaccination on Day 1 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
PPI population included all randomized and vaccinated participants who were part of the immuno subset and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 185 92
Median (Full Range)
Unit of Measure: SFC/10^6 PBMCs
533
(306 to 873)
NA [1] 
(NA to 78)
[1]
Median and lower limit of full range could not be estimated as it was below the lower limit of quantification (LLOQ: 68 SFC/10^6 PBMCs ).
14.Secondary Outcome
Title Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score
Hide Description RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. The respiratory symptoms included 2 upper respiratory tract infection (URTI) symptoms (nasal congestion and sore throat), 4 lower respiratory tract infection (LRTI) symptoms (cough, wheezing, short of breath, and coughing up phlegm/sputum) and 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, and loss of appetite). Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. RiiQ total Symptom score was the mean of all scores (based on 13 symptoms). The AUC of the change from baseline for the RiiQ total symptom score and the RiiQ lower respiratory symptom score during the ARI was calculated.
Time Frame Baseline (Day 1) up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
PPE population includes all randomized and vaccinated participants, excluding those with major protocol deviations (MPDs) expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description:
Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Participants received a single IM injection of matching placebo on Day 1.
Overall Number of Participants Analyzed 115 143
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale*hours
82
(21 to 141)
107
(48 to 218)
Time Frame From Day 1 up to 24 months post-vaccination on Day 1 (Day 731).
Adverse Event Reporting Description All-cause mortality and serious adverse events (SAEs) were analyzed on Full Analysis Set (FAS) population. Other (not including serious) AEs as solicited and unsolicited AEs were collected and analyzed on a subset of FAS that is called safety subset. The safety subset included all participants that consented to the collection of AEs (solicited and unsolicited AEs).
 
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Hide Arm/Group Description Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1. Participants received a single IM injection of matching placebo on Day 1.
All-Cause Mortality
Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   105/16709 (0.63%)      61/8367 (0.73%)    
Hide Serious Adverse Events
Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   842/16709 (5.04%)      457/8367 (5.46%)    
Blood and lymphatic system disorders     
Anaemia * 1  5/16709 (0.03%)  5 1/8367 (0.01%)  1
Anaemia Megaloblastic * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Disseminated Intravascular Coagulation * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Iron Deficiency Anaemia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Leukocytosis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Lymphadenopathy Mediastinal * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Thrombocytopenia * 1  4/16709 (0.02%)  4 3/8367 (0.04%)  3
Cardiac disorders     
Acute Coronary Syndrome * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Acute Left Ventricular Failure * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Acute Myocardial Infarction * 1  17/16709 (0.10%)  17 10/8367 (0.12%)  10
Angina Pectoris * 1  6/16709 (0.04%)  6 2/8367 (0.02%)  2
Angina Unstable * 1  2/16709 (0.01%)  2 4/8367 (0.05%)  4
Aortic Valve Incompetence * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Aortic Valve Stenosis * 1  0/16709 (0.00%)  0 2/8367 (0.02%)  3
Arrhythmia * 1  2/16709 (0.01%)  2 2/8367 (0.02%)  2
Arteriosclerosis Coronary Artery * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Atrial Fibrillation * 1  24/16709 (0.14%)  24 13/8367 (0.16%)  13
Atrial Flutter * 1  0/16709 (0.00%)  0 2/8367 (0.02%)  2
Atrial Thrombosis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Atrioventricular Block Complete * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Atrioventricular Block Second Degree * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Bradyarrhythmia * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Bradycardia * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Cardiac Arrest * 1  8/16709 (0.05%)  8 1/8367 (0.01%)  1
Cardiac Failure * 1  7/16709 (0.04%)  7 4/8367 (0.05%)  4
Cardiac Failure Chronic * 1  0/16709 (0.00%)  0 2/8367 (0.02%)  2
Cardiac Failure Congestive * 1  15/16709 (0.09%)  16 6/8367 (0.07%)  7
Cardiac Valve Disease * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Cardiac Ventricular Thrombosis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Cardio-Respiratory Arrest * 1  3/16709 (0.02%)  3 1/8367 (0.01%)  1
Cardiogenic Shock * 1  0/16709 (0.00%)  0 2/8367 (0.02%)  2
Cardiomyopathy * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Chronic Coronary Syndrome * 1  1/16709 (0.01%)  2 0/8367 (0.00%)  0
Conduction Disorder * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Congestive Cardiomyopathy * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Cor Pulmonale * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Cor Pulmonale Chronic * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Coronary Artery Disease * 1  14/16709 (0.08%)  14 11/8367 (0.13%)  12
Coronary Artery Occlusion * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Coronary Artery Thrombosis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hypertensive Heart Disease * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Interventricular Septum Rupture * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Ischaemic Cardiomyopathy * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Mitral Valve Disease * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Mitral Valve Incompetence * 1  3/16709 (0.02%)  3 1/8367 (0.01%)  1
Mitral Valve Stenosis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Myocardial Infarction * 1  23/16709 (0.14%)  24 12/8367 (0.14%)  13
Myocardial Ischaemia * 1  1/16709 (0.01%)  1 2/8367 (0.02%)  4
Pericardial Effusion * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Pericarditis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Sinus Arrest * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Sinus Bradycardia * 1  0/16709 (0.00%)  0 3/8367 (0.04%)  3
Sinus Tachycardia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Stress Cardiomyopathy * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Supraventricular Tachycardia * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Tachycardia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Ventricular Arrhythmia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Ventricular Extrasystoles * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Ventricular Tachycardia * 1  3/16709 (0.02%)  4 1/8367 (0.01%)  1
Congenital, familial and genetic disorders     
Hypertrophic Cardiomyopathy * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Vitello-Intestinal Duct Remnant * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Ear and labyrinth disorders     
Vertigo * 1  1/16709 (0.01%)  1 3/8367 (0.04%)  3
Endocrine disorders     
Goitre * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hypothyroidism * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Myxoedema * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pituitary Cyst * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Eye disorders     
Angle Closure Glaucoma * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Cataract * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Diplopia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Ocular Myasthenia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pterygium * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Vision Blurred * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Gastrointestinal disorders     
Abdominal Hernia * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Abdominal Pain * 1  5/16709 (0.03%)  5 0/8367 (0.00%)  0
Abdominal Pain Upper * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Anal Fissure * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Chronic Gastritis * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  2
Colitis * 1  3/16709 (0.02%)  3 2/8367 (0.02%)  2
Constipation * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Crohn's Disease * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Diarrhoea * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Diverticular Perforation * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Diverticulum Intestinal Haemorrhagic * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Duodenal Perforation * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Duodenal Ulcer * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Duodenal Ulcer Haemorrhage * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Duodenitis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Dyspepsia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Gastric Polyps * 1  1/16709 (0.01%)  2 0/8367 (0.00%)  0
Gastric Ulcer * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Gastric Ulcer Haemorrhage * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Gastric Ulcer Perforation * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Gastritis * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  2
Gastritis Erosive * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Gastrointestinal Haemorrhage * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Gastrointestinal Perforation * 1  1/16709 (0.01%)  3 0/8367 (0.00%)  0
Gastrointestinal Ulcer * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Gastrooesophageal Reflux Disease * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Haemorrhoids * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hiatus Hernia * 1  5/16709 (0.03%)  7 0/8367 (0.00%)  0
Ileus * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Inguinal Hernia * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Inguinal Hernia Strangulated * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Intestinal Obstruction * 1  6/16709 (0.04%)  7 1/8367 (0.01%)  1
Intestinal Perforation * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Irritable Bowel Syndrome * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Large Intestine Perforation * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Large Intestine Polyp * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Mesenteric Panniculitis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Oesophageal Haemorrhage * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Oesophageal Rupture * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Oesophageal Varices Haemorrhage * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Oesophagitis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pancreatitis * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Pancreatitis Acute * 1  2/16709 (0.01%)  2 2/8367 (0.02%)  2
Peptic Ulcer Haemorrhage * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Rectal Polyp * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Small Intestinal Obstruction * 1  8/16709 (0.05%)  8 1/8367 (0.01%)  1
Small Intestinal Perforation * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Spigelian Hernia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Tongue Dysplasia * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Upper Gastrointestinal Haemorrhage * 1  3/16709 (0.02%)  3 2/8367 (0.02%)  2
General disorders     
Accidental Death * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Asthenia * 1  0/16709 (0.00%)  0 2/8367 (0.02%)  2
Chest Discomfort * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Chest Pain * 1  3/16709 (0.02%)  3 4/8367 (0.05%)  4
Complication Associated with Device * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Death * 1  18/16709 (0.11%)  18 18/8367 (0.22%)  18
Drowning * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Drug Withdrawal Syndrome * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Fatigue * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Hypothermia * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Malaise * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Multiple Organ Dysfunction Syndrome * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Non-Cardiac Chest Pain * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Pain * 1  1/16709 (0.01%)  2 0/8367 (0.00%)  0
Prosthetic Cardiac Valve Thrombosis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pyrexia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Sudden Death * 1  2/16709 (0.01%)  2 2/8367 (0.02%)  2
Vascular Stent Stenosis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  2
Hepatobiliary disorders     
Bile Duct Stone * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Biliary Tract Disorder * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Cholangitis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Cholangitis Acute * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Cholecystitis * 1  4/16709 (0.02%)  4 8/8367 (0.10%)  8
Cholecystitis Acute * 1  4/16709 (0.02%)  4 1/8367 (0.01%)  1
Cholecystitis Chronic * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Cholelithiasis * 1  3/16709 (0.02%)  3 2/8367 (0.02%)  2
Hepatic Cirrhosis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Hepatic Failure * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Hepatic Haemorrhage * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hepatorenal Syndrome * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Immune system disorders     
Amyloidosis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Anaphylactic Reaction * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Anaphylactic Shock * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Drug Hypersensitivity * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Infections and infestations     
Abdominal Abscess * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  2
Abscess * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Abscess Jaw * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Abscess Limb * 1  3/16709 (0.02%)  4 1/8367 (0.01%)  1
Anal Abscess * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Anorectal Cellulitis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Appendicitis * 1  2/16709 (0.01%)  2 2/8367 (0.02%)  2
Appendicitis Perforated * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Arthritis Bacterial * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Bacteraemia * 1  1/16709 (0.01%)  1 2/8367 (0.02%)  2
Bacterial Infection * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Beta Haemolytic Streptococcal Infection * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Bronchitis * 1  3/16709 (0.02%)  3 1/8367 (0.01%)  1
Bronchitis Viral * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Carbuncle * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Cellulitis * 1  6/16709 (0.04%)  7 5/8367 (0.06%)  5
Cellulitis Staphylococcal * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Clostridium Colitis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Clostridium Difficile Infection * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Colonic Abscess * 1  1/16709 (0.01%)  3 2/8367 (0.02%)  2
Coronavirus Infection * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Coronavirus Pneumonia * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Covid-19 * 1  29/16709 (0.17%)  29 12/8367 (0.14%)  12
Covid-19 Pneumonia * 1  6/16709 (0.04%)  6 4/8367 (0.05%)  4
Cystitis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Diabetic Foot Infection * 1  1/16709 (0.01%)  2 0/8367 (0.00%)  0
Diverticulitis * 1  5/16709 (0.03%)  5 5/8367 (0.06%)  5
Diverticulitis Intestinal Perforated * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Enterococcal Sepsis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Enterocolitis Infectious * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Epiglottic Abscess * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Erysipelas * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Escherichia Sepsis * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Extradural Abscess * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Fungaemia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Gangrene * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Gastroenteritis * 1  5/16709 (0.03%)  5 2/8367 (0.02%)  2
Gastroenteritis Salmonella * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Gastroenteritis Viral * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Helicobacter Gastritis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Herpes Zoster * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Infected Bite * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Infected Skin Ulcer * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Infection * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Infectious Pleural Effusion * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Influenza * 1  2/16709 (0.01%)  2 4/8367 (0.05%)  4
Intervertebral Discitis * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Kidney Infection * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Liver Abscess * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Localised Infection * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Lower Respiratory Tract Infection * 1  7/16709 (0.04%)  8 3/8367 (0.04%)  3
Lung Abscess * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Meningoencephalitis Herpetic * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Metapneumovirus Infection * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Osteomyelitis * 1  2/16709 (0.01%)  2 2/8367 (0.02%)  2
Perirectal Abscess * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Peritonitis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pharyngitis Streptococcal * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pneumonia * 1  46/16709 (0.28%)  48 26/8367 (0.31%)  26
Pneumonia Aspiration * 1  5/16709 (0.03%)  5 2/8367 (0.02%)  2
Pneumonia Bacterial * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Pneumonia Influenzal * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Pneumonia Legionella * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pneumonia Streptococcal * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Postoperative Abscess * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Postoperative Wound Infection * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pyelonephritis * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Renal Abscess * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Respiratory Tract Infection * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Rhinovirus Infection * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Sepsis * 1  15/16709 (0.09%)  15 9/8367 (0.11%)  10
Septic Shock * 1  4/16709 (0.02%)  4 3/8367 (0.04%)  3
Sinusitis Fungal * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Staphylococcal Infection * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Streptococcal Sepsis * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Upper Respiratory Tract Infection * 1  3/16709 (0.02%)  3 1/8367 (0.01%)  1
Urinary Tract Infection * 1  7/16709 (0.04%)  10 4/8367 (0.05%)  4
Urosepsis * 1  0/16709 (0.00%)  0 3/8367 (0.04%)  3
Viral Labyrinthitis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Wound Infection * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental Overdose * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Alcohol Poisoning * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Ankle Fracture * 1  1/16709 (0.01%)  1 4/8367 (0.05%)  4
Arterial Injury * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Asbestosis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Back Injury * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Bone Contusion * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Cervical Vertebral Fracture * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Clavicle Fracture * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Concussion * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Contusion * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Craniocerebral Injury * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Extradural Haematoma * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Eye Contusion * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Face Injury * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Facial Bones Fracture * 1  0/16709 (0.00%)  0 3/8367 (0.04%)  3
Fall * 1  5/16709 (0.03%)  5 4/8367 (0.05%)  4
Femoral Neck Fracture * 1  1/16709 (0.01%)  1 2/8367 (0.02%)  2
Femur Fracture * 1  8/16709 (0.05%)  9 5/8367 (0.06%)  5
Fibula Fracture * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Foot Fracture * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Forearm Fracture * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Foreign Body in Skin or Subcutaneous Tissue * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Gun Shot Wound * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hand Fracture * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Head Injury * 1  3/16709 (0.02%)  3 2/8367 (0.02%)  2
Hip Fracture * 1  6/16709 (0.04%)  6 3/8367 (0.04%)  3
Humerus Fracture * 1  4/16709 (0.02%)  4 3/8367 (0.04%)  3
Injury * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Joint Dislocation * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Joint Injury * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Ligament Rupture * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Limb Injury * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Liver Contusion * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Lower Limb Fracture * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Lumbar Vertebral Fracture * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Meniscus Injury * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Multiple Fractures * 1  1/16709 (0.01%)  1 3/8367 (0.04%)  3
Neck Injury * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Patella Fracture * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Pelvic Fracture * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Periprocedural Myocardial Infarction * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Periprosthetic Fracture * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Pneumothorax Traumatic * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Post Procedural Complication * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Post Vaccination Syndrome * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Postoperative Ileus * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Procedural Complication * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Procedural Pain * 1  3/16709 (0.02%)  3 1/8367 (0.01%)  1
Radius Fracture * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Rib Fracture * 1  10/16709 (0.06%)  10 4/8367 (0.05%)  4
Road Traffic Accident * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Seroma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Skin Injury * 1  0/16709 (0.00%)  0 2/8367 (0.02%)  2
Skin Laceration * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Skin Wound * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Skull Fracture * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Spinal Fracture * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Subdural Haematoma * 1  6/16709 (0.04%)  7 1/8367 (0.01%)  1
Subdural Haemorrhage * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Tendon Rupture * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Thoracic Vertebral Fracture * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Tibia Fracture * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Toxicity to Various Agents * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Traumatic Haematoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Traumatic Haemothorax * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Traumatic Intracranial Haematoma * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Traumatic Lung Injury * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Upper Limb Fracture * 1  1/16709 (0.01%)  1 2/8367 (0.02%)  2
Wound Dehiscence * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Wrist Fracture * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Investigations     
Body Temperature Increased * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Cardiac Murmur * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Computerised Tomogram Thorax Abnormal * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Electrocardiogram Abnormal * 1  1/16709 (0.01%)  2 0/8367 (0.00%)  0
Heart Rate Increased * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Human Metapneumovirus Test Positive * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Sars-Cov-2 Test Positive * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Metabolism and nutrition disorders     
Decreased Appetite * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Dehydration * 1  5/16709 (0.03%)  6 1/8367 (0.01%)  1
Diabetes Mellitus * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Diabetes Mellitus Inadequate Control * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Diabetic Ketoacidosis * 1  4/16709 (0.02%)  4 3/8367 (0.04%)  4
Electrolyte Imbalance * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Failure to Thrive * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Gout * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Hyperglycaemia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hypoglycaemia * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Hypokalaemia * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Hyponatraemia * 1  3/16709 (0.02%)  3 2/8367 (0.02%)  2
Hypovolaemia * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Lactic Acidosis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Type 2 Diabetes Mellitus * 1  1/16709 (0.01%)  1 3/8367 (0.04%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/16709 (0.01%)  1 3/8367 (0.04%)  3
Arthritis * 1  3/16709 (0.02%)  3 1/8367 (0.01%)  1
Arthropathy * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Back Pain * 1  4/16709 (0.02%)  4 1/8367 (0.01%)  1
Cervical Spinal Stenosis * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Inclusion Body Myositis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Intervertebral Disc Degeneration * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Intervertebral Disc Protrusion * 1  4/16709 (0.02%)  4 0/8367 (0.00%)  0
Joint Effusion * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Lumbar Spinal Stenosis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Musculoskeletal Pain * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Osteoarthritis * 1  16/16709 (0.10%)  16 13/8367 (0.16%)  14
Osteonecrosis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Osteoporotic Fracture * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Polymyalgia Rheumatica * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Rheumatoid Arthritis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Rotator Cuff Syndrome * 1  3/16709 (0.02%)  3 2/8367 (0.02%)  2
Scoliosis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Soft Tissue Necrosis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Spinal Osteoarthritis * 1  0/16709 (0.00%)  0 2/8367 (0.02%)  2
Spinal Stenosis * 1  1/16709 (0.01%)  1 4/8367 (0.05%)  4
Spondylolisthesis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Vertebral Foraminal Stenosis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Myeloid Leukaemia * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Acute Promyelocytic Leukaemia * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Adenocarcinoma * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Adenocarcinoma of Colon * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
B-Cell Lymphoma * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Basal Cell Carcinoma * 1  1/16709 (0.01%)  1 2/8367 (0.02%)  3
Benign Renal Neoplasm * 1  1/16709 (0.01%)  2 0/8367 (0.00%)  0
Bile Duct Cancer * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Bladder Cancer * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Bladder Squamous Cell Carcinoma Stage Iv * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Bowen's Disease * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Brain Neoplasm * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Brain Neoplasm Malignant * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Brain Stem Glioma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Breast Cancer * 1  11/16709 (0.07%)  11 2/8367 (0.02%)  2
Breast Cancer Stage Ii * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Cancer Pain * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Cerebral Haemangioma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Cervix Carcinoma * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Cholangiocarcinoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Chronic Lymphocytic Leukaemia * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Colon Cancer * 1  3/16709 (0.02%)  3 3/8367 (0.04%)  3
Colon Cancer Stage I * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Colorectal Cancer * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Desmoplastic Melanoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Diffuse Large B-Cell Lymphoma * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Endometrial Adenocarcinoma * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Endometrial Cancer * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Endometrial Cancer Stage I * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Endometrial Cancer Stage Ii * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Gastric Cancer * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Glioma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hepatic Cancer * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hepatic Cancer Stage Iv * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Hepatocellular Carcinoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hodgkin's Disease * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Intestinal Metastasis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Intraductal Proliferative Breast Lesion * 1  2/16709 (0.01%)  3 0/8367 (0.00%)  0
Invasive Breast Carcinoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Invasive Ductal Breast Carcinoma * 1  3/16709 (0.02%)  3 1/8367 (0.01%)  2
Invasive Lobular Breast Carcinoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Keratoacanthoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Large Intestine Benign Neoplasm * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Laryngeal Squamous Cell Carcinoma * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Lung Adenocarcinoma * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Lung Carcinoma Cell Type Unspecified Stage I * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Lung Carcinoma Cell Type Unspecified Stage Iii * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Lung Neoplasm Malignant * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Lymphocytic Leukaemia * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Malignant Melanoma * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Malignant Melanoma Stage Iii * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Malignant Melanoma in Situ * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Metastatic Gastric Cancer * 1  1/16709 (0.01%)  4 0/8367 (0.00%)  0
Metastatic Malignant Melanoma * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Metastatic Renal Cell Carcinoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Metastatic Squamous Cell Carcinoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Mucinous Breast Carcinoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Myelodysplastic Syndrome * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Neoplasm Malignant * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Non-Hodgkin's Lymphoma * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Non-Small Cell Lung Cancer Stage Iv * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Oesophageal Carcinoma * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Pancreatic Carcinoma * 1  1/16709 (0.01%)  1 3/8367 (0.04%)  3
Pancreatic Carcinoma Metastatic * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Pancreatic Carcinoma Stage Iv * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Pituitary Tumour Benign * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Plasma Cell Myeloma * 1  0/16709 (0.00%)  0 3/8367 (0.04%)  3
Pleomorphic Adenoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Polycythaemia Vera * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Prostate Cancer * 1  18/16709 (0.11%)  18 4/8367 (0.05%)  4
Prostate Cancer Metastatic * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Rectal Adenocarcinoma * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Rectal Cancer Stage Iv * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Renal Cancer * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Renal Cell Carcinoma * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Skin Cancer * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Small Cell Lung Cancer * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Small Cell Lung Cancer Metastatic * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Small Intestine Adenocarcinoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Squamous Cell Carcinoma of Lung * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Tongue Neoplasm Malignant Stage Unspecified * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Tonsil Cancer * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Urethral Cancer * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Uterine Cancer * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Vaginal Cancer * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Nervous system disorders     
Aphasia * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Balance Disorder * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Basal Ganglia Haemorrhage * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Bell's Palsy * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Brain Injury * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Carotid Artery Disease * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Carotid Artery Stenosis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  2
Cerebellar Stroke * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Cerebral Haemorrhage * 1  2/16709 (0.01%)  2 2/8367 (0.02%)  2
Cerebral Infarction * 1  9/16709 (0.05%)  9 3/8367 (0.04%)  3
Cerebral Mass Effect * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Cerebral Venous Sinus Thrombosis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Cerebrospinal Fluid Leakage * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Cerebrovascular Accident * 1  20/16709 (0.12%)  20 8/8367 (0.10%)  8
Cerebrovascular Disorder * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Cervical Radiculopathy * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Dementia * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Diabetic Neuropathy * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Dizziness Postural * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Embolic Stroke * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Encephalopathy * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Epilepsy * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Generalised Tonic-Clonic Seizure * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Haemorrhage Intracranial * 1  0/16709 (0.00%)  0 2/8367 (0.02%)  2
Haemorrhagic Stroke * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Hemiparesis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hepatic Encephalopathy * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Intracranial Aneurysm * 1  0/16709 (0.00%)  0 2/8367 (0.02%)  3
Intracranial Mass * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Ischaemic Stroke * 1  7/16709 (0.04%)  7 7/8367 (0.08%)  7
Lacunar Infarction * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Lacunar Stroke * 1  0/16709 (0.00%)  0 2/8367 (0.02%)  2
Loss of Consciousness * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Lumbar Radiculopathy * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Lumbosacral Radiculopathy * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Monoplegia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Myasthenia Gravis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Myasthenic Syndrome * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Myelopathy * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Nerve Compression * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Neuropathy Peripheral * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Ophthalmic Migraine * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Paraesthesia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Parkinson's Disease * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Partial Seizures * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Presyncope * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Progressive Supranuclear Palsy * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Radiculopathy * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Seizure * 1  1/16709 (0.01%)  1 3/8367 (0.04%)  4
Spinal Claudication * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Subarachnoid Haemorrhage * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Syncope * 1  7/16709 (0.04%)  7 7/8367 (0.08%)  7
Toxic Encephalopathy * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Transient Global Amnesia * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Transient Ischaemic Attack * 1  15/16709 (0.09%)  15 11/8367 (0.13%)  11
Trigeminal Neuralgia * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Vascular Dementia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Vertigo CNS Origin * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Product Issues     
Device Dislocation * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Device Loosening * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Device Malfunction * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Device Pacing Issue * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Psychiatric disorders     
Completed Suicide * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Confusional State * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Depression * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Drug Abuse * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Major Depression * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Mental Status Changes * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Neurosis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Suicidal Ideation * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Renal and urinary disorders     
Acute Kidney Injury * 1  7/16709 (0.04%)  7 5/8367 (0.06%)  5
Chronic Kidney Disease * 1  2/16709 (0.01%)  2 2/8367 (0.02%)  2
End Stage Renal Disease * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Hydronephrosis * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Nephritic Syndrome * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Nephrolithiasis * 1  4/16709 (0.02%)  4 4/8367 (0.05%)  4
Prerenal Failure * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Renal Colic * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Renal Failure * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  2
Renal Haemorrhage * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Renal Injury * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Renal Mass * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Ureterolithiasis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Urethral Caruncle * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Urinary Incontinence * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Urinary Retention * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Urinary Tract Disorder * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia * 1  3/16709 (0.02%)  3 4/8367 (0.05%)  5
Ovarian Cyst * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Uterine Prolapse * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Uterovaginal Prolapse * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Respiratory, thoracic and mediastinal disorders     
Acute Pulmonary Oedema * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Acute Respiratory Distress Syndrome * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Acute Respiratory Failure * 1  18/16709 (0.11%)  19 7/8367 (0.08%)  7
Asthma * 1  4/16709 (0.02%)  4 5/8367 (0.06%)  6
Bronchitis Chronic * 1  3/16709 (0.02%)  4 1/8367 (0.01%)  1
Chronic Obstructive Pulmonary Disease * 1  31/16709 (0.19%)  33 14/8367 (0.17%)  14
Cough * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Cystic Lung Disease * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Dyspnoea * 1  6/16709 (0.04%)  6 3/8367 (0.04%)  3
Emphysema * 1  4/16709 (0.02%)  4 2/8367 (0.02%)  2
Epistaxis * 1  1/16709 (0.01%)  2 0/8367 (0.00%)  0
Haemothorax * 1  2/16709 (0.01%)  3 0/8367 (0.00%)  0
Hydrothorax * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hypoxia * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Interstitial Lung Disease * 1  1/16709 (0.01%)  1 2/8367 (0.02%)  2
Pharyngeal Mass * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Pleural Effusion * 1  5/16709 (0.03%)  5 0/8367 (0.00%)  0
Pleuritic Pain * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pneumomediastinum * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pneumonitis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pneumothorax * 1  4/16709 (0.02%)  5 5/8367 (0.06%)  5
Pneumothorax Spontaneous * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Pulmonary Embolism * 1  29/16709 (0.17%)  29 9/8367 (0.11%)  9
Pulmonary Haemorrhage * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Pulmonary Hypertension * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Pulmonary Mass * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Pulmonary Oedema * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Pulmonary Thrombosis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Respiratory Failure * 1  5/16709 (0.03%)  5 2/8367 (0.02%)  2
Sinus Disorder * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Sleep Apnoea Syndrome * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Skin and subcutaneous tissue disorders     
Decubitus Ulcer * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Diabetic Foot * 1  1/16709 (0.01%)  2 2/8367 (0.02%)  3
Hyperkeratosis * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
Social circumstances     
Loss of Personal Independence in Daily Activities * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Surgical and medical procedures     
Hospitalisation * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Vascular disorders     
Aortic Aneurysm * 1  4/16709 (0.02%)  5 1/8367 (0.01%)  1
Aortic Dissection * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Aortic Stenosis * 1  2/16709 (0.01%)  2 1/8367 (0.01%)  1
Arterial Occlusive Disease * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Arteriosclerosis * 1  3/16709 (0.02%)  3 0/8367 (0.00%)  0
Deep Vein Thrombosis * 1  15/16709 (0.09%)  17 3/8367 (0.04%)  3
Extravasation Blood * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Haematoma * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hypertension * 1  6/16709 (0.04%)  6 0/8367 (0.00%)  0
Hypertensive Crisis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hypertensive Emergency * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Hypertensive Urgency * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Hypotension * 1  5/16709 (0.03%)  5 2/8367 (0.02%)  2
Orthostatic Hypotension * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Peripheral Arterial Occlusive Disease * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Peripheral Artery Aneurysm * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Peripheral Artery Stenosis * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Peripheral Artery Thrombosis * 1  2/16709 (0.01%)  2 0/8367 (0.00%)  0
Peripheral Ischaemia * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Peripheral Vascular Disorder * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Shock * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Shock Haemorrhagic * 1  1/16709 (0.01%)  1 1/8367 (0.01%)  1
Thrombophlebitis * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
Venous Thrombosis Limb * 1  0/16709 (0.00%)  0 1/8367 (0.01%)  1
White Coat Hypertension * 1  1/16709 (0.01%)  1 0/8367 (0.00%)  0
1
Term from vocabulary, MedDRA 25.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1477/2330 (63.39%)      408/1165 (35.02%)    
Gastrointestinal disorders     
Nausea(Solicited) * 1  324/2330 (13.91%)  324 75/1165 (6.44%)  75
General disorders     
Fatigue(Solicited) * 1  789/2330 (33.86%)  789 165/1165 (14.16%)  165
Pain * 1  48/2330 (2.06%)  61 12/1165 (1.03%)  18
Pyrexia(Solicited) * 1  171/2330 (7.34%)  171 5/1165 (0.43%)  5
Vaccination Site Erythema(Solicited) * 1  63/2330 (2.70%)  63 5/1165 (0.43%)  5
Vaccination Site Pain(Solicited) * 1  1065/2330 (45.71%)  1065 168/1165 (14.42%)  168
Vaccination Site Swelling(Solicited) * 1  68/2330 (2.92%)  68 3/1165 (0.26%)  3
Investigations     
Blood Pressure Diastolic Increased * 1  58/2330 (2.49%)  58 21/1165 (1.80%)  21
Blood Pressure Systolic Increased * 1  150/2330 (6.44%)  150 60/1165 (5.15%)  60
Respiratory Rate Increased * 1  89/2330 (3.82%)  89 49/1165 (4.21%)  49
Musculoskeletal and connective tissue disorders     
Myalgia(Solicited) * 1  614/2330 (26.35%)  614 119/1165 (10.21%)  119
Nervous system disorders     
Headache(Solicited) * 1  597/2330 (25.62%)  597 128/1165 (10.99%)  128
Respiratory, thoracic and mediastinal disorders     
Cough * 1  68/2330 (2.92%)  74 25/1165 (2.15%)  26
1
Term from vocabulary, MedDRA 25.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Franchise Leader
Organization: Janssen Vaccines & Prevention B.V.
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT04908683    
Other Study ID Numbers: CR108959
2020-005458-97 ( EudraCT Number )
VAC18193RSV3001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Submitted: May 27, 2021
First Posted: June 1, 2021
Results First Submitted: December 21, 2023
Results First Posted: February 8, 2024
Last Update Posted: February 8, 2024