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Trial record 1 of 1 for:    VAC18193RSV2001
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A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older (CYPRESS)

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ClinicalTrials.gov Identifier: NCT03982199
Recruitment Status : Completed
First Posted : June 11, 2019
Results First Posted : July 24, 2023
Last Update Posted : July 24, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Respiratory Syncytial Viruses
Respiratory Tract Diseases
Interventions Biological: RSV Vaccine
Biological: Placebo
Enrollment 5815
Recruitment Details A total of 5815 participants were enrolled and randomized in the study, of which 5782 participants were vaccinated.
Pre-assignment Details  
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) Group 2: Placebo
Hide Arm/Group Description Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Adult participants aged greater than or equal to (>=) 65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 2 and Year 3, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture).
Period Title: Overall Study
Started 2909 2906
Vaccinated (Full Analysis Set [FAS]) 2891 2891
Completed 1308 1260
Not Completed 1601 1646
Reason Not Completed
Site terminated by sponsor             14             17
Lost to Follow-up             137             142
Physician Decision             38             33
Withdrawal by Subject             514             496
Adverse Event             10             14
Technical Problems             9             8
Death             40             40
Study terminated by sponsor             2             1
Other             76             81
Ongoing             743             799
Randomized but not vaccinated             18             15
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) Group 2: Placebo Total
Hide Arm/Group Description Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Adult participants aged greater than or equal to (>=) 65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 2 and Year 3, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Total of all reporting groups
Overall Number of Baseline Participants 2891 2891 5782
Hide Baseline Analysis Population Description
The Full Analysis Set (FAS) included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2891 participants 2891 participants 5782 participants
71.7  (5.37) 71.6  (5.38) 71.7  (5.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2891 participants 2891 participants 5782 participants
Female
1639
  56.7%
1694
  58.6%
3333
  57.6%
Male
1252
  43.3%
1197
  41.4%
2449
  42.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2891 participants 2891 participants 5782 participants
Hispanic or Latino
85
   2.9%
97
   3.4%
182
   3.1%
Not Hispanic or Latino
2778
  96.1%
2773
  95.9%
5551
  96.0%
Unknown or Not Reported
28
   1.0%
21
   0.7%
49
   0.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2891 participants 2891 participants 5782 participants
American Indian or Alaska Native
8
   0.3%
9
   0.3%
17
   0.3%
Asian
15
   0.5%
17
   0.6%
32
   0.6%
Native Hawaiian or Other Pacific Islander
16
   0.6%
5
   0.2%
21
   0.4%
Black or African American
169
   5.8%
148
   5.1%
317
   5.5%
White
2658
  91.9%
2690
  93.0%
5348
  92.5%
More than one race
9
   0.3%
14
   0.5%
23
   0.4%
Unknown or Not Reported
16
   0.6%
8
   0.3%
24
   0.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
UNITED STATES Number Analyzed 2891 participants 2891 participants 5782 participants
2891
 100.0%
2891
 100.0%
5782
 100.0%
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 case definition-1, 2 and 3 were reported. Case definition 1 was defined as having a new onset or worsening in 3 or more symptoms of lower respiratory tract infection (LRTI) ; Case definition 2 was defined as having a new onset or worsening in greater than or equal to (>=) 2 symptoms of LRTI; and Case definition 3 was defined as having a new onset or worsening in >=2 OR >=1 symptoms of LRTI with >=1 systemic symptoms. Systemic symptoms (fatigue/malaise and fever/feverishness) and symptoms of LRTI (cough, shortness of breath, sputum production, wheezing and tachypnea) were collected via the RiiQ. 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 LRTD symptom scores.
Time Frame From screening up to 2 years 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-protocol Efficacy (PPE) population included all randomized and vaccinated participants excluding participants with major protocol deviations expecting to impact the efficacy outcomes. Any participant with an RT-PCR-confirmed RSV-mediated ARI with 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 (Protein Mixture) Group 2: Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1.
Adult participants aged greater than or equal to (>=) 65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 2 and Year 3, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture).
Overall Number of Participants Analyzed 2791 2801
Measure Type: Count of Participants
Unit of Measure: Participants
Case Definition-1
6
   0.2%
30
   1.1%
Case Definition-2
10
   0.4%
40
   1.4%
Case Definition-3
13
   0.5%
43
   1.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture), Group 2: Placebo
Comments Case Definition 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00004
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Event Rate
Estimated Value 80.0
Confidence Interval (2-Sided) 94.211%
52.2 to 92.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture), Group 2: Placebo
Comments Case Definition 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00001
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Event Rate
Estimated Value 75.0
Confidence Interval (2-Sided) 94.211%
50.1 to 88.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture), Group 2: Placebo
Comments Case Definition 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00004
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Event Rate
Estimated Value 69.8
Confidence Interval (2-Sided) 94.211%
43.7 to 84.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Any RT-PCR-confirmed RSV Disease
Hide Description [Not Specified]
Time Frame From screening up to end of the study (up to 3 years 9 months)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title RSV A2 Strain Neutralization Antibody Titers
Hide Description [Not Specified]
Time Frame From screening up to end of the study (up to 3 years 9 months)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Pre-Fusion Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
Hide Description [Not Specified]
Time Frame From screening up to end of the study (up to 3 years 9 months)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Post-Fusion IgG Serum Antibody Response as Assessed by ELISA
Hide Description [Not Specified]
Time Frame From screening up to end of the study (up to 3 years 9 months)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
Hide Description [Not Specified]
Time Frame From screening up to end of the study (up to 3 years 9 months)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After First Vaccination
Hide Description 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/induration, and pain/tenderness. Per protocol, all solicited local AEs were considered as related to intervention.
Time Frame Up to Day 8 (7 days after first vaccination on Day 1)
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 and unsolicited AEs for 28 days after vaccination). Here, 'N' (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 (Protein Mixture) Group 2: Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1.
Adult participants aged greater than or equal to (>=) 65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 2 and Year 3, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture).
Overall Number of Participants Analyzed 341 334
Measure Type: Count of Participants
Unit of Measure: Participants
132
  38.7%
29
   8.7%
8.Secondary Outcome
Title Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination
Hide Description 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, arthralgia, and fever (defined as an endogenous elevation of body temperature >=38.0°C, as recorded in at least one measurement).
Time Frame Up to Day 8 (7 days after first vaccination on Day 1)
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 and unsolicited AEs for 28 days after vaccination). Here, 'N' (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 (Protein Mixture) Group 2: Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1.
Adult participants aged greater than or equal to (>=) 65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 2 and Year 3, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture).
Overall Number of Participants Analyzed 341 334
Measure Type: Count of Participants
Unit of Measure: Participants
143
  41.9%
58
  17.4%
9.Secondary Outcome
Title Number of Participants With Unsolicited AEs up to 28 Days After First Vaccination
Hide Description 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 is not specifically questioned in the participant diary.
Time Frame Up to Day 29 (28 days after first vaccination on Day 1)
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 and unsolicited AEs for 28 days after vaccination).
Arm/Group Title Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) Group 2: Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1.
Adult participants aged greater than or equal to (>=) 65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 2 and Year 3, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture).
Overall Number of Participants Analyzed 348 347
Measure Type: Count of Participants
Unit of Measure: Participants
58
  16.7%
50
  14.4%
10.Secondary Outcome
Title Number of Participants With Solicited Local AEs 7 Days After Re-vaccination at 1, 2 and 3 Years
Hide Description [Not Specified]
Time Frame 7 days after re-vaccination at 1, 2 and 3 years
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Number of Participants With Solicited Systemic AEs 7 Days After Re-vaccination at 1, 2 and 3 Years
Hide Description [Not Specified]
Time Frame 7 days after re-vaccination at 1, 2 and 3 years
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Number of Participants With Unsolicited AEs 28 Days After Re-vaccination at 1, 2 and 3 Years
Hide Description [Not Specified]
Time Frame 28 days after re-vaccination at 1, 2 and 3 years
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) During the RSV Season
Hide Description [Not Specified]
Time Frame From screening up to end of the study (up to 3 years 9 months)
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Number of Participants With Adverse Events of Special Interests (AESI) During the RSV Season
Hide Description [Not Specified]
Time Frame From screening up to end of the study (up to 3 years 9 months)
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Number of Participants With SAE During ARI Follow-up Period
Hide Description [Not Specified]
Time Frame Up to 2 years 9 months
Outcome Measure Data Not Reported
Time Frame From screening up to 2 years 9 months
Adverse Event Reporting Description All-cause mortality and SAEs analyzed based on FAS population which included all randomized participants with a documented vaccine administration, regardless of occurrence of protocol deviations. Other (not including serious) AEs as solicited and unsolicited AEs were collected and analyzed in 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 (Protein Mixture) Group 2: Placebo
Hide Arm/Group Description Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Adult participants aged greater than or equal to (>=) 65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 2 and Year 3, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture).
All-Cause Mortality
Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) Group 2: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   40/2891 (1.38%)   40/2891 (1.38%) 
Hide Serious Adverse Events
Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) Group 2: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   206/2891 (7.13%)   210/2891 (7.26%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Blood Loss Anaemia * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Splenic Infarction * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Cardiac disorders     
Acute Coronary Syndrome * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Acute Left Ventricular Failure * 1  1/2891 (0.03%)  2/2891 (0.07%) 
Acute Myocardial Infarction * 1  1/2891 (0.03%)  2/2891 (0.07%) 
Angina Unstable * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Aortic Valve Disease * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Aortic Valve Stenosis * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Arrhythmia * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Arteriosclerosis Coronary Artery * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Atrial Fibrillation * 1  10/2891 (0.35%)  4/2891 (0.14%) 
Atrial Flutter * 1  3/2891 (0.10%)  1/2891 (0.03%) 
Bradycardia * 1  1/2891 (0.03%)  2/2891 (0.07%) 
Cardiac Arrest * 1  2/2891 (0.07%)  3/2891 (0.10%) 
Cardiac Failure * 1  1/2891 (0.03%)  2/2891 (0.07%) 
Cardiac Failure Congestive * 1  8/2891 (0.28%)  3/2891 (0.10%) 
Cardiomyopathy * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Coronary Artery Compression * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Coronary Artery Disease * 1  2/2891 (0.07%)  5/2891 (0.17%) 
Ischaemic Cardiomyopathy * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Left Ventricular Failure * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Myocardial Infarction * 1  8/2891 (0.28%)  9/2891 (0.31%) 
Myocardial Ischaemia * 1  2/2891 (0.07%)  2/2891 (0.07%) 
Ventricular Tachycardia * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  0/2891 (0.00%)  2/2891 (0.07%) 
Endocrine disorders     
Hypothyroidism * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Inappropriate Antidiuretic Hormone Secretion * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Ascites * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Colitis * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Diarrhoea * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Duodenal Ulcer Haemorrhage * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Food Poisoning * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Gastric Perforation * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Gastrointestinal Haemorrhage * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Hiatus Hernia * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Inguinal Hernia * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Intestinal Obstruction * 1  3/2891 (0.10%)  0/2891 (0.00%) 
Intestinal Perforation * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Large Intestinal Obstruction * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Nausea * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Obstructive Pancreatitis * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Oesophageal Obstruction * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Oesophageal Perforation * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Oesophagitis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Pancreatic Cyst * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Pancreatic Mass * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Pancreatitis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Pancreatitis Acute * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Rectal Prolapse * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Small Intestinal Obstruction * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Upper Gastrointestinal Haemorrhage * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Vomiting * 1  1/2891 (0.03%)  0/2891 (0.00%) 
General disorders     
Adverse Drug Reaction * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Asthenia * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Chest Discomfort * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Chest Pain * 1  1/2891 (0.03%)  3/2891 (0.10%) 
Death * 1  7/2891 (0.24%)  5/2891 (0.17%) 
Drowning * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Generalised Oedema * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Multiple Organ Dysfunction Syndrome * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Non-Cardiac Chest Pain * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Hepatobiliary disorders     
Cholecystitis * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Cholelithiasis * 1  2/2891 (0.07%)  2/2891 (0.07%) 
Cirrhosis Alcoholic * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Infections and infestations     
Abscess Neck * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Alpha Haemolytic Streptococcal Infection * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Appendicitis * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Bronchitis * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Cellulitis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Clostridium Difficile Colitis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Covid-19 * 1  13/2891 (0.45%)  13/2891 (0.45%) 
Covid-19 Pneumonia * 1  13/2891 (0.45%)  16/2891 (0.55%) 
Cystitis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Device Related Infection * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Diabetic Foot Infection * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Diverticulitis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Gangrene * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Influenza * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Kidney Infection * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Meningitis Aseptic * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Osteomyelitis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Periorbital Cellulitis * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Pneumonia * 1  16/2891 (0.55%)  12/2891 (0.42%) 
Pneumonia Aspiration * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Pneumonia Bacterial * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Pneumonia Chlamydial * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Pneumonia Mycoplasmal * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Pneumonia Parainfluenzae Viral * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Pyelonephritis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Sepsis * 1  3/2891 (0.10%)  1/2891 (0.03%) 
Septic Shock * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Streptococcal Sepsis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Tonsillitis * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Urinary Tract Infection * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Injury, poisoning and procedural complications     
Ankle Fracture * 1  2/2891 (0.07%)  1/2891 (0.03%) 
Carbon Monoxide Poisoning * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Cervical Vertebral Fracture * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Craniocerebral Injury * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Environmental Exposure * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Extradural Haematoma * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Facial Bones Fracture * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Femoral Neck Fracture * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Femur Fracture * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Fracture Displacement * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Head Injury * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Hip Fracture * 1  3/2891 (0.10%)  1/2891 (0.03%) 
Humerus Fracture * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Hypobarism * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Lumbar Vertebral Fracture * 1  3/2891 (0.10%)  1/2891 (0.03%) 
Post Procedural Complication * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Road Traffic Accident * 1  0/2891 (0.00%)  2/2891 (0.07%) 
Scapula Fracture * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Skin Abrasion * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Spinal Compression Fracture * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Spinal Fracture * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Subdural Haematoma * 1  3/2891 (0.10%)  0/2891 (0.00%) 
Tibia Fracture * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Traumatic Fracture * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Upper Limb Fracture * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Wound Dehiscence * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Wrist Fracture * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Metabolism and nutrition disorders     
Adult Failure to Thrive * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Dehydration * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Diabetes Mellitus * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Diabetic Ketoacidosis * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Hyperglycaemia * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Hyperkalaemia * 1  1/2891 (0.03%)  2/2891 (0.07%) 
Hypoglycaemia * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Hyponatraemia * 1  1/2891 (0.03%)  2/2891 (0.07%) 
Hypovolaemia * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Type 2 Diabetes Mellitus * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/2891 (0.07%)  1/2891 (0.03%) 
Cervical Spinal Stenosis * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Chondrocalcinosis Pyrophosphate * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Intervertebral Disc Protrusion * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Kyphoscoliosis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Musculoskeletal Chest Pain * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Osteoarthritis * 1  7/2891 (0.24%)  7/2891 (0.24%) 
Rhabdomyolysis * 1  0/2891 (0.00%)  2/2891 (0.07%) 
Rotator Cuff Syndrome * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Spinal Stenosis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Abdominal Neoplasm * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Acute Myeloid Leukaemia * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Adenocarcinoma of Colon * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Bladder Cancer * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Bladder Transitional Cell Carcinoma * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Brain Neoplasm * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Breast Cancer * 1  1/2891 (0.03%)  3/2891 (0.10%) 
Cancer Pain * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Endometrial Adenocarcinoma * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Hepatic Cancer * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Hepatocellular Carcinoma * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Her2 Positive Breast Cancer * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Intraductal Proliferative Breast Lesion * 1  3/2891 (0.10%)  0/2891 (0.00%) 
Invasive Ductal Breast Carcinoma * 1  0/2891 (0.00%)  3/2891 (0.10%) 
Lung Adenocarcinoma * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Lung Carcinoma Cell Type Unspecified Stage Iii * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Lung Carcinoma Cell Type Unspecified Stage Iv * 1  0/2891 (0.00%)  2/2891 (0.07%) 
Lung Neoplasm Malignant * 1  3/2891 (0.10%)  1/2891 (0.03%) 
Marginal Zone Lymphoma * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Metastases to Liver * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Metastatic Malignant Melanoma * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Metastatic Squamous Cell Carcinoma * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Non-Hodgkin's Lymphoma * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Non-Small Cell Lung Cancer * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Oesophageal Carcinoma * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Ovarian Adenoma * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Ovarian Cancer * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Pancreatic Carcinoma * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Pancreatic Carcinoma Stage Iv * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Papillary Serous Endometrial Carcinoma * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Prostate Cancer * 1  3/2891 (0.10%)  4/2891 (0.14%) 
Prostate Cancer Metastatic * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Renal Cancer * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Renal Cell Carcinoma * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Small Cell Lung Cancer Extensive Stage * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Throat Cancer * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Transitional Cell Cancer of the Renal Pelvis and Ureter * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Transitional Cell Carcinoma * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Uterine Cancer * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Waldenstrom's Macroglobulinaemia * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Nervous system disorders     
Ataxia * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Autonomic Neuropathy * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Carotid Artery Stenosis * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Cerebral Haemorrhage * 1  2/2891 (0.07%)  1/2891 (0.03%) 
Cerebral Ischaemia * 1  2/2891 (0.07%)  1/2891 (0.03%) 
Cerebrovascular Accident * 1  3/2891 (0.10%)  2/2891 (0.07%) 
Encephalopathy * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Hypoaesthesia * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Intracranial Aneurysm * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Ischaemic Stroke * 1  3/2891 (0.10%)  1/2891 (0.03%) 
Lacunar Infarction * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Lumbar Radiculopathy * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Metabolic Encephalopathy * 1  0/2891 (0.00%)  2/2891 (0.07%) 
Myelopathy * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Peroneal Nerve Palsy * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Presyncope * 1  1/2891 (0.03%)  3/2891 (0.10%) 
Sciatica * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Seizure * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Subarachnoid Haemorrhage * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Syncope * 1  2/2891 (0.07%)  1/2891 (0.03%) 
Toxic Encephalopathy * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Transient Ischaemic Attack * 1  0/2891 (0.00%)  4/2891 (0.14%) 
Tremor * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Trigeminal Neuralgia * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Psychiatric disorders     
Alcoholism * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Anxiety * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Bipolar Disorder * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Depression Suicidal * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Major Depression * 1  0/2891 (0.00%)  2/2891 (0.07%) 
Mental Status Changes * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  3/2891 (0.10%)  2/2891 (0.07%) 
Chronic Kidney Disease * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Hydronephrosis * 1  0/2891 (0.00%)  2/2891 (0.07%) 
Nephrolithiasis * 1  2/2891 (0.07%)  1/2891 (0.03%) 
Neurogenic Bladder * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Renal Colic * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Renal Failure * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Renal Injury * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Ureterolithiasis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Postmenopausal Haemorrhage * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Prostatitis * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Acute Respiratory Failure * 1  7/2891 (0.24%)  6/2891 (0.21%) 
Asthma * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Chronic Obstructive Pulmonary Disease * 1  10/2891 (0.35%)  4/2891 (0.14%) 
Dyspnoea * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Hypoxia * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Pleural Effusion * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Pneumothorax * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Pulmonary Embolism * 1  3/2891 (0.10%)  5/2891 (0.17%) 
Pulmonary Fibrosis * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Pulmonary Haemorrhage * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Pulmonary Oedema * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Respiratory Failure * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Vascular disorders     
Aortic Aneurysm * 1  0/2891 (0.00%)  1/2891 (0.03%) 
Aortic Stenosis * 1  2/2891 (0.07%)  1/2891 (0.03%) 
Arteriosclerosis * 1  2/2891 (0.07%)  0/2891 (0.00%) 
Endothelial Dysfunction * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Hypertensive Urgency * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Hypotension * 1  1/2891 (0.03%)  1/2891 (0.03%) 
Peripheral Arterial Occlusive Disease * 1  1/2891 (0.03%)  0/2891 (0.00%) 
Peripheral Ischaemia * 1  0/2891 (0.00%)  1/2891 (0.03%) 
1
Term from vocabulary, MedDRA Version 21.1
*
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 (Protein Mixture) Group 2: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   21/348 (6.03%)   24/347 (6.92%) 
Infections and infestations     
Respiratory Tract Infection * 1  13/348 (3.74%)  14/347 (4.03%) 
Upper Respiratory Tract Infection * 1  8/348 (2.30%)  10/347 (2.88%) 
1
Term from vocabulary, MedDRA Version 21.1
*
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 with hold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical 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: NCT03982199    
Other Study ID Numbers: CR108634
VAC18193RSV2001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Submitted: June 10, 2019
First Posted: June 11, 2019
Results First Submitted: June 6, 2023
Results First Posted: July 24, 2023
Last Update Posted: July 24, 2023