Trial Outcomes & Findings for A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years (NCT NCT05101486)
NCT ID: NCT05101486
Last Updated: 2025-05-25
Results Overview
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
755 participants
Primary outcome timeframe
14 days post vaccination on Day 1 (Day 15)
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1.
|
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
Participants received Ad26.RSV.preF 2.5\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
Participants received Ad26.RSV.preF 1.0\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
251
|
252
|
252
|
|
Overall Study
Vaccinated (Full Analysis Set [FAS])
|
250
|
251
|
251
|
|
Overall Study
COMPLETED
|
231
|
241
|
228
|
|
Overall Study
NOT COMPLETED
|
20
|
11
|
24
|
Reasons for withdrawal
| Measure |
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1.
|
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
Participants received Ad26.RSV.preF 2.5\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
Participants received Ad26.RSV.preF 1.0\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
12
|
8
|
17
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
4
|
|
Overall Study
Randomized but not vaccinated
|
1
|
1
|
1
|
Baseline Characteristics
A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
Baseline characteristics by cohort
| Measure |
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=250 Participants
Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1.
|
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
n=251 Participants
Participants received Ad26.RSV.preF 2.5\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
n=251 Participants
Participants received Ad26.RSV.preF 1.0\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Total
n=752 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 4.37 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 4.42 • n=7 Participants
|
65.5 years
STANDARD_DEVIATION 4.27 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 4.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
416 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
336 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
150 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
438 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
308 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
209 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
622 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED STATES
|
250 Participants
n=5 Participants
|
251 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
752 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 days post vaccination on Day 1 (Day 15)Population: The per-protocol immunogenicity (PPI) set included all randomized participants who received the study vaccine, and for whom immunogenicity data were available.
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=236 Participants
Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1.
|
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
n=241 Participants
Participants received Ad26.RSV.preF 2.5\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
n=233 Participants
Participants received Ad26.RSV.preF 1.0\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
|
4277 ELISA units per liter (EU/L)
Interval 3891.0 to 4701.0
|
4121 ELISA units per liter (EU/L)
Interval 3722.0 to 4562.0
|
4602 ELISA units per liter (EU/L)
Interval 4154.0 to 5099.0
|
SECONDARY outcome
Timeframe: 14 days post vaccination on Day 1 (Day 15)Population: The PPI set included all randomized participants who received the study vaccine, and for whom immunogenicity data were available.
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay at 14 days post administration of Ad26/protein preF RSV-based vaccine were expressed as 50 percent (%) inhibitory concentration (IC50) units.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=236 Participants
Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1.
|
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
n=241 Participants
Participants received Ad26.RSV.preF 2.5\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
n=233 Participants
Participants received Ad26.RSV.preF 1.0\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
|---|---|---|---|
|
Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination
|
6516 Titers
Interval 5834.0 to 7278.0
|
5538 Titers
Interval 4937.0 to 6212.0
|
6846 Titers
Interval 6035.0 to 7766.0
|
SECONDARY outcome
Timeframe: Up to Day 7 post vaccination on Day 1 (up to Day 8)Population: The full analysis set (FAS) included all participants who received study vaccination, regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Number of participants with solicited local AEs 7 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=243 Participants
Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1.
|
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
n=248 Participants
Participants received Ad26.RSV.preF 2.5\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
n=247 Participants
Participants received Ad26.RSV.preF 1.0\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination
|
119 Participants
|
103 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: Up to Day 7 post vaccination on Day 1 (up to Day 8)Population: The FAS included all participants who received study vaccination, regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Number of participants with solicited systemic AEs 7 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events include events such as fatigue, headache, nausea, myalgia, and 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).
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=243 Participants
Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1.
|
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
n=248 Participants
Participants received Ad26.RSV.preF 2.5\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
n=247 Participants
Participants received Ad26.RSV.preF 1.0\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination
|
101 Participants
|
86 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days post vaccination on Day 1 (up to Day 29)Population: The FAS included all participants who received study vaccination, regardless of the occurrence of protocol deviations.
Number of participants with unsolicited AEs 28 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=250 Participants
Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1.
|
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
n=251 Participants
Participants received Ad26.RSV.preF 2.5\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
n=251 Participants
Participants received Ad26.RSV.preF 1.0\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
|---|---|---|---|
|
Number of Participants With Unsolicited AEs for 28 Days Post Vaccination
|
22 Participants
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)Population: The FAS included all participants who received study vaccination, regardless of the occurrence of protocol deviations.
Number of participants with SAEs until 6 months post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=250 Participants
Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1.
|
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
n=251 Participants
Participants received Ad26.RSV.preF 2.5\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
n=251 Participants
Participants received Ad26.RSV.preF 1.0\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination
|
5 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)Population: The FAS included all participants who received study vaccination, regardless of the occurrence of protocol deviations.
Number of participants with AESIs until 6 months post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=250 Participants
Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1.
|
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
n=251 Participants
Participants received Ad26.RSV.preF 2.5\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
n=251 Participants
Participants received Ad26.RSV.preF 1.0\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
|---|---|---|---|
|
Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=250 participants at risk
Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1.
|
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg
n=251 participants at risk
Participants received Ad26.RSV.preF 2.5\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
n=251 participants at risk
Participants received Ad26.RSV.preF 1.0\*10\^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.40%
1/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Death
|
0.40%
1/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Drug Withdrawal Syndrome
|
0.40%
1/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Cellulitis
|
0.40%
1/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Covid-19
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Pneumonia
|
0.80%
2/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.40%
1/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.40%
1/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.40%
1/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Stage Iv
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Focal Dyscognitive Seizures
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Peroneal Nerve Palsy
|
0.40%
1/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Psychiatric disorders
Alcohol Abuse
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/250 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.40%
1/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/251 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
Other adverse events
Adverse event data not reported
Additional Information
Director Biomarkers Viral Vaccines
Janssen Vaccines & Prevention B.V.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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 to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER