Trial Outcomes & Findings for A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection (NCT NCT05070546)
NCT ID: NCT05070546
Last Updated: 2025-05-25
Results Overview
Number of participants with solicited local AEs at 7 days post-vaccination in Cohorts 1 and 2 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 predefined local events (at the injection site: erythema, pain/tenderness and swelling) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1124 participants
Primary outcome timeframe
7 days after vaccination on Day 1 (Day 8)
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
320
|
68
|
320
|
70
|
316
|
30
|
|
Overall Study
Vaccinated
|
319
|
68
|
319
|
69
|
313
|
30
|
|
Overall Study
COMPLETED
|
310
|
65
|
309
|
68
|
308
|
29
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
11
|
2
|
8
|
1
|
Reasons for withdrawal
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
2
|
7
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Overall Study
Randomized but not vaccinated
|
1
|
0
|
1
|
1
|
3
|
0
|
Baseline Characteristics
A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
Baseline characteristics by cohort
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
n=319 Participants
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
n=68 Participants
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
n=319 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
n=69 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
n=313 Participants
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
n=30 Participants
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
Total
n=1118 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 12.33 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 12.34 • n=7 Participants
|
44.4 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 11.58 • n=4 Participants
|
71.1 years
STANDARD_DEVIATION 4.74 • n=21 Participants
|
71.2 years
STANDARD_DEVIATION 5.1 • n=10 Participants
|
50.6 years
STANDARD_DEVIATION 17.27 • n=115 Participants
|
|
Age, Customized
Adults (18-64 years)
|
319 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
775 Participants
n=115 Participants
|
|
Age, Customized
From 65 and over
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
313 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
343 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
193 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
648 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
132 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
470 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
122 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
274 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
289 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
984 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
289 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
303 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
1061 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
BELGIUM
|
178 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
278 Participants
n=115 Participants
|
|
Region of Enrollment
GERMANY
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
312 Participants
n=115 Participants
|
|
Region of Enrollment
SPAIN
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Region of Enrollment
SWEDEN
|
33 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
277 Participants
n=115 Participants
|
|
Region of Enrollment
UNITED STATES
|
108 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
231 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 7 days after vaccination on Day 1 (Day 8)Population: Full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). Here 'N' (number of participants analysed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified cohorts only.
Number of participants with solicited local AEs at 7 days post-vaccination in Cohorts 1 and 2 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 predefined local events (at the injection site: erythema, pain/tenderness and swelling) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.
Outcome measures
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
n=316 Participants
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
n=68 Participants
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
n=318 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
n=68 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs)
|
273 Participants
|
10 Participants
|
276 Participants
|
15 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days after vaccination on Day 1 (Day 8)Population: FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). Here 'N' (number of participants analysed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified cohorts only.
Number of participants with solicited systemic AEs at 7 days post-vaccination in Cohorts 1 and 2 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 AEs including pyrexia, headache, fatigue, myalgia and nausea were collected within 7 days after vaccination.
Outcome measures
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
n=316 Participants
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
n=68 Participants
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
n=318 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
n=68 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs
|
277 Participants
|
33 Participants
|
275 Participants
|
40 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days after vaccination on Day 1 (Day 29)Population: FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). This outcome measure was planned to be analysed for specified cohorts only.
Number of participants with unsolicited AEs post-vaccination in Cohorts 1 and 2 were reported. An AE was defined as any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were defined as all AEs for which the participant was not specifically questioned in the participant diary.
Outcome measures
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
n=319 Participants
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
n=68 Participants
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
n=319 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
n=69 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Unsolicited AEs
|
111 Participants
|
13 Participants
|
85 Participants
|
12 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 months after vaccination on Day 1 (Day 183)Population: FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
Number of participants with SAEs post-vaccination were reported. An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
n=319 Participants
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
n=68 Participants
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
n=319 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
n=69 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
n=313 Participants
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
n=30 Participants
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs)
|
1 Participants
|
1 Participants
|
10 Participants
|
0 Participants
|
13 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 months after vaccination on Day 1 (Day 183)Population: FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
Number of participants with AESI post-vaccination 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. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.
Outcome measures
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
n=319 Participants
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
n=68 Participants
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
n=319 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
n=69 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
n=313 Participants
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
n=30 Participants
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 14 days after vaccination on Day 1 (Day 15)Population: The Per-protocol Immunogenicity (PPI) set included all randomised participants on Day 15 who received study vaccine and for whom immunogenicity data were available. Here 'N' (number of participants analysed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified arms only. As planned, combined data of participants aged 18-59 years Cohorts 1 (Group 1) and 2 (Group 3) has been reported.
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay and were expressed as 50% inhibitory concentration (IC50) units.
Outcome measures
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
n=301 Participants
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
n=290 Participants
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
n=602 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers
|
7095 Titers
Interval 6261.0 to 8042.0
|
4596 Titers
Interval 4059.0 to 5204.0
|
6491 Titers
Interval 5847.0 to 7206.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days after vaccination on Day 1 (Day 15)Population: PPI set included all randomized participants who received study vaccine and for whom immunogenicity data were available. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified arms only. As planned, combined data of participants aged 18-59 years Cohorts 1 (Group 1) and 2 (Group 3) has been reported.
Percentage of participants with seroresponse as assessed by VNA-A2 strain were reported. Seroresponse was defined as a 4-fold increase from baseline in Day 15 VNA A2 antibody titers.
Outcome measures
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
n=300 Participants
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
n=290 Participants
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
n=602 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2)
|
88 percentage of participants
|
82.41 percentage of participants
|
89.37 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days after vaccination on Day 1 (Day 15)Population: PPI set included all randomised participants who received study vaccine and for whom immunogenicity data were available.
GMTs of RSV Fusion Protein (PreF) antibodies as assessed by ELISA-Pre-Fusion at Day 15 were reported.
Outcome measures
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
n=302 Participants
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
n=64 Participants
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
n=301 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
n=61 Participants
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
n=290 Participants
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
n=29 Participants
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion
|
4662 ELISA units per liter (EU/L)
Interval 4350.0 to 4997.0
|
246 ELISA units per liter (EU/L)
Interval 214.0 to 284.0
|
5175 ELISA units per liter (EU/L)
Interval 4808.0 to 5569.0
|
283 ELISA units per liter (EU/L)
Interval 246.0 to 326.0
|
3864 ELISA units per liter (EU/L)
Interval 3559.0 to 4196.0
|
240 ELISA units per liter (EU/L)
Interval 203.0 to 285.0
|
Adverse Events
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Serious events: 1 serious events
Other events: 77 other events
Deaths: 0 deaths
Group 2 (Cohort 1): Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
Serious events: 10 serious events
Other events: 50 other events
Deaths: 0 deaths
Group 4 (Cohort 2): Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Serious events: 13 serious events
Other events: 32 other events
Deaths: 0 deaths
Group 6 (Cohort 3): Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
n=319 participants at risk
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
n=68 participants at risk
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
n=319 participants at risk
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
n=69 participants at risk
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
n=313 participants at risk
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
n=30 participants at risk
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
3.3%
1/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
3.3%
1/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Infections and infestations
Haemorrhagic Fever with Renal Syndrome
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Infections and infestations
Mastitis
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
1.5%
1/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Infections and infestations
Meningitis Aseptic
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer Stage 0, with Cancer in Situ
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Her2 Positive Breast Cancer
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Nervous system disorders
Facial Paresis
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Nervous system disorders
Syncope
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Reproductive system and breast disorders
Testicular Torsion
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.64%
2/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Vascular disorders
Haematoma
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
Other adverse events
| Measure |
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
n=319 participants at risk
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture 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) on Day 1.
|
Group 2 (Cohort 1): Placebo
n=68 participants at risk
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
n=319 participants at risk
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 4 (Cohort 2): Placebo
n=69 participants at risk
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
|
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
n=313 participants at risk
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1.
|
Group 6 (Cohort 3): Placebo
n=30 participants at risk
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
3.3%
1/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.63%
2/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
1.5%
1/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.63%
2/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.64%
2/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
3.3%
1/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
8/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.63%
2/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.64%
2/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
General disorders
Chills
|
18.8%
60/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
1.5%
1/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
9.7%
31/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
1.4%
1/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
4.8%
15/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Infections and infestations
Covid-19
|
2.5%
8/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
1.5%
1/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
1.3%
4/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
4.3%
3/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.64%
2/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
3.3%
1/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
2.8%
9/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
4.3%
3/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
2.9%
9/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
3.3%
1/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Infections and infestations
Sinusitis
|
2.2%
7/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
3.3%
1/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.94%
3/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
4.3%
3/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.32%
1/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
3.3%
1/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
3.3%
1/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Nervous system disorders
Headache
|
1.3%
4/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
5.9%
4/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.63%
2/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.64%
2/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
2.5%
8/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/68 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.31%
1/319 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/69 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/313 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
0.00%
0/30 • Up to Day 183
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
|
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