Trial Outcomes & Findings for A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults (NCT NCT05091307)
NCT ID: NCT05091307
Last Updated: 2025-05-25
Results Overview
GMTs of HI antibodies were measured using hemagglutination inhibition (HAI) assay against each of four influenza vaccine strains (A/Victoria \[H1N1\], A/Cambodia \[H3N2\], B/Victoria \[B/Victoria\] and B/Phuket \[B/Yamagata\]). This outcome measure was planned to be analyzed for specified arms only. PPII=Per-protocol influenza immunogenicity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
861 participants
Primary outcome timeframe
28 days after vaccination with seasonal quadrivalent standard-dose influenza vaccine (Day 29)
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
382
|
386
|
47
|
46
|
|
Overall Study
Treated
|
382
|
384
|
47
|
46
|
|
Overall Study
COMPLETED
|
312
|
316
|
43
|
44
|
|
Overall Study
NOT COMPLETED
|
70
|
70
|
4
|
2
|
Reasons for withdrawal
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
33
|
33
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
16
|
16
|
0
|
1
|
|
Overall Study
Covid-19 Vaccine/Treatment
|
14
|
15
|
1
|
1
|
|
Overall Study
Initiated Prohibited Medication
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
4
|
4
|
0
|
0
|
|
Overall Study
Randomized but not vaccinated
|
0
|
2
|
0
|
0
|
Baseline Characteristics
A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults
Baseline characteristics by cohort
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=382 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=384 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=47 Participants
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=46 Participants
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Total
n=859 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
336 Participants
n=5 Participants
|
337 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
673 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
186 Participants
n=21 Participants
|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 14.92 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 15.25 • n=7 Participants
|
71.1 years
STANDARD_DEVIATION 4.58 • n=5 Participants
|
71.3 years
STANDARD_DEVIATION 5.29 • n=4 Participants
|
48.6 years
STANDARD_DEVIATION 16.35 • n=21 Participants
|
|
Sex: Female, Male
Female
|
191 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
423 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
191 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
436 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
117 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
234 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
262 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
621 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
311 Participants
n=5 Participants
|
310 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
712 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
306 Participants
n=5 Participants
|
307 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
646 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 days after vaccination with seasonal quadrivalent standard-dose influenza vaccine (Day 29)Population: The PPII set included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for co-administration group and those who received seasonal influenza vaccine alone for control group, for whom immunogenicity data were available for at least one of influenza strains in vaccine. Participants with major protocol deviation were excluded from PPII analysis. 'N' (number of participants analyzed)=participants who were evaluable for this outcome measure.
GMTs of HI antibodies were measured using hemagglutination inhibition (HAI) assay against each of four influenza vaccine strains (A/Victoria \[H1N1\], A/Cambodia \[H3N2\], B/Victoria \[B/Victoria\] and B/Phuket \[B/Yamagata\]). This outcome measure was planned to be analyzed for specified arms only. PPII=Per-protocol influenza immunogenicity.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=320 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=333 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine
A/Victoria (H1N1)
|
306 Titers
Interval 271.0 to 346.0
|
393 Titers
Interval 348.0 to 445.0
|
—
|
—
|
|
Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine
A/Cambodia (H3N2)
|
134 Titers
Interval 119.0 to 150.0
|
165 Titers
Interval 147.0 to 186.0
|
—
|
—
|
|
Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine
B/Victoria (B/Victoria)
|
38 Titers
Interval 34.0 to 43.0
|
38 Titers
Interval 33.0 to 43.0
|
—
|
—
|
|
Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine
B/Phuket (B/Yamagata)
|
32 Titers
Interval 29.0 to 36.0
|
33 Titers
Interval 30.0 to 37.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days after vaccination with Ad26.COV2.S vaccine (Group 1: Day 29, Group 2: Day 57)Population: The per protocol SARS-CoV-2 immunogenicity set (PPSI) included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for co-administration group and Ad26.COV2.S vaccine alone for control group, and for whom immunogenicity data was available. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
GMCs of antibody titers measured by S-ELISA at 28 days after administration of Ad26.COV2.S vaccine was reported. This outcome measure was planned to be analyzed for specified arms only. Seronegative participants (at Day 1) who became serology positive during the study, participants with positive molecular test for severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) and major protocol deviation were excluded from PPSI analysis.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=257 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=209 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Antibodies Measured by Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) 28 Days After Administration of Ad26.COV2.S Vaccine
|
22531 ELISA Unit per milliliter (EU/mL)
Interval 20140.0 to 25205.0
|
25035 ELISA Unit per milliliter (EU/mL)
Interval 22189.0 to 28246.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)Population: The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration. Here, 'n' (number analyzed) signifies participants who were evaluated at each specified category.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=382 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=384 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=47 Participants
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=46 Participants
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination
After first vaccination
|
261 Participants
|
204 Participants
|
23 Participants
|
21 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination
After second vaccination
|
34 Participants
|
210 Participants
|
3 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)Population: The FAS included all randomized participants with at least 1 documented study vaccine administration. Here, 'n' (number analyzed) signifies participants who were evaluated at each specified category.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), headache, fatigue, myalgia, nausea, vomiting were collected within 7 days after each vaccination.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=382 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=384 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=47 Participants
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=46 Participants
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination
After first vaccination
|
256 Participants
|
205 Participants
|
30 Participants
|
26 Participants
|
|
Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination
After second vaccination
|
84 Participants
|
208 Participants
|
8 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 28 days after first vaccination on Day 1 (up to Day 29); 28 days after second vaccination on Day 29 (up to Day 57)Population: The FAS included all randomized participants with at least 1 documented study vaccine administration. Here, 'n' (number analyzed) signifies participants who were evaluated at each specified category.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=382 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=384 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=47 Participants
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=46 Participants
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination
After first vaccination
|
71 Participants
|
71 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination
After second vaccination
|
36 Participants
|
50 Participants
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)Population: The FAS included all randomized participants with at least 1 documented study vaccine administration.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE was any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=382 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=384 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=47 Participants
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=46 Participants
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
9 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)Population: The FAS included all randomized participants with at least 1 documented study vaccine administration.
Number of participants with MAAEs was reported. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. New onset of chronic diseases was collected as part of the MAAEs.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=382 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=384 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=47 Participants
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=46 Participants
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Number of Participants With Medically-attended Adverse Events (MAAEs)
|
51 Participants
|
51 Participants
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)Population: The FAS included all randomized participants with at least 1 documented study vaccine administration.
Number of participants with AESIs was 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), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=382 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=384 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=47 Participants
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=46 Participants
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
|
9 Participants
|
12 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)Population: The FAS included all randomized participants with at least 1 documented study vaccine administration.
Number of participants with AE leading to withdrawal from the study was reported.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=382 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=384 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=47 Participants
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=46 Participants
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Number of Participants With AEs Leading to Withdrawal From the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 days after vaccination with seasonal quadrivalent high-dose influenza vaccine (Day 29)Population: The PPII set included all randomized participants who received Ad26.COV2.S vaccine in combination with a seasonal influenza vaccine for the coadministration group and those who received a seasonal influenza vaccine alone for the control group, for whom immunogenicity data were available for at least one of the influenza strains in the vaccine. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
GMTs of HI antibodies were measured using hemagglutination inhibition (HAI) assay against each of four influenza vaccine strains (A/Victoria \[H1N1\], A/Tasmania\[H3N2\], B/Washington \[B/Victoria\] and B/Phuket \[B/Yamagata\]). This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=43 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=41 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Groups 3 and 4: GMTs of HI Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine
A/Victoria (H1N1)
|
286 Titers
Interval 204.0 to 400.0
|
484 Titers
Interval 369.0 to 636.0
|
—
|
—
|
|
Groups 3 and 4: GMTs of HI Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine
A/Tasmania (H3N2)
|
284 Titers
Interval 200.0 to 402.0
|
509 Titers
Interval 365.0 to 711.0
|
—
|
—
|
|
Groups 3 and 4: GMTs of HI Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine
B/Washington (B/Victoria)
|
61 Titers
Interval 46.0 to 81.0
|
75 Titers
Interval 53.0 to 106.0
|
—
|
—
|
|
Groups 3 and 4: GMTs of HI Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine
B/Phuket (B/Yamagata)
|
38 Titers
Interval 29.0 to 50.0
|
39 Titers
Interval 30.0 to 52.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after vaccination with Ad26.COV2.S vaccine (Group 3: Day 29, Group 4: Day 57)Population: The PPSI included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for the co-administration group and Ad26.COV2.S vaccine alone for the control group, and for whom immunogenicity data was available. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
GMCs of antibody titers measured by S-ELISA at 28 days after administration of Ad26.COV2.S vaccine was reported. This outcome measure was planned to be analyzed for specified arms only. Seronegative participants (at Day 1) who became serology positive during the study, participants with positive molecular test for SARSCoV-2 and major protocol deviation were excluded from PPSI analysis.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=39 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=33 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Group 3 and 4: GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine
|
17569 EU/mL
Interval 13391.0 to 23051.0
|
20743 EU/mL
Interval 12732.0 to 33794.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after the administration of Ad26.COV2.S vaccine (that is, for Groups 1 and 3: Day 29; for Groups 2 and 4: Day 57)Population: PPSI included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for co-administration group and Ad26.COV2.S vaccine alone for control group and for whom immunogenicity data was available. Participants with positive molecular test for SARSCoV-2 were also excluded. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.
GMCs of antibodies measured by S-ELISA 28 days after administration of Ad26.COV.S vaccine in Covid-19 vaccine naive participants was reported. In the below data table, '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=46 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=40 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=1 Participants
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine in COVID-19 Vaccine Naive Participants
|
10340 EU/mL
Interval 6557.0 to 16306.0
|
14704 EU/mL
Interval 9010.0 to 23998.0
|
—
|
38905 EU/mL
Here, 'NA' indicated that lower limit and upper limit of 95% confidence interval could not be estimated as only 1 participant was analyzed on Day 57 in Group 4.
|
SECONDARY outcome
Timeframe: 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29)Population: The PPII set included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for co-administration group and those who received seasonal influenza vaccine alone for control group, for whom immunogenicity data were available for at least one of influenza strains in vaccine. Participants with major protocol deviation were excluded from PPII analysis. 'N' (number of participants analyzed)=participants who were evaluable for this outcome measure.
Seroconversion was defined for each of the 4 influenza vaccine strains (For group 1 and 2: A/Victoria \[H1N1\], A/Cambodia \[H3N2\], B/Victoria \[B/Victoria\], B/Phuket \[B/Yamagata\]; For group 3 and 4: A/Victoria \[H1N1\], B/Phuket (B/Yamagata), A/Tasmania \[H3N2\], B/Washington \[B/Victoria\]) at 28 days after the administration of a seasonal quadrivalent (high-dose and standard-dose) influenza vaccine: HI titer greater than or equal to (\>=) 1:40 in participants with a pre-vaccination HI titer of less than (\<) 1:10, or a \>=4-fold HI titer increase in participants with a pre-vaccination HI titer of \>= 1:10. In the below data table, '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=320 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=333 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=43 Participants
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=41 Participants
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion for Each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
A/Victoria (H1N1)
|
64.1 Percentage of participants
Interval 58.5 to 69.3
|
70.0 Percentage of participants
Interval 64.7 to 74.8
|
65.1 Percentage of participants
Interval 49.1 to 79.0
|
70.7 Percentage of participants
Interval 54.5 to 83.9
|
|
Percentage of Participants With Seroconversion for Each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
A/Cambodia (H3N2)
|
39.1 Percentage of participants
Interval 33.7 to 44.6
|
46.8 Percentage of participants
Interval 41.4 to 52.4
|
—
|
—
|
|
Percentage of Participants With Seroconversion for Each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
B/Victoria (B/Victoria)
|
42.8 Percentage of participants
Interval 37.3 to 48.4
|
43.5 Percentage of participants
Interval 38.1 to 49.1
|
—
|
—
|
|
Percentage of Participants With Seroconversion for Each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
B/Phuket (B/Yamagata)
|
35.3 Percentage of participants
Interval 30.1 to 40.8
|
36.9 Percentage of participants
Interval 31.7 to 42.4
|
37.2 Percentage of participants
Interval 23.0 to 53.3
|
34.1 Percentage of participants
Interval 20.1 to 50.6
|
|
Percentage of Participants With Seroconversion for Each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
A/Tasmania (H3N2)
|
—
|
—
|
72.1 Percentage of participants
Interval 56.3 to 84.7
|
70.7 Percentage of participants
Interval 54.5 to 83.9
|
|
Percentage of Participants With Seroconversion for Each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
B/Washington (B/Victoria)
|
—
|
—
|
41.9 Percentage of participants
Interval 27.0 to 57.9
|
53.7 Percentage of participants
Interval 37.4 to 69.3
|
SECONDARY outcome
Timeframe: 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29)Population: The PPII set included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for coadministration group and those who received seasonal influenza vaccine alone for control group, for whom immunogenicity data were available for at least one of influenza strains in vaccine. Participants with major protocol deviation were excluded from PPII analysis. 'N' (number of participants analyzed)=participants who were evaluable for this outcome measure.
Seroprotection was defined for each of the 4 influenza vaccine strains (For group 1 and 2: A/Victoria \[H1N1\], A/Cambodia \[H3N2\], B/Victoria \[B/Victoria\], B/Phuket \[B/Yamagata\]; For group 3 and 4: A/Victoria \[H1N1\], B/Phuket (B/Yamagata), A/Tasmania \[H3N2\], B/Washington \[B/Victoria\]) as HI titer \>=1:40 at 28 days after the administration of a seasonal quadrivalent (high-dose and standard-dose) influenza vaccine. In the below data table, '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=320 Participants
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=333 Participants
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=43 Participants
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=41 Participants
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Percentage of Participants With Seroprotection for Each of the 4 Influenza Vaccine Strains as HI Titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
A/Victoria (H1N1)
|
97.8 Percentage of participants
Interval 95.5 to 99.1
|
97.3 Percentage of participants
Interval 94.9 to 98.8
|
100.0 Percentage of participants
Interval 91.8 to 100.0
|
100.0 Percentage of participants
Interval 91.4 to 100.0
|
|
Percentage of Participants With Seroprotection for Each of the 4 Influenza Vaccine Strains as HI Titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
A/Cambodia (H3N2)
|
92.8 Percentage of participants
Interval 89.4 to 95.4
|
93.4 Percentage of participants
Interval 90.2 to 95.8
|
—
|
—
|
|
Percentage of Participants With Seroprotection for Each of the 4 Influenza Vaccine Strains as HI Titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
B/Victoria (B/Victoria)
|
56.9 Percentage of participants
Interval 51.2 to 62.4
|
57.4 Percentage of participants
Interval 51.8 to 62.7
|
—
|
—
|
|
Percentage of Participants With Seroprotection for Each of the 4 Influenza Vaccine Strains as HI Titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
B/Phuket (B/Yamagata)
|
52.2 Percentage of participants
Interval 46.6 to 57.8
|
55.0 Percentage of participants
Interval 49.4 to 60.4
|
62.8 Percentage of participants
Interval 46.7 to 77.0
|
63.4 Percentage of participants
Interval 46.9 to 77.9
|
|
Percentage of Participants With Seroprotection for Each of the 4 Influenza Vaccine Strains as HI Titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
A/Tasmania (H3N2)
|
—
|
—
|
97.7 Percentage of participants
Interval 87.7 to 99.9
|
100.0 Percentage of participants
Interval 91.4 to 100.0
|
|
Percentage of Participants With Seroprotection for Each of the 4 Influenza Vaccine Strains as HI Titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
B/Washington (B/Victoria)
|
—
|
—
|
79.1 Percentage of participants
Interval 64.0 to 90.0
|
82.9 Percentage of participants
Interval 67.9 to 92.8
|
Adverse Events
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
Serious events: 9 serious events
Other events: 45 other events
Deaths: 0 deaths
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
Serious events: 7 serious events
Other events: 45 other events
Deaths: 0 deaths
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 1 deaths
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=382 participants at risk
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=384 participants at risk
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=47 participants at risk
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=46 participants at risk
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.26%
1/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.26%
1/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
2.1%
1/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Cardiac disorders
Chronic Left Ventricular Failure
|
0.00%
0/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.26%
1/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Hepatobiliary disorders
Biliary Obstruction
|
0.26%
1/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Infections and infestations
Covid-19
|
0.00%
0/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.26%
1/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Infections and infestations
Staphylococcal Infection
|
0.26%
1/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.26%
1/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.26%
1/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
2.2%
1/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Neoplasm
|
0.00%
0/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.26%
1/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia Vera
|
0.26%
1/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Nervous system disorders
Optic Neuritis
|
0.00%
0/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.26%
1/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Psychiatric disorders
Bipolar Disorder
|
0.26%
1/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
2.2%
1/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Reproductive system and breast disorders
Abnormal Uterine Bleeding
|
0.26%
1/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.26%
1/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.26%
1/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.26%
1/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.26%
1/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.26%
1/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
0.00%
0/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
Other adverse events
| Measure |
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo
n=382 participants at risk
Participants aged greater than or equal to (\>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5\*10\^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S
n=384 participants at risk
Participants aged \>=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo
n=47 participants at risk
Participants aged \>=65 years and older received a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
|
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S
n=46 participants at risk
Participants aged \>=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5\*10\^10 vp dose level on Day 29.
|
|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
11.0%
42/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
10.9%
42/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
21.3%
10/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
10.9%
5/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
|
Infections and infestations
Nasopharyngitis
|
0.79%
3/382 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
1.3%
5/384 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
4.3%
2/47 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
6.5%
3/46 • From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
|
Additional Information
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 with hold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER