Trial Outcomes & Findings for A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19) (NCT NCT04765384)
NCT ID: NCT04765384
Last Updated: 2025-05-25
Results Overview
Number of adult participants with solicited local AEs for 7 days post first vaccination was 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 AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post first vaccination (day of first vaccination and the subsequent 7 days). Solicited local AEs are injection site pain/tenderness, erythema, swelling at the vaccination site.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
From first vaccination on Day 1 up to 7 days post first vaccination (up to Day 8)
Results posted on
2025-05-25
Participant Flow
Per plan, only adults were considered enrolled in the study.
Per change in planned analyses, combined analysis was performed for Groups 2 and 3 in both adults and neonates in order to protect and maintain the privacy/confidentiality of the single participant enrolled in Group 2. Each adult participant in Group 4 received booster dose at a different timepoint, that is, any day from Day 84 up to Day 364.
Participant milestones
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
Group 1 (Neonates and Infants)
Neonates and infants of mothers from Group 1 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
Groups 2 and 3 (Neonates and Infants)
Neonates and infants of mothers from Groups 2 and 3 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
Group 4 (Neonates and Infants)
Neonates and infants of mothers from Group 4 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
|---|---|---|---|---|---|---|
|
Post-baseline: Adults
STARTED
|
12
|
10
|
29
|
0
|
0
|
0
|
|
Post-baseline: Adults
Adult Participants Who Received Booster Vaccination
|
0
|
0
|
13
|
0
|
0
|
0
|
|
Post-baseline: Adults
Group 2
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Post-baseline: Adults
Group 3
|
0
|
9
|
0
|
0
|
0
|
0
|
|
Post-baseline: Adults
COMPLETED
|
10
|
8
|
23
|
0
|
0
|
0
|
|
Post-baseline: Adults
NOT COMPLETED
|
2
|
2
|
6
|
0
|
0
|
0
|
|
Post-natal: Neonates and Infants
STARTED
|
0
|
0
|
0
|
10
|
8
|
29
|
|
Post-natal: Neonates and Infants
Group 2
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Post-natal: Neonates and Infants
Group 3
|
0
|
0
|
0
|
0
|
7
|
0
|
|
Post-natal: Neonates and Infants
COMPLETED
|
0
|
0
|
0
|
9
|
8
|
21
|
|
Post-natal: Neonates and Infants
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
8
|
Reasons for withdrawal
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
Group 1 (Neonates and Infants)
Neonates and infants of mothers from Group 1 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
Groups 2 and 3 (Neonates and Infants)
Neonates and infants of mothers from Groups 2 and 3 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
Group 4 (Neonates and Infants)
Neonates and infants of mothers from Group 4 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
|---|---|---|---|---|---|---|
|
Post-baseline: Adults
Lost to Follow-up
|
0
|
1
|
3
|
0
|
0
|
0
|
|
Post-baseline: Adults
Withdrawal by Subject
|
2
|
1
|
3
|
0
|
0
|
0
|
|
Post-natal: Neonates and Infants
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Post-natal: Neonates and Infants
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Post-natal: Neonates and Infants
Withdrawal by Parent Or Guardian
|
0
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)
Baseline characteristics by cohort
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=12 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 3.42 • n=5 Participants
|
24.2 years
STANDARD_DEVIATION 3.61 • n=7 Participants
|
25.4 years
STANDARD_DEVIATION 5.29 • n=5 Participants
|
24.9 years
STANDARD_DEVIATION 4.57 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 up to 7 days post first vaccination (up to Day 8)Population: Full Analysis Set - Adults (FAS-A) included all enrolled adult participants with at least one vaccine administration documented.
Number of adult participants with solicited local AEs for 7 days post first vaccination was 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 AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post first vaccination (day of first vaccination and the subsequent 7 days). Solicited local AEs are injection site pain/tenderness, erythema, swelling at the vaccination site.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=12 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Adult Participants With Solicited Local Adverse Events (AEs) for 7 Days Post First Vaccination
|
10 Participants
|
5 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 up to 7 days post first vaccination (up to Day 8)Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented.
Number of adult participants with solicited systemic AEs for 7 days post first vaccination was 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 AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post first vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post first vaccination (day of first vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=12 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Adult Participants With Solicited Systemic AEs for 7 Days Post First Vaccination
|
10 Participants
|
4 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 up to 28 days post first vaccination (up to Day 29)Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented.
Number of adult participants with unsolicited AEs for 28 days post first vaccination was reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=12 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Adult Participants With Unsolicited AEs for 28 Days Post First Vaccination
|
7 Participants
|
4 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 until end of study (up to post-partum [PP] Day 366 [Day 15 up to Day 554])Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented.
Number of adult participants with SAEs from first vaccination until EOS 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. SAEs were defined as 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 (Adults): Ad26.COV2.S 5*10^10 vp
n=12 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Adult Participants With Serious Adverse Events (SAEs) From First Vaccination Until End of the Study (EOS)
|
4 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 until end of study (up to PP Day 366 [Day 15 up to Day 554])Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented.
Number of adult participants with AESIs from first vaccination until EOS were reported. Thrombosis with thrombocytopenia syndrome (TTS) in adults was considered an AESI in this study. TTS is a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=12 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Adult Participants With Adverse Events of Special Interest (AESIs) From First Vaccination Until EOS
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 until 6 months post first vaccination (up to Day 183)Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented.
Number of adult participants with MAAEs until 6 months post first vaccination 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. Routine study visits were not considered medically attended visits. New onset of chronic diseases was collected as part of the MAAEs.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=12 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Adult Participants With Medically Attended Adverse Events (MAAEs) Until 6 Months Post First Vaccination
|
6 Participants
|
2 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 until end of study (up to PP Day 366 [Day 15 up to Day 554])Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented.
Number of adult participants with AEs leading to study discontinuation 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. All AEs leading to discontinuation from the study (regardless of the causal relationship) were reported for all adult participants from the moment of first vaccination until completion of the participant's last study-related procedure.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=12 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Adult Participants With AEs Leading to Study Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 days post first vaccination on Day 1 (at Day 29)Population: Per-protocol Immunogenicity-Adults (PPI-A) set included all vaccinated adult participants for whom immunogenicity data were available excluding adult participants with major protocol deviations that were expected to impact the immunogenicity outcomes. Here, "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Serological response to vaccination as measured by S-ELISA in adult participants 28 days post first vaccination was reported.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=9 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=8 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=24 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Serological Response to Vaccination as Measured by S-Enzyme-linked Immunosorbent Assay (S-ELISA) in Adult Participants 28 Days Post First Vaccination
|
19179 ELISA units per milliliter (EU/mL)
Interval 10137.0 to 36284.0
|
12335 ELISA units per milliliter (EU/mL)
Interval 8796.0 to 17299.0
|
5906 ELISA units per milliliter (EU/mL)
Interval 2784.0 to 12529.0
|
SECONDARY outcome
Timeframe: 7 days post booster vaccination (Day 84 up to Day 371)Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Data for this outcome measure was planned to be collected and analyzed only for the participants in arm "Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5\*10\^10 vp", as only this arm received the booster vaccination.
Number of adult participants with solicited local AEs for 7 days post booster vaccination was 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 AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post booster vaccination (day of booster vaccination and the subsequent 7 days). Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=13 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Group 4: Number of Adult Participants With Solicited Local AEs for 7 Days Post Booster Vaccination
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days post booster vaccination (Day 84 up to Day 371)Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Data for this outcome measure was planned to be collected and analyzed only for the participants in arm "Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5\*10\^10 vp", as only this arm received the booster vaccination.
Number of adult participants with solicited systemic AEs for 7 days post booster vaccination was 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 AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post booster vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of booster vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=13 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Group 4: Number of Adult Participants With Solicited Systemic AEs for 7 Days Post Booster Vaccination
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days post booster vaccination (Day 84 up to Day 392)Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Data for this outcome measure was planned to be collected and analyzed only for the participants in arm "Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5\*10\^10 vp", as only this arm received the booster vaccination.
Number of adult participants with unsolicited AEs for 28 days post booster vaccination was reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=13 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Group 4: Number of Adult Participants With Unsolicited AEs for 28 Days Post Booster Vaccination
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From booster vaccination (Day 84 up to Day 364) until EOS (up to PP Day 366 [Day 366 up to Day 554])Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Data for this outcome measure was planned to be collected and analyzed only for the participants in arm "Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5\*10\^10 vp", as only this arm received the booster vaccination.
Number of adult participants with SAEs post booster vaccination until EOS were reported. 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. SAE were defined as 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 (Adults): Ad26.COV2.S 5*10^10 vp
n=13 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Group 4: Number of Adult Participants With SAEs Post Booster Vaccination Until EOS
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From booster vaccination (Day 84 up to Day 364) until EOS (up to PP Day 366 [Day 366 up to Day 554])Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Data for this outcome measure was planned to be collected and analyzed only for the participants in arm "Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5\*10\^10 vp", as only this arm received the booster vaccination.
Number of adult participants with AESI post booster vaccination until EOS were reported. Thrombosis with thrombocytopenia syndrome (TTS) in adults was considered an AESI in this study. TTS is a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=13 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Group 4: Number of Adult Participants With AESIs Post Booster Vaccination Until EOS
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months post booster vaccination (Day 84 up to Day 546)Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Data for this outcome measure was planned to be collected and analyzed only for the participants in arm "Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5\*10\^10 vp", as only this arm received the booster vaccination.
Number of adult participants with MAAEs until 6 months post booster vaccination were 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. Routine study visits were not considered medically attended visits. New onset of chronic diseases was collected as part of the MAAEs.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=13 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Group 4: Number of Adult Participants With MAAEs Until 6 Months Post Booster Vaccination
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From post booster vaccination (Day 84 up to Day 364) until EOS (up to PP Day 366 [Day 366 up to Day 554])Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Data for this outcome measure was planned to be collected and analyzed only for the participants in arm "Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5\*10\^10 vp", as only this arm received the booster vaccination.
Number of adult participants with AEs leading to study discontinuation post booster vaccination until EOS 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. All AEs leading to discontinuation from the study (regardless of the causal relationship) were reported for all adult participants from the moment of booster vaccination until completion of the participant's last study-related procedure.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=13 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Group 4: Number of Adult Participants With AEs Leading to Study Discontinuation Post Booster Vaccination Until EOS
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first vaccination on Day 1 until PP Day 1 (Day 7 up to Day 163)Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Number of adult participants with pregnancy outcomes were reported. Pregnancy outcomes in adult participants included live term birth, live preterm birth, stillbirth, and abortion.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=8 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Adult Participants With Pregnancy Outcomes
Live Term Birth
|
10 Participants
|
7 Participants
|
26 Participants
|
|
Number of Adult Participants With Pregnancy Outcomes
Live Preterm Birth
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Adult Participants With Pregnancy Outcomes
Stillbirth
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adult Participants With Pregnancy Outcomes
Abortion
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first vaccination on Day 1 until PP Day 1 (Day 7 up to Day 163)Population: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Here "n"(number analyzed) signifies number of participants analyzed for specified categories.
Number of adult participants with pregnancy related AEs throughout pregnancy were reported. Pregnancy related AEs in adult participants were collected based on 2 baseline gestational age groups (adult participants who received vaccination at 16 to 27 weeks \[\>=16 weeks to \<28 weeks\] and at 28 to 38 weeks \[\>=28 weeks to \<=38 weeks\]) and included gestational hypertension, foetal growth restriction, haemorrhage in pregnancy, polyhydramnios, pre-eclampsia, premature rupture of membranes, preterm premature rupture of membranes, bradycardia foetal, premature baby, amniorrhexis, foetalgrowth restriction, amniotic fluid volume decreased.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=12 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Adult Participants With Pregnancy Related AEs Throughout Pregnancy
Gestational Age: 16-27 weeks
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Adult Participants With Pregnancy Related AEs Throughout Pregnancy
Gestational Age: 28-38 weeks
|
1 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 29, PP Day 1 (Day 7 up to Day 163), PP Day 183 (Day 189 up to Day 345)Population: PPI-A set included all vaccinated adult participants for whom immunogenicity data were available excluding adult participants with major protocol deviations that were expected to impact the immunogenicity outcomes. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n" (number analyzed) signifies number of participants analyzed at specified timepoints.
Serological response to first vaccination as measured by S-ELISA at all blood collection timepoints post first vaccination were reported.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=9 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=9 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Serological Response to First Vaccination as Measured by S-ELISA in Adult Participants at All Blood Collection Timepoints Post First Vaccination
Day 1
|
10977 ELISA Units per milliliter (EU/mL)
Interval 7375.0 to 16336.0
|
2927 ELISA Units per milliliter (EU/mL)
Interval 1266.0 to 6770.0
|
197 ELISA Units per milliliter (EU/mL)
Interval 101.0 to 383.0
|
|
Serological Response to First Vaccination as Measured by S-ELISA in Adult Participants at All Blood Collection Timepoints Post First Vaccination
Day 29
|
19179 ELISA Units per milliliter (EU/mL)
Interval 10137.0 to 36284.0
|
12335 ELISA Units per milliliter (EU/mL)
Interval 8796.0 to 17299.0
|
5906 ELISA Units per milliliter (EU/mL)
Interval 2784.0 to 12529.0
|
|
Serological Response to First Vaccination as Measured by S-ELISA in Adult Participants at All Blood Collection Timepoints Post First Vaccination
PP Day 1 (Day 7 up to Day 163)
|
16733 ELISA Units per milliliter (EU/mL)
Interval 8776.0 to 31903.0
|
10179 ELISA Units per milliliter (EU/mL)
Interval 5418.0 to 19123.0
|
4025 ELISA Units per milliliter (EU/mL)
Interval 2115.0 to 7659.0
|
|
Serological Response to First Vaccination as Measured by S-ELISA in Adult Participants at All Blood Collection Timepoints Post First Vaccination
PP Day 183 (Day 189 up to Day 345)
|
12704 ELISA Units per milliliter (EU/mL)
Interval 8852.0 to 18233.0
|
8846 ELISA Units per milliliter (EU/mL)
Interval 5851.0 to 13373.0
|
4698 ELISA Units per milliliter (EU/mL)
Interval 2652.0 to 8324.0
|
SECONDARY outcome
Timeframe: 28 days post first vaccination on Day 1 (at Day 29)Population: PPI-A set included all vaccinated adult participants for whom immunogenicity data were available excluding adult participants with major protocol deviations that were expected to impact the immunogenicity outcomes. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Serological response to first vaccination measured by VNA titers at 28 days in adult participants post first vaccination was reported. Data were expressed as 50 percent (%) inhibitory concentration (IC50) units.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=9 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=8 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=24 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Serological Response to First Vaccination as Measured by Virus Neutralization Assay (VNA) Titers, 28 Days in Adult Participants Post First Vaccination
|
7233 titers
Interval 3410.0 to 15342.0
|
5527 titers
Interval 3106.0 to 9834.0
|
1601 titers
Interval 639.0 to 4012.0
|
SECONDARY outcome
Timeframe: Booster Day 1 (Day 84 up to Day 364), Booster Day 29 (Day 112 up to Day 392)Population: PPI-A set included all vaccinated adult participants with available immunogenicity data excluding participants with major protocol deviations that impact immunogenicity outcomes. Data for this outcome measure was planned to be collected and analyzed only for the participants in arm "Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5\*10\^10 vp", as only this arm received the booster vaccination.
Serological response to vaccination as measured by binding (S-ELISA) antibody titers in adult participants at blood collection time points post booster vaccination were reported.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=13 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Group 4: Serological Response to Booster Vaccination Measured by Binding (S-ELISA) Antibody Titers in Adult Participants at Blood Collection Time Points Post Booster Vaccination
Booster Day 29 (Day 112 up to Day 392)
|
7213 ELISA Units per milliliter (EU/mL)
Interval 4417.0 to 11780.0
|
—
|
—
|
|
Group 4: Serological Response to Booster Vaccination Measured by Binding (S-ELISA) Antibody Titers in Adult Participants at Blood Collection Time Points Post Booster Vaccination
Booster Day 1 (Day 84 up to Day 364)
|
4204 ELISA Units per milliliter (EU/mL)
Interval 1996.0 to 8857.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Day 1 (Day 84 up to Day 364), Booster Day 29 (Day 112 up to Day 392)Population: PPI-A set included all vaccinated adult participants with available immunogenicity data excluding participants with major protocol deviations that impact immunogenicity outcomes. Data for this outcome measure was planned to be collected and analyzed only for the participants in arm "Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5\*10\^10 vp", as only this arm received the booster vaccination.
Serological response to booster vaccination measured by neutralizing VNA antibody titers in adult participants at blood collection time points post booster vaccination were reported. Data were expressed as IC50 units.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=13 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Group 4: Serological Response to Booster Vaccination Measured by Neutralizing (VNA) Antibody Titers in Adult Participants at Blood Collection Time Points Post Booster Vaccination
Booster Day 1 (Day 84 up to Day 364)
|
1299 titers
Interval 419.0 to 4029.0
|
—
|
—
|
|
Group 4: Serological Response to Booster Vaccination Measured by Neutralizing (VNA) Antibody Titers in Adult Participants at Blood Collection Time Points Post Booster Vaccination
Booster Day 29 (Day 112 up to Day 392)
|
3203 titers
Interval 1166.0 to 8802.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At birth (postnatal [PN] Day 1 [Day 7 up to Day 163]), 2 months (up to PN Day 61 [Day 67 up to Day 223]) and 6 months (up to PN Day 183 [Day 189 up to Day 345])Population: Per-protocol immunogenicity- non-vaccinated neonates/infants (PPI-NVN) included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants for whom immunogenicity data were available. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n"(number analyzed) signifies number of participants analyzed at specified timepoints.
Serological response to vaccination as measured by S-ELISA at birth (that is, in cord blood) and at 2 months and 6 months of age in neonates and infants born to adult participants were reported.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=7 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=6 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=23 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Serological Response to Vaccination as Measured by S-ELISA at Birth (That is, in Cord Blood) and at 2 Months and 6 Months of Age in Neonates and Infants Born to Adult Participants
PN Day 1 [Day 7 up to Day 163])
|
17327 ELISA Units per milliliter (EU/mL)
Interval 9676.0 to 31027.0
|
11540 ELISA Units per milliliter (EU/mL)
Interval 6862.0 to 19406.0
|
4013 ELISA Units per milliliter (EU/mL)
Interval 1758.0 to 9162.0
|
|
Serological Response to Vaccination as Measured by S-ELISA at Birth (That is, in Cord Blood) and at 2 Months and 6 Months of Age in Neonates and Infants Born to Adult Participants
PN Day 61 [Day 67 up to Day 223])
|
4021 ELISA Units per milliliter (EU/mL)
Interval 1856.0 to 8711.0
|
3520 ELISA Units per milliliter (EU/mL)
Interval 1740.0 to 7123.0
|
2996 ELISA Units per milliliter (EU/mL)
Interval 1697.0 to 5289.0
|
|
Serological Response to Vaccination as Measured by S-ELISA at Birth (That is, in Cord Blood) and at 2 Months and 6 Months of Age in Neonates and Infants Born to Adult Participants
PN Day 183 [Day 189 up to Day 345)
|
529 ELISA Units per milliliter (EU/mL)
Interval 230.0 to 1216.0
|
477 ELISA Units per milliliter (EU/mL)
Interval 217.0 to 1048.0
|
795 ELISA Units per milliliter (EU/mL)
Interval 390.0 to 1618.0
|
SECONDARY outcome
Timeframe: At Birth (PN Day 1 [Day 7 up to Day 163])Population: Per-protocol immunogenicity- non-vaccinated neonates/infants (PPI-NVN) included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants for whom immunogenicity data were available. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Serological response to vaccination as measured by VNA titers at birth (that is, in cord blood) in neonates and infants born to adult participants were reported. Data were expressed as IC50 units.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=6 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=6 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=26 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Serological Response to Vaccination as Measured by VNA Titers at Birth (That is, in Cord Blood) in Neonates and Infants Born to Adult Participants
|
3788 titers
Interval 1776.0 to 8082.0
|
3756 titers
Interval 1740.0 to 8106.0
|
658 titers
Interval 236.0 to 1834.0
|
SECONDARY outcome
Timeframe: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528])Population: Full Analysis Set - Non-vaccinated Neonates/Infants (FAS-NVN) included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants.
An AE is any untoward medical occurrence in participants in the study that does not necessarily have a causal relationship with pharmaceutical/biological agent under study. SAE: any untoward medical occurrence that resulted in 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. MIS-C: a serious and potentially fatal condition in infants and children with SARS-CoV-2, which resulted in inflammation involving multiple organs. Symptoms of MIS-C: persistent fever, fatigue and signs and symptoms including multiorgan systems (cardiac, gastrointestinal, renal, hematologic, dermatologic, neurologic) involvement, elevated inflammatory markers and, in severe cases, hypotension and shock.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=8 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Neonates and Infants With SAEs (Including MIS-C) From Birth Up to 12 Months of Age in Neonates and Infants Born to Adult Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From birth (PN Day 1 [Day 7 up to Day 163]) until 12 months of age (up to PN Day 366 [Day 372 up to Day 528])Population: FAS-NVN included all non-vaccinated neonates/infants (NVN) born to Ad26.COV2.S vaccinated adult participants.
Number of neonates and infants with AESIs from birth until 12 months of age in neonates and infants born to adult participants were reported. TTS is a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=8 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Neonates and Infants With AESIs From Birth Until 12 Months of Age in Neonates and Infants Born to Adult Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From birth (PN Day 1 [Day 7 up to Day 163]) until 6 months of age (up to PN 183 [Day 189 up to Day 345])Population: FAS-NVN included all non-vaccinated neonates/infants (NVN) born to Ad26.COV2.S vaccinated adult participants.
Number of neonates and infants with MAAEs from birth until 6 months of age in neonates and infants born to adult participants were 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. Routine study visits were not considered medically attended visits. New onset of chronic diseases were collected as part of the MAAEs.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=8 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Neonates and Infants With MAAEs From Birth Until 6 Months of Age in Neonates and Infants Born to Adult Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From birth (PN Day 1 [Day 7 up to Day 163]) until study discontinuation (until 12 months of age [up to PN Day 366 {Day 372 up to Day 528}])Population: FAS-NVN included all non-vaccinated neonates/infants (NVN) born to Ad26.COV2.S vaccinated adult participants.
Number of neonates and infants with AEs leading to study discontinuation from birth until study discontinuation were reported. An AE is any untoward medical occurrence in participants who does not necessarily have a causal relationship with pharmaceutical/biological agent under study. All AEs leading to discontinuation from the study (regardless of the causal relationship) were reported for all neonates and infants.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=8 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Neonates and Infants With AEs Leading to Study Discontinuation From Birth Until Study Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528])Population: FAS-NVN included all non-vaccinated neonates/infants (NVN) born to Ad26.COV2.S vaccinated adult participants. Here 'N' (Number of participants analyzed) signifies the number of participants who completed the neonatal medical history form and were analyzed for this outcome measure.
Number of neonates and infants with different birth outcomes from birth until 12 months of age were reported. Neonate/infant outcomes included normal neonate, term neonate with (or without) complications, preterm neonate with (or without) complications, neonatal infection, respiratory distress, congenital anomalies, neonatal death, low birth weight, and small for gestational age.
Outcome measures
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=8 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 Participants
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
|---|---|---|---|
|
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
Normal neonate
|
9 Participants
|
7 Participants
|
25 Participants
|
|
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
Preterm neonate with complications
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
Term neonate with complications
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
Neonatal infection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
Respiratory distress
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
Congenital anomalies
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
Neonatal death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
Low birth weight
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
Small for gestational age
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
Preterm neonate without complications
|
0 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Group 1 (Neonates and Infants)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Groups 2 and 3 (Neonates and Infants)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 4 (Neonates and Infants)
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=12 participants at risk
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 participants at risk
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 participants at risk
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
Group 1 (Neonates and Infants)
n=10 participants at risk
Neonates and infants of mothers from Group 1 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
Groups 2 and 3 (Neonates and Infants)
n=8 participants at risk
Neonates and infants of mothers from Groups 2 and 3 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
Group 4 (Neonates and Infants)
n=29 participants at risk
Neonates and infants of mothers from Group 4 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia Foetal
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Congenital, familial and genetic disorders
Ventricular Septal Defect
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
General disorders
Hypothermia
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Hepatobiliary disorders
Cholestasis of Pregnancy
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Hepatobiliary disorders
Neonatal Cholestasis
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Arboviral Infection
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Bronchitis Viral
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational Hypertension
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in Pregnancy
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice Neonatal
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Placental Insufficiency
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-Eclampsia
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Premature Baby
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm Premature Rupture of Membranes
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Psychiatric disorders
Perinatal Depression
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Transient Tachypnoea of the Newborn
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
Other adverse events
| Measure |
Group 1 (Adults): Ad26.COV2.S 5*10^10 vp
n=12 participants at risk
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) exclusively with messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine (primary vaccination \[2-doses\] or homologous booster vaccination) with COVID-19 mRNA vaccine (Pfizer-BioNTech or Moderna) received a single dose of the adenovirus type 26 (Ad26) vector, encoded with spike (S) protein from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Ad26.COV2.S) 5\*10\^10 viral particles (vp) as intramuscular (IM) injection on Day 1.
|
Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp
n=10 participants at risk
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), previously vaccinated (at least 4 months prior to receiving the study vaccine) with any regimen not included in Group 1 (non-mRNA or heterologous regimen) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1.
|
Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp
n=29 participants at risk
Adult participants from 2nd or 3rd trimester of pregnancy (Week 16 to Week 38 of gestation, inclusive), with no prior COVID-19 vaccination (vaccine- naive) received a single dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Day 1 followed by an optional single booster dose of Ad26.COV2.S 5\*10\^10 vp as IM injection on Booster Day 1 (any day between Day 84 and Day 364).
|
Group 1 (Neonates and Infants)
n=10 participants at risk
Neonates and infants of mothers from Group 1 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
Groups 2 and 3 (Neonates and Infants)
n=8 participants at risk
Neonates and infants of mothers from Groups 2 and 3 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
Group 4 (Neonates and Infants)
n=29 participants at risk
Neonates and infants of mothers from Group 4 (Adults) were followed up for up to 12 months postpartum. Neonates and infants in this group did not receive any active vaccination with Ad26.COV2.S 5\*10\^10 vp.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
4/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Gastrointestinal disorders
Nausea (Solicited)
|
41.7%
5/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
37.9%
11/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
General disorders
Chills
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
General disorders
Fatigue (Solicited)
|
75.0%
9/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
20.0%
2/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
65.5%
19/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
General disorders
Malaise
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
General disorders
Peripheral Swelling
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
General disorders
Pyrexia (Solicited)
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
General disorders
Vaccination Site Erythema (Solicited)
|
25.0%
3/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
General disorders
Vaccination Site Pain (Solicited)
|
83.3%
10/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
50.0%
5/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
69.0%
20/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
General disorders
Vaccination Site Swelling (Solicited)
|
16.7%
2/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
20.0%
2/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Hepatobiliary disorders
Neonatal Cholestasis
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Body Tinea
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
COVID-19
|
16.7%
2/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
30.0%
3/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Cystitis
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Hand-Foot-And-Mouth Disease
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Influenza
|
25.0%
3/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
40.0%
4/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
20.7%
6/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
20.0%
2/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Toxoplasmosis
|
16.7%
2/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Injury, poisoning and procedural complications
Vulvovaginal Injury
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Investigations
Amniotic Fluid Volume Decreased
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Investigations
Blood Sodium Decreased
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Investigations
Coombs Indirect Test Positive
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Investigations
Mns System Antibodies Positive
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Solicited)
|
58.3%
7/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
48.3%
14/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Nervous system disorders
Headache (Solicited)
|
66.7%
8/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
40.0%
4/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
58.6%
17/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
—
0/0 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal Growth Restriction
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational Hypertension
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice Neonatal
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
17.2%
5/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Placental Insufficiency
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Polyhydramnios
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-Eclampsia
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Premature Rupture of Membranes
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Retained Placenta or Membranes
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine Contractions During Pregnancy
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine Hypotonus
|
16.7%
2/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Psychiatric disorders
Perinatal Depression
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Renal and urinary disorders
Leukocyturia
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Reproductive system and breast disorders
Abnormal Uterine Bleeding
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
17.2%
5/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
3.4%
1/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
10.0%
1/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
12.5%
1/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
6.9%
2/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
|
Vascular disorders
Orthostatic Hypotension
|
8.3%
1/12 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/10 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/8 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
0.00%
0/29 • Adult participants: From first vaccination on Day 1 until EOS (up to PP Day 366 [Day 15 up to Day 554]), Neonates & Infants: From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]), Solicited AEs: From first vaccination on Day 1 until 7 days post first vaccination (up to Day 8), Group 4: Solicited AEs (booster vaccination): 7 days post booster vaccination (Day 84 up to Day 371)
Adult participants: FAS-A included all enrolled adult participants with at least one vaccine administration documented. Neonates and Infants: FAS-NVN included all non-vaccinated neonates/infants born to Ad26.COV2.S vaccinated adult participants. For solicited AEs, participants at risk=0 (neonates and infants) signifies that no solicited AEs were collected for infants and neonates since they didn't receive any study vaccination during the study.
|
Additional Information
Vice President Medical Affairs IDV
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