COVID-19 Prevention
Conditions
Brief summary
The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule at the standard dose level in adult participants during the second and/or third trimester of pregnancy and (potentially) post-partum; to assess the humoral immune response in peripheral blood of adult participants to Ad26.COV2.S administered IM as a 1-dose schedule during the second and/or third trimester of pregnancy, 28 days after vaccination.
Detailed description
There is an increased risk of severe coronavirus disease-2019 (COVID-19) during pregnancy, as well as an increased risk of adverse birth outcomes. Therefore, the aim of this study is to assess the safety, reactogenicity and immunogenicity of Ad26.COV2.S in adult participants in the second and/or third trimester of pregnancy. Ad26.COV2.S (also known as Ad26COVS1) is a monovalent vaccine composed of a recombinant, replication incompetent adenovirus type 26 (Ad26) vector, constructed to encode the S protein derived from a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) clinical isolate, stabilized in its prefusion conformation. For each adult participant, the total study duration from screening until the last follow-up visit will be approximately 16 months. The study will consist of a screening phase (28 days), vaccination period (study period from vaccination to pregnancy completion/termination) and a follow-up period (up to 12 months post pregnancy completion/termination). For neonates/infants born to the participants in the study will be followed for approximately 12 months postpartum. Safety assessments will include immunogenicity assessments, physical examination, vital signs, clinical safety laboratory assessments, medical, obstetric and delivery history, pregnancy outcome, neonate safety assessment, adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI).
Interventions
BIOLOGICALAd26.COV2.S
Participants will receive intramuscular (IM) injection of Ad26.COV2.S.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* If on medication for a condition, the medication dose must have been stable for at least 4 weeks preceding vaccination * Participant must be healthy as confirmed by medical history, physical examination, vital signs, and obstetric history performed at Screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled * Participant will be at second or third trimester of pregnancy, that is, Week 16 to Week 38 of gestation (inclusive), at the time of vaccination, based on ultrasound at the time of screening (or not longer than 10 days prior to vaccination if performed elsewhere) * Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine * Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study * Participant either received their last COVID-19 vaccination with an authorized/licensed COVID-19 vaccine (at least 4 months prior to first study vaccination) or is COVID 19 vaccine-naïve
Exclusion criteria
* Participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy) * Participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) * Participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence) * Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) * Participant has a history of any serious, chronic, or progressive neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood * Participant has a positive diagnostic test result (polymerase chain reaction \[PCR\] based viral ribonucleic acid \[RNA\] detection) severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at screening or Day 1 (if more than 4 days in between) * Participant has a history of thrombosis with thrombocytopenia syndrome (TTS), including cerebral venous sinus thrombosis (CVST), or heparin-induced thrombocytopenia (HIT) * Participant has a history of capillary leak syndrome (CLS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adult Participants With Solicited Local Adverse Events (AEs) for 7 Days Post First Vaccination | From first vaccination on Day 1 up to 7 days post first vaccination (up to Day 8) | 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. |
| Number of Adult Participants With Solicited Systemic AEs for 7 Days Post First Vaccination | From first vaccination on Day 1 up to 7 days post first vaccination (up to Day 8) | 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. |
| Number of Adult Participants With Unsolicited AEs for 28 Days Post First Vaccination | From first vaccination on Day 1 up to 28 days post first vaccination (up to Day 29) | 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. |
| Number of Adult Participants With Serious Adverse Events (SAEs) From First Vaccination Until End of the Study (EOS) | From first vaccination on Day 1 until end of study (up to post-partum [PP] Day 366 [Day 15 up to Day 554]) | 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. |
| Number of Adult Participants With Adverse Events of Special Interest (AESIs) From First Vaccination Until EOS | From first vaccination on Day 1 until end of study (up to PP Day 366 [Day 15 up to Day 554]) | 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. |
| Number of Adult Participants With Medically Attended Adverse Events (MAAEs) Until 6 Months Post First Vaccination | From first vaccination on Day 1 until 6 months post first vaccination (up to Day 183) | 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. |
| Number of Adult Participants With AEs Leading to Study Discontinuation | From first vaccination on Day 1 until end of study (up to PP Day 366 [Day 15 up to Day 554]) | 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. |
| Serological Response to Vaccination as Measured by S-Enzyme-linked Immunosorbent Assay (S-ELISA) in Adult Participants 28 Days Post First Vaccination | 28 days post first vaccination on Day 1 (at Day 29) | Serological response to vaccination as measured by S-ELISA in adult participants 28 days post first vaccination was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adult Participants With Pregnancy Related AEs Throughout Pregnancy | From first vaccination on Day 1 until PP Day 1 (Day 7 up to Day 163) | 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. |
| Serological Response to First Vaccination as Measured by S-ELISA in Adult Participants at All Blood Collection Timepoints Post First Vaccination | Day 1, Day 29, PP Day 1 (Day 7 up to Day 163), PP Day 183 (Day 189 up to Day 345) | Serological response to first vaccination as measured by S-ELISA at all blood collection timepoints post first vaccination were reported. |
| Serological Response to First Vaccination as Measured by Virus Neutralization Assay (VNA) Titers, 28 Days in Adult Participants Post First Vaccination | 28 days post first vaccination on Day 1 (at Day 29) | 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. |
| 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), Booster Day 29 (Day 112 up to Day 392) | 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. |
| 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), Booster Day 29 (Day 112 up to Day 392) | 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. |
| 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 | 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]) | 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. |
| Group 4: Number of Adult Participants With Solicited Local AEs for 7 Days Post Booster Vaccination | 7 days post booster vaccination (Day 84 up to Day 371) | 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. |
| 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 | From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]) | 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. |
| Number of Neonates and Infants With AESIs From Birth Until 12 Months of Age in Neonates and Infants Born to Adult Participants | 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]) | 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. |
| Number of Neonates and Infants With MAAEs From Birth Until 6 Months of Age in Neonates and Infants Born to Adult Participants | 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]) | 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. |
| Number of Neonates and Infants With AEs Leading to Study Discontinuation From Birth Until Study Discontinuation | 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}]) | 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. |
| Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528]) | 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. |
| Serological Response to Vaccination as Measured by VNA Titers at Birth (That is, in Cord Blood) in Neonates and Infants Born to Adult Participants | At Birth (PN Day 1 [Day 7 up to Day 163]) | 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. |
| Group 4: Number of Adult Participants With Solicited Systemic AEs for 7 Days Post Booster Vaccination | 7 days post booster vaccination (Day 84 up to Day 371) | 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. |
| Group 4: Number of Adult Participants With Unsolicited AEs for 28 Days Post Booster Vaccination | 28 days post booster vaccination (Day 84 up to Day 392) | 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. |
| Group 4: Number of Adult Participants With SAEs Post Booster Vaccination Until EOS | From booster vaccination (Day 84 up to Day 364) until EOS (up to PP Day 366 [Day 366 up to Day 554]) | 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. |
| Group 4: Number of Adult Participants With AESIs Post Booster Vaccination Until EOS | From booster vaccination (Day 84 up to Day 364) until EOS (up to PP Day 366 [Day 366 up to Day 554]) | 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. |
| Group 4: Number of Adult Participants With MAAEs Until 6 Months Post Booster Vaccination | 6 months post booster vaccination (Day 84 up to Day 546) | 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. |
| Group 4: Number of Adult Participants With AEs Leading to Study Discontinuation Post Booster Vaccination Until EOS | From post booster vaccination (Day 84 up to Day 364) until EOS (up to PP Day 366 [Day 366 up to Day 554]) | 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. |
| Number of Adult Participants With Pregnancy Outcomes | From first vaccination on Day 1 until PP Day 1 (Day 7 up to Day 163) | Number of adult participants with pregnancy outcomes were reported. Pregnancy outcomes in adult participants included live term birth, live preterm birth, stillbirth, and abortion. |
Countries
Brazil, South Africa, United States
Participant flow
Recruitment details
Per plan, only adults were considered enrolled in the study.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 10 |
| 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). | 29 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| 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 | Death | 0 | 0 | 0 | 1 | 0 | 0 |
| Post-natal: Neonates and Infants | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 5 |
| Post-natal: Neonates and Infants | Withdrawal by Parent Or Guardian | 0 | 0 | 0 | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Total |
|---|---|---|---|---|
| Age, Continuous | 24.3 years STANDARD_DEVIATION 3.42 | 24.2 years STANDARD_DEVIATION 3.61 | 25.4 years STANDARD_DEVIATION 5.29 | 24.9 years STANDARD_DEVIATION 4.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 6 Participants | 10 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 4 Participants | 18 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 8 Participants | 3 Participants | 18 Participants | 29 Participants |
| Region of Enrollment Brazil | 12 Participants | 9 Participants | 11 Participants | 32 Participants |
| Region of Enrollment South Africa | 0 Participants | 1 Participants | 4 Participants | 5 Participants |
| Region of Enrollment United States | 0 Participants | 0 Participants | 14 Participants | 14 Participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 29 Participants | 51 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 10 | 0 / 29 | 1 / 10 | 0 / 8 | 0 / 29 |
| other Total, other adverse events | 12 / 12 | 8 / 10 | 27 / 29 | 7 / 10 | 5 / 8 | 15 / 29 |
| serious Total, serious adverse events | 4 / 12 | 2 / 10 | 3 / 29 | 3 / 10 | 4 / 8 | 4 / 29 |
Outcome results
Primary
Number of Adult Participants With Adverse Events of Special Interest (AESIs) From First Vaccination Until EOS
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Adverse Events of Special Interest (AESIs) From First Vaccination Until EOS | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Adverse Events of Special Interest (AESIs) From First Vaccination Until EOS | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Adverse Events of Special Interest (AESIs) From First Vaccination Until EOS | 0 Participants |
Primary
Number of Adult Participants With AEs Leading to Study Discontinuation
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With AEs Leading to Study Discontinuation | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With AEs Leading to Study Discontinuation | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With AEs Leading to Study Discontinuation | 0 Participants |
Primary
Number of Adult Participants With Medically Attended Adverse Events (MAAEs) Until 6 Months Post First Vaccination
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Medically Attended Adverse Events (MAAEs) Until 6 Months Post First Vaccination | 6 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Medically Attended Adverse Events (MAAEs) Until 6 Months Post First Vaccination | 2 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Medically Attended Adverse Events (MAAEs) Until 6 Months Post First Vaccination | 7 Participants |
Primary
Number of Adult Participants With Serious Adverse Events (SAEs) From First Vaccination Until End of the Study (EOS)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Serious Adverse Events (SAEs) From First Vaccination Until End of the Study (EOS) | 4 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Serious Adverse Events (SAEs) From First Vaccination Until End of the Study (EOS) | 2 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Serious Adverse Events (SAEs) From First Vaccination Until End of the Study (EOS) | 3 Participants |
Primary
Number of Adult Participants With Solicited Local Adverse Events (AEs) for 7 Days Post First Vaccination
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Solicited Local Adverse Events (AEs) for 7 Days Post First Vaccination | 10 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Solicited Local Adverse Events (AEs) for 7 Days Post First Vaccination | 5 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Solicited Local Adverse Events (AEs) for 7 Days Post First Vaccination | 20 Participants |
Primary
Number of Adult Participants With Solicited Systemic AEs for 7 Days Post First Vaccination
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Solicited Systemic AEs for 7 Days Post First Vaccination | 10 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Solicited Systemic AEs for 7 Days Post First Vaccination | 4 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Solicited Systemic AEs for 7 Days Post First Vaccination | 20 Participants |
Primary
Number of Adult Participants With Unsolicited AEs for 28 Days Post First Vaccination
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Unsolicited AEs for 28 Days Post First Vaccination | 7 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Unsolicited AEs for 28 Days Post First Vaccination | 4 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Unsolicited AEs for 28 Days Post First Vaccination | 10 Participants |
Primary
Serological Response to Vaccination as Measured by S-Enzyme-linked Immunosorbent Assay (S-ELISA) in Adult Participants 28 Days Post First Vaccination
Serological response to vaccination as measured by S-ELISA in adult participants 28 days post first vaccination was reported.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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) |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Serological Response to Vaccination as Measured by S-Enzyme-linked Immunosorbent Assay (S-ELISA) in Adult Participants 28 Days Post First Vaccination | 12335 ELISA units per milliliter (EU/mL) |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Serological Response to Vaccination as Measured by S-Enzyme-linked Immunosorbent Assay (S-ELISA) in Adult Participants 28 Days Post First Vaccination | 5906 ELISA units per milliliter (EU/mL) |
Secondary
Group 4: Number of Adult Participants With AESIs Post Booster Vaccination Until EOS
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Group 4: Number of Adult Participants With AESIs Post Booster Vaccination Until EOS | 0 Participants |
Secondary
Group 4: Number of Adult Participants With AEs Leading to Study Discontinuation Post Booster Vaccination Until EOS
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Group 4: Number of Adult Participants With AEs Leading to Study Discontinuation Post Booster Vaccination Until EOS | 0 Participants |
Secondary
Group 4: Number of Adult Participants With MAAEs Until 6 Months Post 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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Group 4: Number of Adult Participants With MAAEs Until 6 Months Post Booster Vaccination | 0 Participants |
Secondary
Group 4: Number of Adult Participants With SAEs Post Booster Vaccination Until EOS
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Group 4: Number of Adult Participants With SAEs Post Booster Vaccination Until EOS | 0 Participants |
Secondary
Group 4: Number of Adult Participants With Solicited Local AEs for 7 Days Post 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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Group 4: Number of Adult Participants With Solicited Local AEs for 7 Days Post Booster Vaccination | 6 Participants |
Secondary
Group 4: Number of Adult Participants With Solicited Systemic AEs for 7 Days Post 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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Group 4: Number of Adult Participants With Solicited Systemic AEs for 7 Days Post Booster Vaccination | 7 Participants |
Secondary
Group 4: Number of Adult Participants With Unsolicited AEs for 28 Days Post 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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Group 4: Number of Adult Participants With Unsolicited AEs for 28 Days Post Booster Vaccination | 2 Participants |
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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) |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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) |
Secondary
Group 4: Serological Response to Booster Vaccination Measured by Neutralizing (VNA) Antibody Titers in Adult Participants at Blood Collection Time Points Post 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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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 |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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 |
Secondary
Number of Adult Participants With Pregnancy Outcomes
Number of adult participants with pregnancy outcomes were reported. Pregnancy outcomes in adult participants included live term birth, live preterm birth, stillbirth, and abortion.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Live Term Birth | 10 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Live Preterm Birth | 0 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Stillbirth | 0 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Abortion | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Abortion | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Live Term Birth | 7 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Stillbirth | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Live Preterm Birth | 1 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Abortion | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Live Preterm Birth | 3 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Stillbirth | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Outcomes | Live Term Birth | 26 Participants |
Secondary
Number of Adult Participants With Pregnancy Related AEs Throughout Pregnancy
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Related AEs Throughout Pregnancy | Gestational Age: 16-27 weeks | 4 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Related AEs Throughout Pregnancy | Gestational Age: 28-38 weeks | 1 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Related AEs Throughout Pregnancy | Gestational Age: 16-27 weeks | 2 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Related AEs Throughout Pregnancy | Gestational Age: 28-38 weeks | 3 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Related AEs Throughout Pregnancy | Gestational Age: 16-27 weeks | 3 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Adult Participants With Pregnancy Related AEs Throughout Pregnancy | Gestational Age: 28-38 weeks | 1 Participants |
Secondary
Number of Neonates and Infants With AESIs From Birth Until 12 Months of Age in Neonates and Infants Born to 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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With AESIs From Birth Until 12 Months of Age in Neonates and Infants Born to Adult Participants | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With AESIs From Birth Until 12 Months of Age in Neonates and Infants Born to Adult Participants | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With AESIs From Birth Until 12 Months of Age in Neonates and Infants Born to Adult Participants | 0 Participants |
Secondary
Number of Neonates and Infants With AEs Leading to Study Discontinuation From Birth Until Study Discontinuation
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With AEs Leading to Study Discontinuation From Birth Until Study Discontinuation | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With AEs Leading to Study Discontinuation From Birth Until Study Discontinuation | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With AEs Leading to Study Discontinuation From Birth Until Study Discontinuation | 0 Participants |
Secondary
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
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.
Time frame: From birth (PN Day 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Preterm neonate without complications | 0 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Term neonate with complications | 0 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Preterm neonate with complications | 0 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Neonatal infection | 0 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Respiratory distress | 0 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Congenital anomalies | 0 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Neonatal death | 0 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Low birth weight | 1 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Small for gestational age | 0 Participants |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Normal neonate | 9 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Congenital anomalies | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Normal neonate | 7 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Respiratory distress | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Preterm neonate without complications | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Term neonate with complications | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Small for gestational age | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Low birth weight | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Preterm neonate with complications | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Neonatal death | 0 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Neonatal infection | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Low birth weight | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Neonatal infection | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Preterm neonate without complications | 2 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Respiratory distress | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Congenital anomalies | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Small for gestational age | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Neonatal death | 0 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Normal neonate | 25 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Term neonate with complications | 1 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age | Preterm neonate with complications | 1 Participants |
Secondary
Number of Neonates and Infants With MAAEs From Birth Until 6 Months of Age in Neonates and Infants Born to 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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With MAAEs From Birth Until 6 Months of Age in Neonates and Infants Born to Adult Participants | 5 Participants |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With MAAEs From Birth Until 6 Months of Age in Neonates and Infants Born to Adult Participants | 4 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Number of Neonates and Infants With MAAEs From Birth Until 6 Months of Age in Neonates and Infants Born to Adult Participants | 5 Participants |
Secondary
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
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.
Time frame: From birth (PN Day 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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 |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | 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 | 4 Participants |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | 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 | 4 Participants |
Secondary
Serological Response to First Vaccination as Measured by S-ELISA in Adult Participants at All Blood Collection Timepoints Post First Vaccination
Serological response to first vaccination as measured by S-ELISA at all blood collection timepoints post first vaccination were reported.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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) |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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) |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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) |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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) |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | 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) | 8846 ELISA Units per milliliter (EU/mL) |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Serological Response to First Vaccination as Measured by S-ELISA in Adult Participants at All Blood Collection Timepoints Post First Vaccination | Day 1 | 2927 ELISA Units per milliliter (EU/mL) |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | 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) | 10179 ELISA Units per milliliter (EU/mL) |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Serological Response to First Vaccination as Measured by S-ELISA in Adult Participants at All Blood Collection Timepoints Post First Vaccination | Day 29 | 12335 ELISA Units per milliliter (EU/mL) |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | 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) | 4698 ELISA Units per milliliter (EU/mL) |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Serological Response to First Vaccination as Measured by S-ELISA in Adult Participants at All Blood Collection Timepoints Post First Vaccination | Day 29 | 5906 ELISA Units per milliliter (EU/mL) |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | 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) | 4025 ELISA Units per milliliter (EU/mL) |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Serological Response to First Vaccination as Measured by S-ELISA in Adult Participants at All Blood Collection Timepoints Post First Vaccination | Day 1 | 197 ELISA Units per milliliter (EU/mL) |
Secondary
Serological Response to First Vaccination as Measured by Virus Neutralization Assay (VNA) Titers, 28 Days in Adult Participants Post First Vaccination
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.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | Serological Response to First Vaccination as Measured by Virus Neutralization Assay (VNA) Titers, 28 Days in Adult Participants Post First Vaccination | 7233 titers |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Serological Response to First Vaccination as Measured by Virus Neutralization Assay (VNA) Titers, 28 Days in Adult Participants Post First Vaccination | 5527 titers |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Serological Response to First Vaccination as Measured by Virus Neutralization Assay (VNA) Titers, 28 Days in Adult Participants Post First Vaccination | 1601 titers |
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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) |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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) |
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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) |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | 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]) | 3520 ELISA Units per milliliter (EU/mL) |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | 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]) | 11540 ELISA Units per milliliter (EU/mL) |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | 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) | 477 ELISA Units per milliliter (EU/mL) |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | 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]) | 4013 ELISA Units per milliliter (EU/mL) |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | 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) | 795 ELISA Units per milliliter (EU/mL) |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | 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]) | 2996 ELISA Units per milliliter (EU/mL) |
Secondary
Serological Response to Vaccination as Measured by VNA Titers at Birth (That is, in Cord Blood) in Neonates and Infants Born to Adult Participants
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.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 (Adults): Ad26.COV2.S 5*10^10 vp | 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 |
| Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp | Serological Response to Vaccination as Measured by VNA Titers at Birth (That is, in Cord Blood) in Neonates and Infants Born to Adult Participants | 3756 titers |
| Group 4 (Adults): Vaccine-naive: Ad26.COV2.S 5*10^10 vp | Serological Response to Vaccination as Measured by VNA Titers at Birth (That is, in Cord Blood) in Neonates and Infants Born to Adult Participants | 658 titers |