COVID-19 Prevention
Conditions
Brief summary
The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S.
Interventions
BIOLOGICALAd26.COV2.S
Participants will receive intramuscular (IM) injections of Ad26.COV2.S.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study * Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe Coronavirus disease 2019 (COVID-19), except for smoking, which is allowed. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participant will be included on the basis of physical examination, medical history, and vital signs * All female participants of childbearing potential must: a) have a negative highly sensitive urine pregnancy test at screening; b) have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration * 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
Exclusion criteria
* Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0 degree Celsius (C) (100.4 degree Fahrenheit \[F\]) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor * 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 received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccinations; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccinations * Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study * Participant previously received a coronavirus vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination | 28 days after first vaccination (at Day 29) | Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. |
| Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination | 14 days after second vaccination (at Day 71) | Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64]) | An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participant in their e-diary for 7 days after each vaccination. Solicited local AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. |
| Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64]) | An AE was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) were noted in the subject diary after 7 days of each vaccination. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. |
| Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | 28 days after each vaccination (first vaccination [at Day 29], second vaccination [at Day 85]) | Unsolicited AEs were all AEs for which the subject was not specifically questioned in the subject diary. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. |
| Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 29, Day 57, Day 71, Week 32, and Week 60 | Percentage of participants with serological response to vaccination to SARS-COV-2 S protein as measured by ELISA were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) the baseline (pre-dose 1) sample value was less than or equal to (\<=) lower limit of quantification (LLOQ) and the post-baseline sample was greater than (\>) LLOQ; (2) the baseline sample (pre-dose 1) value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>=4-fold) increase from the baseline sample value. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. |
| Number of Participants With Adverse Events of Special Interest (AESIs) | From Day 1 (post-vaccination) up to end of the study (up to 60 weeks) | AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome were considered to be an AESI. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. |
| Number of Participants With AEs Leading to Study Discontinuation | Up to 60 weeks | Number of participants with AEs leading to study discontinuation were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. |
| Number of Participants With Medically-Attended Adverse Events (MAAEs) | 6 months after second vaccination (up to 32 weeks) | 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. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. |
| Number of Participants With Serious Adverse Events (SAEs) | From Day 1 (post-vaccination) up to end of the study (up to 60 weeks) | SAE was any untoward medical occurrence that at any dose may results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. |
| Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 29, Day 57, Day 71, Week 32, and Week 60 | Geometric mean concentration of SARS-CoV-2 S protein binding antibody measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. |
Countries
Brazil, Germany, Poland, South Africa, United States
Participant flow
Recruitment details
A total of 1609 participants were enrolled, but 1 participant was randomized by error. This participant was never treated and was removed from the randomized list.
Pre-assignment details
As planned, the Participant flow, baseline characteristics, Outcome measures data and adverse events data were analyzed and reported combined for the main study and sub-study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57. | 288 |
| Group 2: Ad26.COV2.S 7x10^10 vp Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57. | 221 |
| Group 3: Ad26.COV2.S 5x10^10 vp Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57. | 291 |
| Group 4: Ad26.COV2.S 3.5x10^10 vp Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57. | 220 |
| Group 5: Ad26.COV2.S 2.5x10^10 vp Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57. | 288 |
| Group 6: Ad26.COV2.S 1.25x10^10 vp Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57. | 285 |
| Total | 1,593 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Initiated prohibited medication | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 33 | 33 | 36 | 30 | 32 | 34 |
| Overall Study | Other | 3 | 1 | 3 | 2 | 4 | 1 |
| Overall Study | Physician Decision | 1 | 1 | 1 | 2 | 0 | 0 |
| Overall Study | Protocol deviation | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Randomized but not vaccinated | 3 | 1 | 2 | 2 | 3 | 4 |
| Overall Study | Withdrawal by Subject | 12 | 8 | 7 | 6 | 12 | 14 |
Baseline characteristics
| Characteristic | Total | Group 6: Ad26.COV2.S 1.25x10^10 vp | Group 1: Ad26.COV2.S 9x10^10 vp | Group 5: Ad26.COV2.S 2.5x10^10 vp | Group 4: Ad26.COV2.S 3.5x10^10 vp | Group 3: Ad26.COV2.S 5x10^10 vp | Group 2: Ad26.COV2.S 7x10^10 vp |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 34.7 years STANDARD_DEVIATION 9.81 | 33.4 years STANDARD_DEVIATION 9.63 | 35.6 years STANDARD_DEVIATION 10.21 | 34.5 years STANDARD_DEVIATION 9.81 | 34.7 years STANDARD_DEVIATION 9.36 | 34.8 years STANDARD_DEVIATION 9.82 | 35.2 years STANDARD_DEVIATION 9.87 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adults (18-64 years) | 1593 Participants | 285 Participants | 288 Participants | 288 Participants | 220 Participants | 291 Participants | 221 Participants |
| Age, Customized From 65 to 84 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 682 Participants | 130 Participants | 132 Participants | 121 Participants | 87 Participants | 129 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 779 Participants | 135 Participants | 130 Participants | 137 Participants | 116 Participants | 138 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 132 Participants | 20 Participants | 26 Participants | 30 Participants | 17 Participants | 24 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 4 Participants | 3 Participants | 2 Participants | 3 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 502 Participants | 101 Participants | 104 Participants | 87 Participants | 63 Participants | 90 Participants | 57 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 2 Participants | 2 Participants | 3 Participants | 4 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 86 Participants | 15 Participants | 16 Participants | 12 Participants | 11 Participants | 15 Participants | 17 Participants |
| Race (NIH/OMB) White | 961 Participants | 163 Participants | 161 Participants | 183 Participants | 138 Participants | 174 Participants | 142 Participants |
| Region of Enrollment Brazil | 811 Participants | 142 Participants | 155 Participants | 146 Participants | 104 Participants | 152 Participants | 112 Participants |
| Region of Enrollment Germany | 368 Participants | 65 Participants | 56 Participants | 59 Participants | 65 Participants | 64 Participants | 59 Participants |
| Region of Enrollment South Africa | 122 Participants | 24 Participants | 22 Participants | 24 Participants | 13 Participants | 25 Participants | 14 Participants |
| Region of Enrollment United States | 292 Participants | 54 Participants | 55 Participants | 59 Participants | 38 Participants | 50 Participants | 36 Participants |
| Sex/Gender, Customized Female | 590 Participants | 103 Participants | 117 Participants | 106 Participants | 72 Participants | 119 Participants | 73 Participants |
| Sex/Gender, Customized Male | 1002 Participants | 182 Participants | 170 Participants | 182 Participants | 148 Participants | 172 Participants | 148 Participants |
| Sex/Gender, Customized Undifferentiated | 1 Participants | 0 Participants | 1 Participants | 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 | 1 / 288 | 0 / 221 | 0 / 291 | 0 / 220 | 0 / 288 | 1 / 285 |
| other Total, other adverse events | 245 / 288 | 187 / 221 | 236 / 291 | 188 / 220 | 228 / 288 | 217 / 285 |
| serious Total, serious adverse events | 13 / 288 | 3 / 221 | 4 / 291 | 4 / 220 | 3 / 288 | 5 / 285 |
Outcome results
Primary
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Time frame: 14 days after second vaccination (at Day 71)
Population: The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination | 4997 ELISA Units per millilitre (EU/mL) |
| Group 2: Ad26.COV2.S 7x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination | 3757 ELISA Units per millilitre (EU/mL) |
| Group 3: Ad26.COV2.S 5x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination | 3855 ELISA Units per millilitre (EU/mL) |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination | 3460 ELISA Units per millilitre (EU/mL) |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination | 3641 ELISA Units per millilitre (EU/mL) |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination | 3905 ELISA Units per millilitre (EU/mL) |
Comparison: Group 1 (2 doses) vs Group 3 (1 dose)97.5% CI: [1.992, 3.207]
Comparison: Group 1 (2 doses) vs Group 3 (2 doses)97.5% CI: [1.088, 1.815]
Comparison: Group 5 (2 doses) vs Group 3 (1 dose)97.5% CI: [1.408, 2.265]
Comparison: Group 5 (2 doses) vs Group 3 (2 doses)97.5% CI: [0.769, 1.282]
Comparison: Group 2 (2 doses) vs Group 3 (1 dose)97.5% CI: [1.829, 3.007]
Comparison: Group 2 (2 doses) vs Group 3 (2 doses)97.5% CI: [1, 1.739]
Comparison: Group 4 (2 doses) vs Group 3 (1 dose)97.5% CI: [1.697, 2.841]
Comparison: Group 4 (2 doses) vs Group 3 (2 doses)97.5% CI: [0.928, 1.606]
Comparison: Group 6 (2 doses) vs Group 3 (1 dose)97.5% CI: [1.348, 2.148]
Comparison: Group 6 (2 doses) vs Group 3 (2 doses)97.5% CI: [0.736, 1.217]
Primary
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Time frame: 28 days after first vaccination (at Day 29)
Population: The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analysed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination | 2351 ELISA Units per millilitre (EU/mL) |
| Group 2: Ad26.COV2.S 7x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination | 1714 ELISA Units per millilitre (EU/mL) |
| Group 3: Ad26.COV2.S 5x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination | 2189 ELISA Units per millilitre (EU/mL) |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination | 1377 ELISA Units per millilitre (EU/mL) |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination | 1626 ELISA Units per millilitre (EU/mL) |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination | 1976 ELISA Units per millilitre (EU/mL) |
Comparison: Group 1 (1 dose) vs Group 3 (1 dose)97.5% CI: [0.926, 1.44]
Comparison: Group 5 (1 dose) vs Group 3 (1 dose)97.5% CI: [0.641, 1]
Comparison: Group 2 (1 dose) vs Group 3 (1 dose)97.5% CI: [0.844, 1.356]
Comparison: Group 4 (1 dose) vs Group 3 (1 dose)97.5% CI: [0.742, 1.193]
Comparison: Group 6 (1 dose) vs Group 3 (1 dose)97.5% CI: [0.648, 1.007]
Secondary
Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
Geometric mean concentration of SARS-CoV-2 S protein binding antibody measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Time frame: Day 29, Day 57, Day 71, Week 32, and Week 60
Population: The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 32 | 3331 ELISA Unit (EU)/mL |
| Group 1: Ad26.COV2.S 9x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 57 | 2722 ELISA Unit (EU)/mL |
| Group 1: Ad26.COV2.S 9x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 29 | 2351 ELISA Unit (EU)/mL |
| Group 1: Ad26.COV2.S 9x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 60 | 4968 ELISA Unit (EU)/mL |
| Group 1: Ad26.COV2.S 9x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 71 | 4997 ELISA Unit (EU)/mL |
| Group 2: Ad26.COV2.S 7x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 57 | 1842 ELISA Unit (EU)/mL |
| Group 2: Ad26.COV2.S 7x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 32 | 2903 ELISA Unit (EU)/mL |
| Group 2: Ad26.COV2.S 7x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 29 | 1714 ELISA Unit (EU)/mL |
| Group 2: Ad26.COV2.S 7x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 60 | 5010 ELISA Unit (EU)/mL |
| Group 2: Ad26.COV2.S 7x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 71 | 3757 ELISA Unit (EU)/mL |
| Group 3: Ad26.COV2.S 5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 57 | 2089 ELISA Unit (EU)/mL |
| Group 3: Ad26.COV2.S 5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 32 | 2616 ELISA Unit (EU)/mL |
| Group 3: Ad26.COV2.S 5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 60 | 2363 ELISA Unit (EU)/mL |
| Group 3: Ad26.COV2.S 5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 71 | 3855 ELISA Unit (EU)/mL |
| Group 3: Ad26.COV2.S 5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 29 | 2189 ELISA Unit (EU)/mL |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 71 | 3460 ELISA Unit (EU)/mL |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 29 | 1377 ELISA Unit (EU)/mL |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 57 | 1622 ELISA Unit (EU)/mL |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 32 | 2059 ELISA Unit (EU)/mL |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 60 | 2191 ELISA Unit (EU)/mL |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 32 | 3067 ELISA Unit (EU)/mL |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 29 | 1626 ELISA Unit (EU)/mL |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 60 | 2769 ELISA Unit (EU)/mL |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 57 | 1919 ELISA Unit (EU)/mL |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 71 | 3641 ELISA Unit (EU)/mL |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 29 | 1976 ELISA Unit (EU)/mL |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 32 | 2707 ELISA Unit (EU)/mL |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 57 | 2293 ELISA Unit (EU)/mL |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Week 60 | 3664 ELISA Unit (EU)/mL |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA | Day 71 | 3905 ELISA Unit (EU)/mL |
Secondary
Number of Participants With Adverse Events of Special Interest (AESIs)
AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome were considered to be an AESI. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Time frame: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Population: Full analysis set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
Secondary
Number of Participants With AEs Leading to Study Discontinuation
Number of participants with AEs leading to study discontinuation were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Time frame: Up to 60 weeks
Population: Full analysis set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp | Number of Participants With AEs Leading to Study Discontinuation | 0 Participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Number of Participants With AEs Leading to Study Discontinuation | 0 Participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Number of Participants With AEs Leading to Study Discontinuation | 0 Participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Number of Participants With AEs Leading to Study Discontinuation | 0 Participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Number of Participants With AEs Leading to Study Discontinuation | 0 Participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Number of Participants With AEs Leading to Study Discontinuation | 0 Participants |
Secondary
Number of Participants With Medically-Attended Adverse Events (MAAEs)
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. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Time frame: 6 months after second vaccination (up to 32 weeks)
Population: Full analysis set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp | Number of Participants With Medically-Attended Adverse Events (MAAEs) | 54 Participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Number of Participants With Medically-Attended Adverse Events (MAAEs) | 34 Participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Number of Participants With Medically-Attended Adverse Events (MAAEs) | 50 Participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Number of Participants With Medically-Attended Adverse Events (MAAEs) | 35 Participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Number of Participants With Medically-Attended Adverse Events (MAAEs) | 48 Participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Number of Participants With Medically-Attended Adverse Events (MAAEs) | 35 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
SAE was any untoward medical occurrence that at any dose may results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Time frame: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Population: Full analysis set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp | Number of Participants With Serious Adverse Events (SAEs) | 13 Participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Number of Participants With Serious Adverse Events (SAEs) | 4 Participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Number of Participants With Serious Adverse Events (SAEs) | 4 Participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Number of Participants With Serious Adverse Events (SAEs) | 5 Participants |
Secondary
Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
Unsolicited AEs were all AEs for which the subject was not specifically questioned in the subject diary. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Time frame: 28 days after each vaccination (first vaccination [at Day 29], second vaccination [at Day 85])
Population: Full analysis set included all participants with at least one vaccine administration documented. Here, 'n' (number of participants analyzed) signifies number of participants evaluable for this timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After first vaccination | 78 Participants |
| Group 1: Ad26.COV2.S 9x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After second vaccination | 55 Participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After first vaccination | 60 Participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After second vaccination | 28 Participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After second vaccination | 49 Participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After first vaccination | 55 Participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After first vaccination | 58 Participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After second vaccination | 39 Participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After first vaccination | 69 Participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After second vaccination | 53 Participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After second vaccination | 50 Participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | After first vaccination | 59 Participants |
Secondary
Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination
An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participant in their e-diary for 7 days after each vaccination. Solicited local AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Time frame: 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
Population: Full analysis set included all participants with at least one vaccine administration documented. Here, 'n' (number of participants analyzed) signifies number of participants evaluable for this timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After first vaccination | 179 Participants |
| Group 1: Ad26.COV2.S 9x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After second vaccination | 130 Participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After first vaccination | 143 Participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After second vaccination | 100 Participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After first vaccination | 162 Participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After second vaccination | 124 Participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After first vaccination | 137 Participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After second vaccination | 95 Participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After first vaccination | 155 Participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After second vaccination | 111 Participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After first vaccination | 133 Participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination | After second vaccination | 104 Participants |
Secondary
Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination
An AE was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) were noted in the subject diary after 7 days of each vaccination. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Time frame: 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
Population: Full analysis set included all participants with at least one vaccine administration documented. Here, 'n' (number of subjects analysed) signifies number of subjects evaluable for this timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After first vaccination | 204 Participants |
| Group 1: Ad26.COV2.S 9x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After second vaccination | 144 Participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After first vaccination | 156 Participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After second vaccination | 98 Participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After first vaccination | 173 Participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After second vaccination | 111 Participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After first vaccination | 135 Participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After second vaccination | 91 Participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After first vaccination | 156 Participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After second vaccination | 105 Participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After first vaccination | 152 Participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination | After second vaccination | 109 Participants |
Secondary
Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
Percentage of participants with serological response to vaccination to SARS-COV-2 S protein as measured by ELISA were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) the baseline (pre-dose 1) sample value was less than or equal to (\<=) lower limit of quantification (LLOQ) and the post-baseline sample was greater than (\>) LLOQ; (2) the baseline sample (pre-dose 1) value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>=4-fold) increase from the baseline sample value. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Time frame: Day 29, Day 57, Day 71, Week 32, and Week 60
Population: The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 9x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 32 | 72.3 Percentage of participants |
| Group 1: Ad26.COV2.S 9x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 57 | 81.9 Percentage of participants |
| Group 1: Ad26.COV2.S 9x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 29 | 82.7 Percentage of participants |
| Group 1: Ad26.COV2.S 9x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 60 | 68.9 Percentage of participants |
| Group 1: Ad26.COV2.S 9x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 71 | 81.9 Percentage of participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 57 | 88.6 Percentage of participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 32 | 83.7 Percentage of participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 29 | 90.1 Percentage of participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 60 | 81.8 Percentage of participants |
| Group 2: Ad26.COV2.S 7x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 71 | 92.3 Percentage of participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 57 | 80.2 Percentage of participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 32 | 68.0 Percentage of participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 60 | 61.9 Percentage of participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 71 | 79.4 Percentage of participants |
| Group 3: Ad26.COV2.S 5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 29 | 78.8 Percentage of participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 71 | 91.8 Percentage of participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 29 | 87.8 Percentage of participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 57 | 92.0 Percentage of participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 32 | 86.7 Percentage of participants |
| Group 4: Ad26.COV2.S 3.5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 60 | 83.8 Percentage of participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 32 | 68.6 Percentage of participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 29 | 80.2 Percentage of participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 60 | 60.0 Percentage of participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 57 | 81.3 Percentage of participants |
| Group 5: Ad26.COV2.S 2.5x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 71 | 80.8 Percentage of participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 29 | 76.1 Percentage of participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 32 | 63.2 Percentage of participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 57 | 77.7 Percentage of participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Week 60 | 53.8 Percentage of participants |
| Group 6: Ad26.COV2.S 1.25x10^10 vp | Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA | Day 71 | 76.1 Percentage of participants |