Healthy
Conditions
Brief summary
The primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination; safety and reactogenicity of Ad26.COV2.S administered IM as a 2-dose or a single-dose schedule in adults (18-65 years or older) and to assess the safety and reactogenicity of Ad26.COV2.S, administered IM as single dose in adolescents (12-17 years) and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart) in adults (18-55 years and 65 years or older).
Detailed description
The aim of the COVID-19 vaccine clinical development program is to develop a safe and effective vaccine for the prevention of COVID-19. Currently, there is only limited availability of authorized/licensed vaccines for the prevention of coronavirus disease-2019 (COVID-19). 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 severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus spike (S) protein, which will be assessed in this study. Also, different vaccination intervals and multiple lower dose levels compared to the dose levels in the first in human study (VAC31518COV1001 \[NCT04436276\]) will be assessed. For adults, the study consists of: screening phase (28 days), vaccination phase (1-3 months) depending on the vaccination interval, and follow-up (12 months). The study duration is approximately 15 months (Groups 1-6, 8, 10 and Group 7 \[to participants for whom vaccination 2 was delayed\]), 14 months (Group 7), and 16 months (Group 9) in adult groups and approximately 13 months for adolescents group (Groups A to C). The adverse events and other safety assessments including vital signs measurements (heart rate, supine systolic and diastolic blood pressure, respiratory rate, and body temperature), and physical examinations will be assessed during the study. Note: The Informed Consent Form dated 27-Oct-2020 is final version of the study MASTER ICF, used by local countries to prepare the local language version of the ICF, which have been approved by the Ethics Committees. And the highlighted text in the ICF document are the guidance for country specific adaptation.
Interventions
BIOLOGICALAd26.COV2.S
All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.
OTHERPlacebo
Adult participants in Groups 4, 5, 6, 8, and 10, and adolescent participants in Group C will receive at least one injection of placebo.
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
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For Adults * Participant must have a body mass index (BMI) less than (\<) 30.0 kilogram per meter square (kg/m\^2) * Participant is 18 to 55 years of age, inclusive, or 65 years of age or older on the day of signing the informed consent form (ICF). * Participant 18 to 55 years of age, inclusive: participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (COVID-19), except for smoking and mild hypertension, which are allowed. Participant 65 years of age and older: In the investigator's clinical judgment, participant must be either in good or stable health. 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 COVID-19, except for smoking and mild hypertension, which are 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 * Participant will be included on the basis of physical examination, medical history, and vital signs * All 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 For Adolescents: * Participant is 12 to 17 years of age, inclusive, on the day of signing the informed consent form (ICF) * Participants must have signed an ICF (or their legally acceptable representative or parent(s) \[preferably both parents if available or as per local requirements\] must sign) indicating that they understand the purpose of, and procedures required for, the study, are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures, and are willing (or the parents are willing for their adolescent) to participate in the study. Informed assent must be obtained from adolescents, depending on local regulations and practice * Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe COVID-19
Exclusion criteria
For Adults * 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 history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is 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 received treatment with immunoglobulins in the 3 months or blood products in the 4 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study * 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 Ig or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) 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 For Adolescents * 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) * Participants with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the participant if he/she participates in the study * Participant has a history of Kawasaki disease * Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adolescents: Number of Participants With AESIs | Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years) | AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter. |
| Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2 | 28 days after Vaccination 2 (Day 85) | Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively. |
| Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2 | 28 days after Vaccination 2 (Day 85) | Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported. |
| Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers at 28 Days After Vaccination 1 | 28 days after Vaccination 1 (Day 29) | Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively. |
| Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1 | 28 days after Vaccination 1 (Day 29) | Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively. |
| Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 | 28 days after Vaccination 1 (Day 29) | Antibody GMTs as measured by VNA at 28 days after vaccination 1 were reported. LLOQ was 58 IU/mL. |
| Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1 | 28 days after Vaccination 1 (Day 29) | Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 1 were reported. The LLOQ was 50.3 IU/mL. |
| Adults of Groups 9 and 10: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 2 | 28 days after Vaccination 2 ( Day 113) | Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively. |
| Adults of Groups 9 and 10: Percentage of Participant With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 2 | 28 days after Vaccination 2 (Day 113) | Percentage of participant with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively. |
| Adults of Groups 9 and 10: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 2 | 28 days after Vaccination 2 (Day 113) | Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported. The LLOQ was 58 IU/mL. |
| Adults of Groups 9 and 10: Antibody GMCs as Measured by S-ELISA at 28 Days After Vaccination 2 | 28 Days after Vaccination 2 (Day 113) | Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported. The LLOQ was 50.3 IU/mL. |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1 | 7 days after Vaccination 1 (Day 8) | Number of participants with solicited local AEs at 7 days after vaccination 1 were reported. 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 participants in their e-diary for 7 days after vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 | 7 days after Vaccination 1 (Day 8) | Number of participants with solicited systemic AEs at 7 days after vaccination 1 were reported. 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius). |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2 | 7 days after Vaccination 2 (Day 64 for Groups 1-6; Day 92 for Groups 9 and 10) | Number of participants with solicited local AEs at 7 days after vaccination 2 were reported. 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 participants in their e-diary for 7 days post vaccination 2 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2 | 7 days after Vaccination 2 (Day 64 for Group 1-6; Day 92 for Group 9 and 10) | Number of participants with solicited systemic AEs at 7 days after vaccination 2 were reported. 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 2 (Day of vaccination 2 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius). |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 28 days after Vaccination 1 (Day 29) | Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2 | 28 days After Vaccination 2 (Day 85 for Groups 1-6; Day 113 for Groups 9 and 10) | Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs) | Up to 1.5 years | SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs) | Up to 1.5 years | AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter. |
| Adolescents: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 1 | 7 Days After Vaccination 1 (Day 8) | Number of participants with solicited local AEs at 7 days after vaccination 1 were reported. 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 participants in their e-diary for 7 days post vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. |
| Adolescents: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 1 | 7 Days After Vaccination 1 (Day 8) | Number of participants with solicited systemic AEs at 7 days after vaccination 1 were reported. 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 1 (Day of vaccination1 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius). |
| Adolescents: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 28 Days After Vaccination 1 (Day 29) | Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. |
| Adolescents: Number of Participants With SAEs (Inclusive Multisystem Inflammatory Syndrome in Children [MIS-C]) | Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years) | SAE was any untoward medical occurrence that at any dose may result 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. |
| Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2 | 28 days after Vaccination 2 (Day 85) | Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported. |
| Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2 | 28 days after Vaccination 2 (Day 85) | Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was less than or equal to the lower limit of quantification (\<=LLOQ) and the post-baseline sample was greater than (\>) LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (greater than or equal to \[\>=\] 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were 50 percent (%) inhibitory concentration (IC50) of 58 and 12,800 international unit per milliliter (IU/mL) respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation | 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9) | Antibody GMTs as measured by VNA at 7 days after antigen presentation were reported. |
| Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9) | Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively. |
| Adults of Group 7: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | Day 148 | Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL. respectively. |
| Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation | 7 Days after Antigen Presentation (Day 176 for Groups 1-5; Day 204 for Group 9) | Antibody GMCs as measured by S-ELISA 7 days after antigen presentation were reported. |
| Adults of Group 7: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation | Day 148 | Antibody GMCs as measured by S-ELISA 7 days after antigen presentation were reported. |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation | 7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10) | Number of participants with solicited local AEs at 7 days after antigen presentation were reported. 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 participants in their e-diary for 7 days after antigen presentation (day of antigen presentation and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation | 7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10) | Number of participants with solicited systemic AEs at 7 days after antigen presentation were reported. 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days after antigen presentation (Day of antigen presentation and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius). |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation | 28 Days After Antigen Presentation (Day 197 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 225 for Group 9 and 10) | Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participants diary. |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation | After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10) | SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. |
| Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation | After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10) | AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter. |
| Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Days 197 and 393 | Percentage of participants with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported. |
| Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Days 225 and 421 | Percentage of participants with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported. |
| Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Days 197 and 393 | Percentage of participants with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported. |
| Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Days 225 and 421 | Percentage of participants with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported. |
| Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 (Day 29) | 28 Days After Vaccination 1 (Day 29) | Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively. |
| Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 28 Days After Vaccination 1 (Day 29) | 28 Days After Vaccination 1 (Day 29) | Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively. |
| Adolescents: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 | 28 days After Vaccination 1 (Day 29) | Antibody GMTs as measured by VNA at 28 days after vaccination 1 (Day 29) were reported. LLOQ was 58 IU/mL |
| Adolescents: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1 | 28 days After Vaccination 1 (Day 29) | Antibody GMCs as measured by S-ELISA 28 days after vaccination was reported. LLOQ was 58 IU/mL |
| Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA | Days 57, 85 and 169 | Neutralizing antibody titers to the Wild-type SARS-CoV-2 virus expressing S protein measured by VNA was reported. LLOQ was 58 IU/mL. |
| Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA | Days 57, 85, 169 | Binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins as measured by ELISA was reported. LLOQ was 58 IU/mL. |
| Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9) | Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively. |
| Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation | 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9) | Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL, respectively. |
Countries
Germany, Netherlands, Spain, United Kingdom
Participant flow
Pre-assignment details
A total of 635 participants were randomized, of which 617 were vaccinated and included in the analysis. As planned, combined data of Adolescents Groups A and B was collected and reported throughout the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen intramuscular (IM) injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 virus particles (vp) on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination. | 86 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination. | 81 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination. | 75 |
| Group 4: Ad26.COV2.S 1*10^11 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1\*10\^11 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination. | 74 |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination. | 81 |
| Group 6: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 57. Participants also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, Adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S 5\*10\^10 vp IM injection vaccine regimen at a 28-day interval. | 26 |
| Group 7: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 29. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination. | 56 |
| Group 8: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 29. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp. | 27 |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination. | 53 |
| Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp. | 25 |
| Group A and B Combined: Ad26.COV2.S 2.5*10^10 Adolescent participants aged 16 to 17 years received single dose IM injection of Ad26.COV2.S vaccine at a dose level of 2.5\*10\^10 vp on Day 1 in Groups A and B. | 30 |
| Group C: Placebo Adolescent participants aged 16 to 17 years received single dose IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1. At approximately 6 months of study participation, participants were unblinded and received vaccination 1 with Ad26.COV2.S 2.5\*10\^10 vp. | 3 |
| Total | 617 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 0 | 3 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 6 | 3 | 3 | 2 | 1 | 1 | 1 | 1 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Group 4: Ad26.COV2.S 1*10^11 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Group 6: Placebo, Placebo, Placebo | Group 7: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Group 8: Placebo, Placebo, Placebo | Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Group 10: Placebo, Placebo, Placebo | Group A and B Combined: Ad26.COV2.S 2.5*10^10 | Group C: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 47.4 years STANDARD_DEVIATION 18.81 | 49.1 years STANDARD_DEVIATION 19.44 | 49.1 years STANDARD_DEVIATION 18.12 | 49.2 years STANDARD_DEVIATION 17.33 | 50.3 years STANDARD_DEVIATION 17.1 | 48.6 years STANDARD_DEVIATION 18.5 | 48.4 years STANDARD_DEVIATION 16.88 | 48.8 years STANDARD_DEVIATION 17.15 | 49.0 years STANDARD_DEVIATION 17.63 | 48.1 years STANDARD_DEVIATION 18.99 | 52.4 years STANDARD_DEVIATION 13.63 | 16.3 years STANDARD_DEVIATION 0.47 | 16.3 years STANDARD_DEVIATION 0.58 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (16-17 years) | 33 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 30 Participants | 3 Participants |
| Age, Customized Adults (18-64 years) | 375 Participants | 48 Participants | 57 Participants | 52 Participants | 48 Participants | 51 Participants | 16 Participants | 37 Participants | 17 Participants | 33 Participants | 16 Participants | 0 Participants | 0 Participants |
| Age, Customized Children (2-11 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized From 65 to 84 years | 209 Participants | 33 Participants | 29 Participants | 23 Participants | 26 Participants | 30 Participants | 10 Participants | 19 Participants | 10 Participants | 20 Participants | 9 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 149 Participants | 22 Participants | 22 Participants | 20 Participants | 20 Participants | 22 Participants | 8 Participants | 14 Participants | 6 Participants | 9 Participants | 6 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 442 Participants | 56 Participants | 61 Participants | 51 Participants | 51 Participants | 58 Participants | 17 Participants | 40 Participants | 18 Participants | 41 Participants | 18 Participants | 29 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 26 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 4 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 598 Participants | 76 Participants | 83 Participants | 71 Participants | 73 Participants | 79 Participants | 25 Participants | 55 Participants | 27 Participants | 53 Participants | 24 Participants | 29 Participants | 3 Participants |
| Sex: Female, Male Female | 236 Participants | 30 Participants | 26 Participants | 22 Participants | 32 Participants | 35 Participants | 13 Participants | 14 Participants | 10 Participants | 19 Participants | 13 Participants | 20 Participants | 2 Participants |
| Sex: Female, Male Male | 381 Participants | 51 Participants | 60 Participants | 53 Participants | 42 Participants | 46 Participants | 13 Participants | 42 Participants | 17 Participants | 34 Participants | 12 Participants | 10 Participants | 1 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 141 | 1 / 81 | 0 / 75 | 0 / 74 | 0 / 81 | 0 / 52 | 0 / 1 | 0 / 1 | 0 / 53 | 0 / 25 | 0 / 30 | 0 / 3 |
| other Total, other adverse events | 35 / 141 | 24 / 81 | 20 / 75 | 20 / 74 | 33 / 81 | 11 / 52 | 0 / 1 | 0 / 1 | 16 / 53 | 9 / 25 | 11 / 30 | 2 / 3 |
| serious Total, serious adverse events | 7 / 141 | 1 / 81 | 1 / 75 | 1 / 74 | 2 / 81 | 0 / 52 | 0 / 1 | 0 / 1 | 1 / 53 | 0 / 25 | 0 / 30 | 0 / 3 |
Outcome results
Primary
Adolescents: Number of Participants With 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 (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Time frame: Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Number of Participants With AESIs | 0 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Number of Participants With AESIs | 0 Participants |
Primary
Adolescents: Number of Participants With SAEs (Inclusive Multisystem Inflammatory Syndrome in Children [MIS-C])
SAE was any untoward medical occurrence that at any dose may result 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.
Time frame: Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Number of Participants With SAEs (Inclusive Multisystem Inflammatory Syndrome in Children [MIS-C]) | 0 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Number of Participants With SAEs (Inclusive Multisystem Inflammatory Syndrome in Children [MIS-C]) | 0 Participants |
Primary
Adolescents: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 1
Number of participants with solicited local AEs at 7 days after vaccination 1 were reported. 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 participants in their e-diary for 7 days post vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Time frame: 7 Days After Vaccination 1 (Day 8)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 1 | 29 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 1 | 1 Participants |
Primary
Adolescents: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 1
Number of participants with solicited systemic AEs at 7 days after vaccination 1 were reported. 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 1 (Day of vaccination1 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius).
Time frame: 7 Days After Vaccination 1 (Day 8)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 1 | 28 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 1 | 3 Participants |
Primary
Adolescents: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.
Time frame: 28 Days After Vaccination 1 (Day 29)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 12 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 2 Participants |
Primary
Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2
Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported.
Time frame: 28 days after Vaccination 2 (Day 85)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2 | 1742 ELISA unit per milliliter (EU/mL) | 95% Confidence Interval 1400 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2 | 1563 ELISA unit per milliliter (EU/mL) | 95% Confidence Interval 1273 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2 | 1130 ELISA unit per milliliter (EU/mL) | 95% Confidence Interval 802 |
Primary
Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2
Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported.
Time frame: 28 days after Vaccination 2 (Day 85)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2 | 455 Titer | 95% Confidence Interval 321 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2 | 490 Titer | 95% Confidence Interval 376 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2 | 364 Titer | 95% Confidence Interval 239 |
Primary
Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Time frame: 28 days after Vaccination 2 (Day 85)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2 | 100.0 Percentage of participants | 95% Confidence Interval 94.7 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2 | 100.0 Percentage of participants | 95% Confidence Interval 94.6 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2 | 96.7 Percentage of participants | 95% Confidence Interval 88.5 |
Primary
Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was less than or equal to the lower limit of quantification (\<=LLOQ) and the post-baseline sample was greater than (\>) LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (greater than or equal to \[\>=\] 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were 50 percent (%) inhibitory concentration (IC50) of 58 and 12,800 international unit per milliliter (IU/mL) respectively.
Time frame: 28 days after Vaccination 2 (Day 85)
Population: Per protocol immunogenicity (PPI) set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (positive PCR test or N-serology) after screening were excluded from analysis. N(Overall number of participants analyzed) signifies participants evaluated for this outcome measure(OM).
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2 | 96.8 Percentage of participants | 95% Confidence Interval 83.3 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2 | 100.0 Percentage of participants | 95% Confidence Interval 90.3 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2 | 88.9 Percentage of participants | 95% Confidence Interval 73.9 |
Primary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: 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 (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Time frame: Up to 1.5 years
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
Primary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Up to 1.5 years
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs) | 7 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1
Number of participants with solicited local AEs at 7 days after vaccination 1 were reported. 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 participants in their e-diary for 7 days after vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Time frame: 7 days after Vaccination 1 (Day 8)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 was reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1 | 27 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1 | 24 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1 | 39 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1 | 42 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1 | 21 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1 | 2 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1 | 75 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1 | 7 Participants |
Primary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2
Number of participants with solicited local AEs at 7 days after vaccination 2 were reported. 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 participants in their e-diary for 7 days post vaccination 2 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Time frame: 7 days after Vaccination 2 (Day 64 for Groups 1-6; Day 92 for Groups 9 and 10)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2 | 33 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2 | 29 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2 | 5 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2 | 4 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2 | 20 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2 | 2 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2 | 63 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2 | 3 Participants |
Primary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1
Number of participants with solicited systemic AEs at 7 days after vaccination 1 were reported. 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius).
Time frame: 7 days after Vaccination 1 (Day 8)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 | 35 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 | 31 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 | 56 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 | 50 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 | 32 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 | 10 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 | 84 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 | 18 Participants |
Primary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2
Number of participants with solicited systemic AEs at 7 days after vaccination 2 were reported. 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 2 (Day of vaccination 2 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius).
Time frame: 7 days after Vaccination 2 (Day 64 for Group 1-6; Day 92 for Group 9 and 10)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2 | 32 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2 | 25 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2 | 24 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2 | 20 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2 | 26 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2 | 6 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2 | 81 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2 | 14 Participants |
Primary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.
Time frame: 28 days after Vaccination 1 (Day 29)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 25 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 15 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 33 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 30 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 8 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 5 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 39 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 | 9 Participants |
Primary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.
Time frame: 28 days After Vaccination 2 (Day 85 for Groups 1-6; Day 113 for Groups 9 and 10)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2 | 17 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2 | 15 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2 | 16 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2 | 22 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2 | 10 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2 | 4 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2 | 34 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2 | 9 Participants |
Primary
Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1
Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 1 were reported. The LLOQ was 50.3 IU/mL.
Time frame: 28 days after Vaccination 1 (Day 29)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1 | 505 EU/mL |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1 | 360 EU/mL |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1 | NA EU/mL |
Primary
Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1
Antibody GMTs as measured by VNA at 28 days after vaccination 1 were reported. LLOQ was 58 IU/mL.
Time frame: 28 days after Vaccination 1 (Day 29)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 | 263 Titer |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 | 253 Titer |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 | NA Titer |
Primary
Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Time frame: 28 days after Vaccination 1 (Day 29)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1 | 98.5 Percentage of participants | 95% Confidence Interval 91.7 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1 | 95.4 Percentage of participants | 95% Confidence Interval 87.1 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1 | 0.0 Percentage of participants | 95% Confidence Interval 0 |
Primary
Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers at 28 Days After Vaccination 1
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Time frame: 28 days after Vaccination 1 (Day 29)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers at 28 Days After Vaccination 1 | 97.3 Percentage of participants | 95% Confidence Interval 85.8 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers at 28 Days After Vaccination 1 | 100.0 Percentage of participants | 95% Confidence Interval 89.7 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers at 28 Days After Vaccination 1 | 0.0 Percentage of participants | 95% Confidence Interval 0 |
Primary
Adults of Groups 9 and 10: Antibody GMCs as Measured by S-ELISA at 28 Days After Vaccination 2
Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported. The LLOQ was 50.3 IU/mL.
Time frame: 28 Days after Vaccination 2 (Day 113)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Antibody GMCs as Measured by S-ELISA at 28 Days After Vaccination 2 | 2391 EU/mL |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Antibody GMCs as Measured by S-ELISA at 28 Days After Vaccination 2 | NA EU/mL |
Primary
Adults of Groups 9 and 10: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 2
Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported. The LLOQ was 58 IU/mL.
Time frame: 28 days after Vaccination 2 (Day 113)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 2 | 901 Titer |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 2 | NA Titer |
Primary
Adults of Groups 9 and 10: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 2
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Time frame: 28 days after Vaccination 2 ( Day 113)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 2 | 100.0 Percentage of participants | 95% Confidence Interval 90 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 2 | 15.4 Percentage of participants | 95% Confidence Interval 1.9 |
Primary
Adults of Groups 9 and 10: Percentage of Participant With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 2
Percentage of participant with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Time frame: 28 days after Vaccination 2 (Day 113)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Percentage of Participant With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 2 | 100.0 Percentage of participants | 95% Confidence Interval 92.3 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Percentage of Participant With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 2 | 4.3 Percentage of participants | 95% Confidence Interval 0.1 |
Secondary
Adolescents: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1
Antibody GMCs as measured by S-ELISA 28 days after vaccination was reported. LLOQ was 58 IU/mL
Time frame: 28 days After Vaccination 1 (Day 29)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1 | 682 EU/mL |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1 | NA EU/mL |
Secondary
Adolescents: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1
Antibody GMTs as measured by VNA at 28 days after vaccination 1 (Day 29) were reported. LLOQ was 58 IU/mL
Time frame: 28 days After Vaccination 1 (Day 29)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 | 305 Titer |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 | NA Titer |
Secondary
Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA
Binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins as measured by ELISA was reported. LLOQ was 58 IU/mL.
Time frame: Days 57, 85, 169
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Number analyzed signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA | Day 57 | 770 Titer |
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA | Day 85 | 773 Titer |
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA | Day 169 | 796 Titer |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA | Day 57 | NA Titer |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA | Day 85 | NA Titer |
Secondary
Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA
Neutralizing antibody titers to the Wild-type SARS-CoV-2 virus expressing S protein measured by VNA was reported. LLOQ was 58 IU/mL.
Time frame: Days 57, 85 and 169
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Number analyzed signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA | Day 57 | 323 Titer |
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA | Day 85 | 306 Titer |
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA | Day 169 | 342 Titer |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA | Day 57 | NA Titer |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA | Day 85 | NA Titer |
Secondary
Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 28 Days After Vaccination 1 (Day 29)
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Time frame: 28 Days After Vaccination 1 (Day 29)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 28 Days After Vaccination 1 (Day 29) | 100.0 Percentage of participants | 95% Confidence Interval 86.8 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 28 Days After Vaccination 1 (Day 29) | 0.0 Percentage of participants | 95% Confidence Interval 0 |
Secondary
Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 (Day 29)
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Time frame: 28 Days After Vaccination 1 (Day 29)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 (Day 29) | 100.0 Percentage of participants | 95% Confidence Interval 87.2 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 (Day 29) | 0.0 Percentage of participants | 95% Confidence Interval 0 |
Secondary
Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA
Percentage of participants with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported.
Time frame: Days 225 and 421
Population: PPI set was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 225 | 100.0 Percentage of participants |
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 421 | 100.0 Percentage of participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 225 | 0.0 Percentage of participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 421 | 0.0 Percentage of participants |
Secondary
Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins
Percentage of participants with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported.
Time frame: Days 197 and 393
Population: PPI set was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 197 | 100.0 Percentage of participants |
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 393 | 100.0 Percentage of participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 393 | 100.0 Percentage of participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 197 | 100.0 Percentage of participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 393 | 85.7 Percentage of participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 197 | 98.2 Percentage of participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 393 | 92.2 Percentage of participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 197 | 100.0 Percentage of participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 393 | 98.0 Percentage of participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 197 | 98.2 Percentage of participants |
| Group 10: Placebo, Placebo, Placebo | Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 197 | 0.0 Percentage of participants |
Secondary
Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA
Percentage of participants with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported.
Time frame: Days 197 and 393
Population: PPI set was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 197 | 100.0 Percentage of participants |
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 393 | 93.1 Percentage of participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 393 | 95.2 Percentage of participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 197 | 100.0 Percentage of participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 393 | 84.2 Percentage of participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 197 | 96.6 Percentage of participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 393 | 80.0 Percentage of participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 197 | 96.8 Percentage of participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 393 | 92.0 Percentage of participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 197 | 80.8 Percentage of participants |
| Group 10: Placebo, Placebo, Placebo | Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA | Day 197 | 0.0 Percentage of participants |
Secondary
Adults of Group 7: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation
Antibody GMCs as measured by S-ELISA 7 days after antigen presentation were reported.
Time frame: Day 148
Population: Modified PPI set included participants who received vaccination 2 within the window (54-64 days).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Group 7: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation | 1141 EU/mL |
Secondary
Adults of Group 7: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL. respectively.
Time frame: Day 148
Population: Modified PPI set included participants who received vaccination 2 within the window (54-64 days).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Group 7: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 96.8 Percentage of participants |
Secondary
Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation
Antibody GMCs as measured by S-ELISA 7 days after antigen presentation were reported.
Time frame: 7 Days after Antigen Presentation (Day 176 for Groups 1-5; Day 204 for Group 9)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation | 1146 EU/mL | 95% Confidence Interval 904 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation | 1179 EU/mL | 95% Confidence Interval 933 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation | 1038 EU/mL | 95% Confidence Interval 730 |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation | 1024 EU/mL | 95% Confidence Interval 721 |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation | 1262 EU/mL | 95% Confidence Interval 937 |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation | 1963 EU/mL | 95% Confidence Interval 1514 |
Secondary
Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Time frame: 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 100.0 Percentage of participants | 95% Confidence Interval 94.2 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 100.0 Percentage of participants | 95% Confidence Interval 94.2 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 96.5 Percentage of participants | 95% Confidence Interval 87.9 |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 100.0 Percentage of participants | 95% Confidence Interval 93.7 |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 91.2 Percentage of participants | 95% Confidence Interval 80.7 |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 100.0 Percentage of participants | 95% Confidence Interval 91.8 |
Secondary
Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation
Antibody GMTs as measured by VNA at 7 days after antigen presentation were reported.
Time frame: 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Due to change in planned analysis, data was not collected and analyzed for Group 7 in this outcome measure. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation | 318 Titer | 95% Confidence Interval 207 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation | 393 Titer | 95% Confidence Interval 272 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation | 279 Titer | 95% Confidence Interval 171 |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation | 275 Titer | 95% Confidence Interval 182 |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation | 525 Titer | 95% Confidence Interval 339 |
| Groups 1 and 7 Combined | Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation | 616 Titer | 95% Confidence Interval 462 |
Secondary
Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL, respectively.
Time frame: 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Due to change in planned analysis, data was not collected and analyzed for Group 7 in this outcome measure. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation | 92.0 Percentage of participants | 95% Confidence Interval 74 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation | 97.0 Percentage of participants | 95% Confidence Interval 84.2 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation | 83.9 Percentage of participants | 95% Confidence Interval 66.3 |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation | 84.8 Percentage of participants | 95% Confidence Interval 68.1 |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation | 96.3 Percentage of participants | 95% Confidence Interval 81 |
| Groups 1 and 7 Combined | Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation | 100.0 Percentage of participants | 95% Confidence Interval 89.1 |
Secondary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation
AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Time frame: After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation | 0 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation | 0 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation | 0 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation | 1 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation | 0 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation | 0 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation | 0 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation | 0 Participants |
Secondary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation
SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time frame: After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation | 0 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation | 0 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation | 1 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation | 0 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation | 0 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation | 0 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation | 1 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation | 0 Participants |
Secondary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation
Number of participants with solicited local AEs at 7 days after antigen presentation were reported. 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 participants in their e-diary for 7 days after antigen presentation (day of antigen presentation and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Time frame: 7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation | 28 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation | 29 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation | 31 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation | 35 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation | 16 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation | 2 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation | 50 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation | 1 Participants |
Secondary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation
Number of participants with solicited systemic AEs at 7 days after antigen presentation were reported. 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days after antigen presentation (Day of antigen presentation and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius).
Time frame: 7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation | 30 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation | 24 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation | 23 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation | 28 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation | 15 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation | 4 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation | 51 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation | 10 Participants |
Secondary
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participants diary.
Time frame: 28 Days After Antigen Presentation (Day 197 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 225 for Group 9 and 10)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation | 10 Participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation | 7 Participants |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation | 6 Participants |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation | 12 Participants |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation | 6 Participants |
| Group 10: Placebo, Placebo, Placebo | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation | 4 Participants |
| Groups 1 and 7 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation | 15 Participants |
| Group 6 and 8 Combined | Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation | 4 Participants |
Secondary
Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins
Percentage of participants with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported.
Time frame: Days 225 and 421
Population: PPI set was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 225 | 100.0 Percentage of participants |
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 421 | 97.4 Percentage of participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 225 | 0.0 Percentage of participants |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins | Day 421 | 0.0 Percentage of participants |
Secondary
Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was \<=LLOQ and the post-baseline sample was \>LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Time frame: 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)
Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 100.0 Percentage of participants | 95% Confidence Interval 94.2 |
| Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 100.0 Percentage of participants | 95% Confidence Interval 94.2 |
| Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 96.5 Percentage of participants | 95% Confidence Interval 87.9 |
| Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp | Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 100.0 Percentage of participants | 95% Confidence Interval 93.7 |
| Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp | Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 91.2 Percentage of participants | 95% Confidence Interval 80.7 |
| Group 10: Placebo, Placebo, Placebo | Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation | 100.0 Percentage of participants | 95% Confidence Interval 91.8 |