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| ID | Type | Description | Link |
|---|---|---|---|
| VAC31518COV2001 | Other Identifier | Janssen Vaccines & Prevention B.V. | |
| 2020-002584-63 | EudraCT Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Groups 1-6 | Experimental | Participants will receive a 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 57 at different dose levels (Groups 1-3), or a single-dose Ad26.COV2.S vaccination regimen at different dose levels (Groups 4-5), or placebo (Group 6). At unblinded phase, participants in Group 6 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Groups 1-5) or placebo (Group 6). |
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| Groups 7-8 | Experimental | Participants will receive 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 29 at fixed dose level (Groups 7) or placebo (Groups 8). At unblinded phase, participants in Group 8 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Group 7) or placebo (Group 8). |
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| Groups 9-10 | Experimental | Participants will receive 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 85 at fixed dose level (Group 9) or placebo (Group 10). At unblinded phase, participants in Group 10 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Group 9) or placebo (Group 10). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.COV2.S | Biological | All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days after Vaccination 2 (Day 85) |
| 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. | 28 days after Vaccination 2 (Day 85) |
| 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. | 28 days after Vaccination 2 (Day 85) |
| Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
For Adults
For Adolescents:
Exclusion Criteria:
For Adults
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | 10117 | Germany | |||
| CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38705804 | Derived | Cardenas V, Le Gars M, Truyers C, Ruiz-Guinazu J, Struyf F, Colfer A, Bonten M, Borobia A, Reisinger EC, Kamerling IMC, Douoguih M, Sadoff J. Safety and immunogenicity of Ad26.COV2.S in adults: A randomised, double-blind, placebo-controlled Phase 2a dose-finding study. Vaccine. 2024 Jun 11;42(16):3536-3546. doi: 10.1016/j.vaccine.2024.04.059. Epub 2024 May 4. | |
| 35667914 |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2021 | Mar 9, 2023 |
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| Groups A-C | Experimental | Participants will receive a single dose Ad26.COV2.S vaccination regimen at Day 1 at fixed dose level (Groups A and B) or placebo (Group C). At approximately 6 months of study participation (unblinded phase), participants in Group C initially receiving placebo will receive Ad26.COV2.S vaccine at a single dose level, at a 56-day interval. |
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| Placebo | Other | Adult participants in Groups 4, 5, 6, 8, and 10, and adolescent participants in Group C will receive at least one injection of placebo. |
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Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported. |
| 28 days after Vaccination 2 (Day 85) |
| 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. | 28 days after Vaccination 1 (Day 29) |
| 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. | 28 days after Vaccination 1 (Day 29) |
| 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. | 28 days after Vaccination 1 (Day 29) |
| 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. | 28 days after Vaccination 1 (Day 29) |
| 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. | 28 days after Vaccination 2 ( Day 113) |
| 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. | 28 days after Vaccination 2 (Day 113) |
| 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. | 28 days after Vaccination 2 (Day 113) |
| 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. | 28 Days after Vaccination 2 (Day 113) |
| 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. | 7 days after Vaccination 1 (Day 8) |
| 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). | 7 days after Vaccination 1 (Day 8) |
| 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. | 7 days after Vaccination 2 (Day 64 for Groups 1-6; Day 92 for Groups 9 and 10) |
| 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). | 7 days after Vaccination 2 (Day 64 for Group 1-6; Day 92 for Group 9 and 10) |
| 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. | 28 days after Vaccination 1 (Day 29) |
| 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. | 28 days After Vaccination 2 (Day 85 for Groups 1-6; Day 113 for Groups 9 and 10) |
| 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. | Up to 1.5 years |
| 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. | Up to 1.5 years |
| 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. | 7 Days After Vaccination 1 (Day 8) |
| 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). | 7 Days After Vaccination 1 (Day 8) |
| 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. | 28 Days After Vaccination 1 (Day 29) |
| 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. | Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years) |
| 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. | Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years) |
| 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9) |
| 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. | 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9) |
| 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. | 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9) |
| 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. | Day 148 |
| 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. | 7 Days after Antigen Presentation (Day 176 for Groups 1-5; Day 204 for Group 9) |
| 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. | Day 148 |
| 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. | 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) |
| 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). | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | Days 197 and 393 |
| 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. | Days 225 and 421 |
| 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. | Days 197 and 393 |
| 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. | Days 225 and 421 |
| 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. | 28 Days After Vaccination 1 (Day 29) |
| 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. | 28 Days After Vaccination 1 (Day 29) |
| 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 | 28 days After Vaccination 1 (Day 29) |
| 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 | 28 days After Vaccination 1 (Day 29) |
| 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. | Days 57, 85 and 169 |
| 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. | Days 57, 85, 169 |
| 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. | 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9) |
| Hamburg |
| 20251 |
| Germany |
| Universitaetsmedizin Rostock | Rostock | 18057 | Germany |
| PRA Health Sciences | Groningen | NZ 9728 | Netherlands |
| Centre for Human Drug Research | Leiden | 2333 CL | Netherlands |
| UMCU | Utrecht | 3584 CX | Netherlands |
| Hosp. Univ. de La Princesa | Madrid | 28006 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| Alder Hey Hospital | Liverpool | L12 2AP | United Kingdom |
| St George's, University of London | London | SW17 0RE | United Kingdom |
| Royal Manchester Children's Hospital | Manchester | M13 9WL | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | SO166YD | United Kingdom |
| Sadoff J, Le Gars M, Brandenburg B, Cardenas V, Shukarev G, Vaissiere N, Heerwegh D, Truyers C, de Groot AM, Jongeneelen M, Kaszas K, Tolboom J, Scheper G, Hendriks J, Ruiz-Guinazu J, Struyf F, Van Hoof J, Douoguih M, Schuitemaker H. Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials. Vaccine. 2022 Jul 30;40(32):4403-4411. doi: 10.1016/j.vaccine.2022.05.047. Epub 2022 Jun 3. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| FG009 | 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. |
| FG010 | 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. |
| FG011 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | 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. |
| BG009 | 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. |
| BG010 | 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. |
| BG011 | 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. |
| BG012 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| 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. | 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). | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 days after Vaccination 2 (Day 85) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 days after Vaccination 2 (Day 85) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 28 days after Vaccination 2 (Day 85) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ELISA unit per milliliter (EU/mL) | 28 days after Vaccination 2 (Day 85) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 days after Vaccination 1 (Day 29) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 days after Vaccination 1 (Day 29) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 28 days after Vaccination 1 (Day 29) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 28 days after Vaccination 1 (Day 29) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 days after Vaccination 2 ( Day 113) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 days after Vaccination 2 (Day 113) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 28 days after Vaccination 2 (Day 113) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 28 Days after Vaccination 2 (Day 113) |
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| 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. | 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. | Posted | Count of Participants | Participants | 7 days after Vaccination 1 (Day 8) |
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| 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). | 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. | Posted | Count of Participants | Participants | 7 days after Vaccination 1 (Day 8) |
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| 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. | 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. | Posted | Count of Participants | Participants | 7 days after Vaccination 2 (Day 64 for Groups 1-6; Day 92 for Groups 9 and 10) |
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| 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). | 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. | Posted | Count of Participants | Participants | 7 days after Vaccination 2 (Day 64 for Group 1-6; Day 92 for Group 9 and 10) |
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| 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. | 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. | Posted | Count of Participants | Participants | 28 days after Vaccination 1 (Day 29) |
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| 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. | 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. | Posted | Count of Participants | Participants | 28 days After Vaccination 2 (Day 85 for Groups 1-6; Day 113 for Groups 9 and 10) |
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| 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. | 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. | Posted | Count of Participants | Participants | Up to 1.5 years |
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| 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. | 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. | Posted | Count of Participants | Participants | Up to 1.5 years |
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| 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. | FAS included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | 7 Days After Vaccination 1 (Day 8) |
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| 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). | FAS included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | 7 Days After Vaccination 1 (Day 8) |
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| 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. | FAS included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | 28 Days After Vaccination 1 (Day 29) |
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| 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. | FAS included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years) |
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| 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. | FAS included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9) |
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| 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. | Modified PPI set included participants who received vaccination 2 within the window (54-64 days). | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 148 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 7 Days after Antigen Presentation (Day 176 for Groups 1-5; Day 204 for Group 9) |
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| 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. | Modified PPI set included participants who received vaccination 2 within the window (54-64 days). | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Day 148 |
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| 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. | 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. | Posted | Count of Participants | Participants | 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) |
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| 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). | 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. | Posted | Count of Participants | Participants | 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) |
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| 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. | 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. | Posted | Count of Participants | Participants | 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) |
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| 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. | 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. | Posted | Count of Participants | Participants | 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) |
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| 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. | 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. | Posted | Count of Participants | Participants | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Days 197 and 393 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Days 225 and 421 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Days 197 and 393 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Days 225 and 421 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 Days After Vaccination 1 (Day 29) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 Days After Vaccination 1 (Day 29) |
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| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 28 days After Vaccination 1 (Day 29) |
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| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 28 days After Vaccination 1 (Day 29) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Days 57, 85 and 169 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Days 57, 85, 169 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9) |
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Up to 1.5 years
FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 141 | 7 | 141 | 35 | 141 |
| EG001 | 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. | 1 | 81 | 1 | 81 | 24 | 81 |
| EG002 | 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. | 0 | 75 | 1 | 75 | 20 | 75 |
| EG003 | 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. | 0 | 74 | 1 | 74 | 20 | 74 |
| EG004 | 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. | 0 | 81 | 2 | 81 | 33 | 81 |
| EG005 | 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. | 0 | 52 | 0 | 52 | 11 | 52 |
| EG006 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG007 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG008 | 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. | 0 | 53 | 1 | 53 | 16 | 53 |
| EG009 | 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. | 0 | 25 | 0 | 25 | 9 | 25 |
| EG010 | 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. | 0 | 30 | 0 | 30 | 11 | 30 |
| EG011 | 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. | 0 | 3 | 0 | 3 | 2 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hepatic Cyst | Hepatobiliary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Systemic Candida | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Adenocarcinoma of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cerebrospinal Fluid Leakage | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pain | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Premenstrual Pain | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SENIOR ADVISOR CLINICAL DEVELOPMENT | Janssen Vaccines & Prevention B.V. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 7, 2022 | Mar 9, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 27, 2020 | Apr 28, 2023 | ICF_003.pdf |
Not provided
| ID | Term |
|---|---|
| D000090984 | Ad26COVS1 |
| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Adolescents (16-17 years) |
|
| Adults (18-64 years) |
|
| From 65 to 84 years |
|
| 85 years and over |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
|
|
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Groups 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult subjects received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
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| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
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| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | Group 1 and 7 Combined | Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination. |
| OG007 | Group 6 and 8 Combined | Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and 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. |
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| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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| 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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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.
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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