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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005720-11 | EudraCT Number | ||
| VAC31518COV3006 | Other Identifier | Janssen Vaccines & Prevention B.V. |
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The primary purpose of this study is to assess the safety, reactogenicity, and humoral immune response of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents.
Available safety, immunogenicity and efficacy data from the Ad26.COV2.S vaccine development program supports initiating evaluation of Ad26.COV2.S in the pediatric population. Ad26.COV2.S will be evaluated in the pediatric population through a dose-confirmation approach. Ad26.COV2.S (also known as Ad26COVS1, VAC31518, JNJ-78436735) is a monovalent vaccine composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus(-2) (SARS-CoV-2) spike (S) protein, stabilized in its prefusion conformation. The study duration from screening until the last follow-up visit will be, excluding the 28-day screening phase, 8 months (Groups 4-6) to 12 months (Groups 1-3), consisting of 12-month study duration comprising a study period (6-months) including vaccination with a 1 active dose and a placebo vaccination (56-day interval), followed by a booster vaccination at 6 months and follow-up (safety and immunogenicity) until at least 6 months after booster vaccination (Groups 1-3) and 8 month study duration comprising 2 active doses (56-day interval) and follow-up (safety and immunogenicity) until at least 6 months after second vaccination (Groups 4-6). Assessments like immunogenicity (such as humoral and cellular immune responses), safety and reactogenicity (such as adverse events [AEs] monitoring) will be performed in this study. Other safety assessments include vital signs measurements (heart rate, supine systolic and diastolic blood pressure, respiratory rate, and body temperature) and physical examinations. The overall study duration from enrolment of the first participant until study completion is expected to be up to 1 year 11 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Ad26.COV2.S Dose Level 1 (Lower Volume): 1-Dose Regimen | Experimental | Participants will receive 1-dose of Ad26.COV2.S at dose level 1 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184. |
|
| Group 2: Ad26.COV2.S Dose Level 2: 1-Dose Regimen | Experimental | Participants will receive 1-dose of Ad26.COV2.S at dose level 2 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184. |
|
| Group 3: Ad26.COV2.S Dose Level 3: 1-Dose Regimen | Experimental | Participants will receive 1-dose of Ad26.COV2.S at dose level 3 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184. |
|
| Group 4: Ad26.COV2.S Dose Level 1: 2-Dose Regimen | Experimental | Participants will receive 2-dose of Ad26.COV2.S at dose level 1 on Day 1 and 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.COV2.S | Biological | Ad26.COV2.S will be administered as intramuscular (IM) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site. | 7 days post-dose 1 on Day 1 (Day 8) |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, swelling at the vaccination site. | 7 days post-dose 2 on Day 57 (Day 64) |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia and pyrexia. |
| Measure | Description | Time Frame |
|---|---|---|
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or Individual SARS-CoV-2 S Proteins as Assessed by ELISA | Serological response to vaccination measured by binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 S proteins as assessed by ELISA were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| CIPREC | Buenos Aires | C1119ACN | Argentina | |||
| Hospital de Ninos de Cordoba |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39868766 | Derived | Tica J, Rezelj VV, Baron B, van Paassen V, Zaidman J, Fairlie L, Scheper G, Le Gars M, Struyf F, Douoguih M, Ruiz-Guinazu J; COV3006 study group; COV3006 Study Group Collaborators. Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial. Hum Vaccin Immunother. 2025 Dec;21(1):2450120. doi: 10.1080/21645515.2025.2450120. Epub 2025 Jan 27. |
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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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Of the 304 randomized participants, 3 participants were randomized to an arm that was closed prior to vaccination due to ethical reasons. One participant was excluded from the analysis due to lack of a valid informed consent form and is not presented in the below table.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Participants received a single dose of Ad26.COV.S 2.5*10^10 virus particle (vp) as intramuscular (IM) injection on Day 1 and placebo matching to Ad26.COV.S 2.5*10^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| 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 | Aug 15, 2022 | Mar 8, 2024 |
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| Group 5: Ad26.COV2.S Dose Level 2: 2-Dose Regimen | Experimental | Participants will receive 2-doses of Ad26.COV2.S at dose level 2 on Day 1 and Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
| Group 6: Ad26.COV2.S Dose Level 3: 2-Dose Regimen | Experimental | Participants will receive 2-doses of Ad26.COV2.S at dose level 3 on Day 1 and Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| 7 days post-dose 1 on Day 1 (Day 8) |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia and pyrexia. | 7 days post-dose 2 on Day 57 (Day 64) |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. | 28 days post-dose 1 on Day 1 (Day 29) |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2 | Description: An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. | 28 days post-dose 2 on Day 57 (Day 85) |
| Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1 | MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. | From the first vaccination (Day 1) until 6 months post-dose 1 on Day 1 (Up to Day 184) |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2 | MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. | From the first vaccination (Day 1) until 6 months post-dose 2 on Day 57 (Up to Day 240) |
| Groups 1, 2, and 3: Number of Participants With MAAEs Leading to Discontinuation | Number of participants with MAAEs leading to discontinuation were reported. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) |
| Groups 4, 5 and 6: Number of Participants With MAAEs Leading to Discontinuation | Number of participants with MAAEs leading to discontinuation were reported. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. | From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57) |
| Groups 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | SAE were defined as any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) |
| Groups 4, 5 and 6: Number of Participants With Serious Adverse Events (SAEs) | SAE were defined as any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57) |
| Groups 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C]) | Number of participants with AESI (including MIS-C) were reported. Thrombotic events (suspected deep vessel venous or arterial thrombotic events); Thrombocytopenia (platelet count below 150,000/μL) and MIS-C (a subject <21 years with fever, evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement [cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological]; & No alternative diagnoses; & Positive for ositive for current or recent (SARS-CoV-2) coronavirus disease 2019 [COVID-19] infection by Real-time reverse transcriptase-polymerase chain reaction [RT-PCR], serology, or antigen test; Or COVID-19 exposure within the 4 weeks prior to the onset of symptoms) were considered AESIs in this study. | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) |
| Groups 4, 5 and 6: Number of Participants With AESI (Including MIS-C) | Number of participants with AESI (including MIS-C) were reported. Thrombotic events: suspected deep vessel venous or arterial thrombotic events and Thrombocytopenia, defined as platelet count below 150,000/μL and MIS-C were considered as AESIs in this study. MIS-C, defined as: An individual aged <21 years presenting with fever, laboratory evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic,or neurological); AND No alternative plausible diagnoses; AND Positive for current or recent SARS-CoV-2 (COVID-19) infection by RT-PCR, serology, or antigen test; or COVID-19 exposure within the 4 weeks prior to the onset of symptoms. | From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57) |
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Spike-enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days Post-dose 1 | Serological response to vaccination measured by S-ELISA (ELISA Unit/milliliter (EU/mL)) at 28 days post-dose 1 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of less than or equal to the lower limit of quantification (<=LLOQ) and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. | 28 days post-dose 1 on Day 1 (Day 29) |
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2 | Serological response to vaccination measured by S-ELISA (EU/mL) at 14 days post-dose 2 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. | 14 days post-dose 2 on Day 57 (Day 71) |
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 | Serological response to vaccination measured by VNA titers at 28 days post-dose 1 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as 50 percent (%) inhibitory concentration (IC50) units. | 28 days post-dose 1 on Day 1 (Day 29) |
| Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 | Serological response to vaccination measured by VNA titers 14 days post-dose 2 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as IC50 units. | 14 days post-dose 2 on Day 57 (Day 71) |
| Groups 1-3: Days 1, 29, 57, 71, 184, 198, and 366; Groups 4-6: Days 1, 29, 57, 71 and 240 |
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Serological response to vaccination measured by neutralizing antibody titers to SARS-CoV-2 (VNA) were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as IC50 units. | Groups 1-3: Days 1, 29, 57, 71, 184, 198 and 366; Groups 4-6: Days 1, 29, 57, 71 and 240 |
| Groups 1, 2 and 3: Number of Participants With Solicited Local AEs for 7 Days Post-booster Vaccination | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol. | From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184) |
| Groups 1, 2 and 3: Number of Participants With Solicited Systemic AEs for 7 Days Post-booster Vaccination | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia and pyrexia. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol. | From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184) |
| Groups 1, 2 and 3: Number of Participants With Unsolicited AEs for 28 Days Post-booster Vaccination | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol. | From first vaccination on Day 1 up to Day 212 (28 days after booster Vaccination on Day 184) |
| Groups 1, 2 and 3: Number of Participants With MAAEs Until 6 Months Post-booster Vaccination | MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol. | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) |
| Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Serological response to post-booster vaccination measured by binding (S-ELISA) antibody titers were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol. | Days 184, 198 and 366 |
| Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Serological response to post-booster vaccination measured by neutralizing (VNA) antibody titers were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as IC50 units. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol. | Days 184, 198 and 366 |
| Córdoba |
| 5000 |
| Argentina |
| Hospital del Niño Jesús | San Miguel de Tucumán | 4000 | Argentina |
| Universidade Federal De Minas Gerais - Hospital das ClÃnicas | Belo Horizonte | 30130-100 | Brazil |
| Santa Casa de Misericordia de Belo Horizonte | Belo Horizonte | 30150-221 | Brazil |
| Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP | Ribeirão Preto | 14051-140 | Brazil |
| CPQuali Pesquisa Clinica LTDA ME | São Paulo | 01228-000 | Brazil |
| Sri ramchandra Medical College & Research Institute | Chennai | 600116 | India |
| JSS Hospital | Mysore | 570004 | India |
| Supe Heart And Diabetes Hospital and Research Center | Nashik | 0422002 | India |
| BAPS Pramukhswami Hospital | Surat | 395009 | India |
| CAIMED Investigacion en salud S.A de C.V. | Mexico City | 06760 | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez | Monterrey | 64460 | Mexico |
| Ndlovu Elandsdoorn Site | Dennilton | 0485 | South Africa |
| Shandukani Research Centre | Johannesburg | 2001 | South Africa |
| Setshaba Research Centre | Soshanguve | 152 | South Africa |
| Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital | Soweto | 1864 | South Africa |
| University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre | Westdene Johannesburg Gauteng | 2092 | South Africa |
| FG001 | Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| FG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| FG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received a single dose of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| FG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| FG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| Vaccinated |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline analysis population included all participants with at least one vaccine administration documented.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Participants received a single dose of Ad26.COV.S 2.5*10^10 virus particle (vp) as intramuscular (IM) injection on Day 1 and placebo matching to Ad26.COV.S 2.5*10^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| BG001 | Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| BG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| BG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received a single dose of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| BG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| BG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| BG006 | 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 | ||||||||||
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| 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 | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site. | Safety analyses set included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | 7 days post-dose 1 on Day 1 (Day 8) |
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| Primary | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, swelling at the vaccination site. | Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 7 days post-dose 2 on Day 57 (Day 64) |
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| Primary | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia and pyrexia. | Safety analyses set included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | 7 days post-dose 1 on Day 1 (Day 8) |
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| Primary | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia and pyrexia. | Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 7 days post-dose 2 on Day 57 (Day 64) |
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| Primary | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. | Safety analyses set included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | 28 days post-dose 1 on Day 1 (Day 29) |
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| Primary | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2 | Description: An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. | Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and "n" (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | 28 days post-dose 2 on Day 57 (Day 85) |
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| Primary | Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1 | MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. | Safety analyses set included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | From the first vaccination (Day 1) until 6 months post-dose 1 on Day 1 (Up to Day 184) |
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| Primary | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2 | MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. | Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From the first vaccination (Day 1) until 6 months post-dose 2 on Day 57 (Up to Day 240) |
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| Primary | Groups 1, 2, and 3: Number of Participants With MAAEs Leading to Discontinuation | Number of participants with MAAEs leading to discontinuation were reported. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. | Safety analyses set included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) |
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| Primary | Groups 4, 5 and 6: Number of Participants With MAAEs Leading to Discontinuation | Number of participants with MAAEs leading to discontinuation were reported. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. | Safety analyses set included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57) |
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| Primary | Groups 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | SAE were defined as any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | Safety analyses set included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) |
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| Primary | Groups 4, 5 and 6: Number of Participants With Serious Adverse Events (SAEs) | SAE were defined as any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | Safety analyses set included all participants with at least one vaccine administration documented. | Posted | Count of Participants | Participants | From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57) |
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| Primary | Groups 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C]) | Number of participants with AESI (including MIS-C) were reported. Thrombotic events (suspected deep vessel venous or arterial thrombotic events); Thrombocytopenia (platelet count below 150,000/μL) and MIS-C (a subject <21 years with fever, evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement [cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological]; & No alternative diagnoses; & Positive for ositive for current or recent (SARS-CoV-2) coronavirus disease 2019 [COVID-19] infection by Real-time reverse transcriptase-polymerase chain reaction [RT-PCR], serology, or antigen test; Or COVID-19 exposure within the 4 weeks prior to the onset of symptoms) were considered AESIs in this study. | Safety analyses set included all participants with at least one vaccine administration documented. 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) |
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| Primary | Groups 4, 5 and 6: Number of Participants With AESI (Including MIS-C) | Number of participants with AESI (including MIS-C) were reported. Thrombotic events: suspected deep vessel venous or arterial thrombotic events and Thrombocytopenia, defined as platelet count below 150,000/μL and MIS-C were considered as AESIs in this study. MIS-C, defined as: An individual aged <21 years presenting with fever, laboratory evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic,or neurological); AND No alternative plausible diagnoses; AND Positive for current or recent SARS-CoV-2 (COVID-19) infection by RT-PCR, serology, or antigen test; or COVID-19 exposure within the 4 weeks prior to the onset of symptoms. | Safety analyses set included all participants with at least one vaccine administration documented. 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57) |
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| Primary | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Spike-enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days Post-dose 1 | Serological response to vaccination measured by S-ELISA (ELISA Unit/milliliter (EU/mL)) at 28 days post-dose 1 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of less than or equal to the lower limit of quantification (<=LLOQ) and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. | The Per Protocol Immunogenicity (PPI) set included all randomized and vaccinated participants for whom immunogenicity data were available excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | ELISA Unit/milliliter (EU/mL) | 28 days post-dose 1 on Day 1 (Day 29) |
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| Primary | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2 | Serological response to vaccination measured by S-ELISA (EU/mL) at 14 days post-dose 2 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. | The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 14 days post-dose 2 on Day 57 (Day 71) |
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| Primary | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 | Serological response to vaccination measured by VNA titers at 28 days post-dose 1 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as 50 percent (%) inhibitory concentration (IC50) units. | The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" number of participants analyzed signifies the number of participants that were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 28 days post-dose 1 on Day 1 (Day 29) |
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| Primary | Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 | Serological response to vaccination measured by VNA titers 14 days post-dose 2 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as IC50 units. | The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" number of participants analyzed signifies the number of participants that were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 14 days post-dose 2 on Day 57 (Day 71) |
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| Secondary | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or Individual SARS-CoV-2 S Proteins as Assessed by ELISA | Serological response to vaccination measured by binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 S proteins as assessed by ELISA were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. | PPI set: all randomized and vaccinated participants with available immunogenicity data excluding data from participants with major protocol deviations expected to impact immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure, and "n"(number analyzed) signifies participants analyzed at specified timepoints (where "n=0", data were not planned to be analyzed at specified timepoint for specific arm). | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Groups 1-3: Days 1, 29, 57, 71, 184, 198, and 366; Groups 4-6: Days 1, 29, 57, 71 and 240 |
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| Secondary | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Serological response to vaccination measured by neutralizing antibody titers to SARS-CoV-2 (VNA) were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as IC50 units. | PPI set: all randomized and vaccinated participants with available immunogenicity data excluding data from participants with major protocol deviations expected to impact immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure, and "n"(number analyzed) signifies participants analyzed at specified timepoints (where "n=0", data were not planned to be analyzed at specified timepoint for specific arm). "NA"=\ | Posted | Geometric Mean | 95% Confidence Interval | Titers | Groups 1-3: Days 1, 29, 57, 71, 184, 198 and 366; Groups 4-6: Days 1, 29, 57, 71 and 240 |
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| Secondary | Groups 1, 2 and 3: Number of Participants With Solicited Local AEs for 7 Days Post-booster Vaccination | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol. | Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184) |
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| Secondary | Groups 1, 2 and 3: Number of Participants With Solicited Systemic AEs for 7 Days Post-booster Vaccination | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia and pyrexia. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol. | Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184) |
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| Secondary | Groups 1, 2 and 3: Number of Participants With Unsolicited AEs for 28 Days Post-booster Vaccination | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol. | Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From first vaccination on Day 1 up to Day 212 (28 days after booster Vaccination on Day 184) |
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| Secondary | Groups 1, 2 and 3: Number of Participants With MAAEs Until 6 Months Post-booster Vaccination | MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol. | Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) |
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| Secondary | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Serological response to post-booster vaccination measured by binding (S-ELISA) antibody titers were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol. | PPI set: All randomized and vaccinated participants with available immunogenicity data excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n" (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Days 184, 198 and 366 |
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| Secondary | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Serological response to post-booster vaccination measured by neutralizing (VNA) antibody titers were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as IC50 units. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol. | PPI set: All randomized and vaccinated participants with available immunogenicity data excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n" (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Days 184, 198 and 366 |
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Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
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 2.5*10^10 vp + Placebo | Participants received a single dose of Ad26.COV.S 2.5*10^10 virus particle (vp) as intramuscular (IM) injection on Day 1 and placebo matching to Ad26.COV.S 2.5*10^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. | 0 | 51 | 1 | 51 | 35 | 51 |
| EG001 | Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. | 1 | 50 | 1 | 50 | 32 | 50 |
| EG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. | 0 | 51 | 0 | 51 | 34 | 51 |
| EG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received a single dose of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. | 0 | 49 | 0 | 49 | 26 | 49 |
| EG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination | 0 | 49 | 1 | 49 | 29 | 49 |
| EG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. | 0 | 49 | 0 | 49 | 35 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
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| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
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| Vaginal Cyst Excision | Surgical and medical procedures | MedDRA 25.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Nausea(Solicited) | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Fatigue(Solicited) | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Pyrexia(Solicited) | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Vaccination Site Erythema(Solicited) | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Vaccination Site Pain(Solicited) | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Vaccination Site Swelling(Solicited) | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Myalgia(Solicited) | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Headache(Solicited) | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | 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 to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Franchise Leader | Janssen Vaccines & Prevention B.V. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2023 | Apr 26, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
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 (12-17 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 |
|
Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184.
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184.
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo |
Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184.
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
|
|
Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
|
|
Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| OG001 | Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
|
|
Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG002 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo |
Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184.
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184.
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| OG001 | Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| OG001 | Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG003 | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Participants received single doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
| OG004 | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Participants received single doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination |
| OG005 | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Participants received single doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. |
|
|
| OG001 |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo |
Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
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| OG001 | Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
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Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
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| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
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| OG001 |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo |
Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
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| OG001 | Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
| OG002 | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Participants received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184. |
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