Coronavirus Disease-2019 (COVID-19) Prevention
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAd26.COV2.S
Ad26.COV2.S will be administered as intramuscular (IM) injection.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant's age is 12 to 17 years of age at the time of first vaccination * Participant must be healthy, in the investigator's clinical judgement, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (COVID-19) * Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine * Participant and/or parent(s)/legal guardian(s) are available and willing to participate for the duration of the study visits and follow-up * Each participant or participant's parent(s)/legal guardian(s) must have access to a consistent means of contact either by telephone contact or email/computer
Exclusion criteria
* Participant has a history of malignancy, bone marrow transplant, or solid organ transplant within 5 years before screening * Participant has a known or suspected allergy, history of anaphylaxis, or other serious adverse reactions, related to vaccines or their excipients (including specifically the excipients of the study vaccine) * Use of systemic corticosteroids at an immunosuppressive dose (treatment duration more than 14 days for one course or recurrent use) within 6 months before administration of study vaccine and during the study * Participants with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the participant if he/she participates in the study * Any serious, chronic, or progressive disease (example: diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, acquired immunodeficiency syndrome \[AIDS\] infection, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 | 14 days post-dose 2 on Day 57 (Day 71) | 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. |
| Groups 4, 5 and 6: Number of Participants With MAAEs Leading to Discontinuation | From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57) | 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. |
| Groups 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) | 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. |
| Groups 4, 5 and 6: Number of Participants With Serious Adverse Events (SAEs) | From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57) | 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. |
| Groups 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C]) | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) | 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. |
| Groups 4, 5 and 6: Number of Participants With AESI (Including MIS-C) | From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57) | 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. |
| 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 | 28 days post-dose 1 on Day 1 (Day 29) | 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. |
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2 | 14 days post-dose 2 on Day 57 (Day 71) | 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. |
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 | 28 days post-dose 1 on Day 1 (Day 29) | 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. |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 | 7 days post-dose 1 on Day 1 (Day 8) | 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. |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2 | 7 days post-dose 2 on Day 57 (Day 64) | 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. |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1 | 7 days post-dose 1 on Day 1 (Day 8) | 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. |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2 | 7 days post-dose 2 on Day 57 (Day 64) | 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. |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1 | 28 days post-dose 1 on Day 1 (Day 29) | 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. |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2 | 28 days post-dose 2 on Day 57 (Day 85) | 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. |
| Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1 | From the first vaccination (Day 1) until 6 months post-dose 1 on Day 1 (Up to Day 184) | 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. |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2 | From the first vaccination (Day 1) until 6 months post-dose 2 on Day 57 (Up to Day 240) | 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. |
| Groups 1, 2, and 3: Number of Participants With MAAEs Leading to Discontinuation | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Groups 1-3: Days 1, 29, 57, 71, 184, 198 and 366; Groups 4-6: Days 1, 29, 57, 71 and 240 | 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, 2 and 3: Number of Participants With Solicited Local AEs for 7 Days Post-booster Vaccination | From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184) | 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. |
| Groups 1, 2 and 3: Number of Participants With Solicited Systemic AEs for 7 Days Post-booster Vaccination | From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184) | 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. |
| Groups 1, 2 and 3: Number of Participants With Unsolicited AEs for 28 Days Post-booster Vaccination | From first vaccination on Day 1 up to Day 212 (28 days after booster Vaccination on Day 184) | 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. |
| Groups 1, 2 and 3: Number of Participants With MAAEs Until 6 Months Post-booster Vaccination | From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184) | 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. |
| Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Days 184, 198 and 366 | 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. |
| Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Days 184, 198 and 366 | 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. |
| 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 | Groups 1-3: Days 1, 29, 57, 71, 184, 198, and 366; Groups 4-6: Days 1, 29, 57, 71 and 240 | 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. |
Countries
Argentina, Brazil, India, Mexico, South Africa
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| 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. | 50 |
| 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. | 51 |
| 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. | 49 |
| 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 | 49 |
| 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. | 49 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 | 1 | 1 |
| Overall Study | Other | 1 | 0 | 1 | 1 | 0 | 2 |
| Overall Study | Randomized not vaccinated | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 14.2 years STANDARD_DEVIATION 1.8 | 14.1 years STANDARD_DEVIATION 1.87 | 14 years STANDARD_DEVIATION 1.82 | 14.3 years STANDARD_DEVIATION 1.76 | 14.4 years STANDARD_DEVIATION 1.75 | 14.2 years STANDARD_DEVIATION 1.8 | 14.1 years STANDARD_DEVIATION 1.84 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 299 Participants | 51 Participants | 50 Participants | 51 Participants | 49 Participants | 49 Participants | 49 Participants |
| Age, Customized Adults (18-64 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Children (2-11 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized From 65 to 84 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 124 Participants | 22 Participants | 19 Participants | 24 Participants | 17 Participants | 16 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 172 Participants | 29 Participants | 30 Participants | 27 Participants | 32 Participants | 31 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants | 3 Participants | 4 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 108 Participants | 17 Participants | 19 Participants | 17 Participants | 22 Participants | 19 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 88 Participants | 17 Participants | 13 Participants | 16 Participants | 12 Participants | 14 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 82 Participants | 13 Participants | 13 Participants | 14 Participants | 12 Participants | 13 Participants | 17 Participants |
| Sex: Female, Male Female | 126 Participants | 22 Participants | 22 Participants | 21 Participants | 20 Participants | 21 Participants | 20 Participants |
| Sex: Female, Male Male | 173 Participants | 29 Participants | 28 Participants | 30 Participants | 29 Participants | 28 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 1 / 50 | 0 / 51 | 0 / 49 | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 35 / 51 | 32 / 50 | 34 / 51 | 26 / 49 | 29 / 49 | 35 / 49 |
| serious Total, serious adverse events | 1 / 51 | 1 / 50 | 0 / 51 | 0 / 49 | 1 / 49 | 0 / 49 |
Outcome results
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.
Time frame: From the first vaccination (Day 1) until 6 months post-dose 2 on Day 57 (Up to Day 240)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2 | 4 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2 | 6 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2 | 2 Participants |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2 | 2 Participants |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2 | 4 Participants |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2 | 5 Participants |
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.
Time frame: 7 days post-dose 1 on Day 1 (Day 8)
Population: Safety analyses set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 | 13 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 | 16 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 | 17 Participants |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 | 11 Participants |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 | 12 Participants |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 | 15 Participants |
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.
Time frame: 7 days post-dose 2 on Day 57 (Day 64)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2 | 8 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2 | 10 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2 | 3 Participants |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2 | 16 Participants |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2 | 9 Participants |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2 | 10 Participants |
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.
Time frame: 7 days post-dose 1 on Day 1 (Day 8)
Population: Safety analyses set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1 | 20 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1 | 13 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1 | 18 Participants |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1 | 14 Participants |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1 | 16 Participants |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1 | 16 Participants |
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.
Time frame: 7 days post-dose 2 on Day 57 (Day 64)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2 | 11 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2 | 10 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2 | 4 Participants |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2 | 14 Participants |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2 | 10 Participants |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2 | 11 Participants |
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.
Time frame: 28 days post-dose 1 on Day 1 (Day 29)
Population: Safety analyses set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1 | 9 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1 | 9 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1 | 5 Participants |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1 | 3 Participants |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1 | 8 Participants |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1 | 10 Participants |
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.
Time frame: 28 days post-dose 2 on Day 57 (Day 85)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2 | 7 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2 | 7 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2 | 8 Participants |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2 | 7 Participants |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2 | 7 Participants |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2 | 9 Participants |
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.
Time frame: 14 days post-dose 2 on Day 57 (Day 71)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2 | 4923 EU/mL | 95% Confidence Interval 3329 |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2 | 4679 EU/mL | 95% Confidence Interval 2748 |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2 | 4043 EU/mL | 95% Confidence Interval 2480 |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2 | 8958 EU/mL | 95% Confidence Interval 6333 |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2 | 8716 EU/mL | 95% Confidence Interval 6577 |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2 | 6522 EU/mL | 95% Confidence Interval 4461 |
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.
Time frame: 28 days post-dose 1 on Day 1 (Day 29)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | 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 | 6533 ELISA Unit/milliliter (EU/mL) | 95% Confidence Interval 4341 |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | 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 | 7812 ELISA Unit/milliliter (EU/mL) | 95% Confidence Interval 5120 |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | 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 | 5881 ELISA Unit/milliliter (EU/mL) | 95% Confidence Interval 3719 |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | 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 | 9273 ELISA Unit/milliliter (EU/mL) | 95% Confidence Interval 5596 |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | 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 | 6758 ELISA Unit/milliliter (EU/mL) | 95% Confidence Interval 4344 |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | 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 | 6069 ELISA Unit/milliliter (EU/mL) | 95% Confidence Interval 3780 |
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.
Time frame: 28 days post-dose 1 on Day 1 (Day 29)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 | 1325 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 | 1754 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 | 1392 Titers |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 | 2038 Titers |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 | 1878 Titers |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 | 1455 Titers |
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.
Time frame: From the first vaccination (Day 1) until 6 months post-dose 1 on Day 1 (Up to Day 184)
Population: Safety analyses set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1 | 2 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1 | 0 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1 | 0 Participants |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1 | 1 Participants |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1 | 0 Participants |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1 | 5 Participants |
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.
Time frame: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C]) | 0 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C]) | 0 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C]) | 0 Participants |
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.
Time frame: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)
Population: Safety analyses set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, and 3: Number of Participants With MAAEs Leading to Discontinuation | 0 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, and 3: Number of Participants With MAAEs Leading to Discontinuation | 0 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, and 3: Number of Participants With MAAEs Leading to Discontinuation | 0 Participants |
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.
Time frame: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)
Population: Safety analyses set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
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.
Time frame: From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 4, 5 and 6: Number of Participants With AESI (Including MIS-C) | 0 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 4, 5 and 6: Number of Participants With AESI (Including MIS-C) | 0 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 4, 5 and 6: Number of Participants With AESI (Including MIS-C) | 0 Participants |
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.
Time frame: From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57)
Population: Safety analyses set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 4, 5 and 6: Number of Participants With MAAEs Leading to Discontinuation | 0 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 4, 5 and 6: Number of Participants With MAAEs Leading to Discontinuation | 0 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 4, 5 and 6: Number of Participants With MAAEs Leading to Discontinuation | 0 Participants |
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.
Time frame: From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57)
Population: Safety analyses set included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 4, 5 and 6: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 4, 5 and 6: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 4, 5 and 6: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
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.
Time frame: 14 days post-dose 2 on Day 57 (Day 71)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 | 1187 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 | 1094 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 | 864 Titers |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 | 2386 Titers |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 | 2670 Titers |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 | 1742 Titers |
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.
Time frame: Groups 1-3: Days 1, 29, 57, 71, 184, 198, and 366; Groups 4-6: Days 1, 29, 57, 71 and 240
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | 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 | Day 366 | 5087 EU/mL |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | 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 | Day 71 | 4923 EU/mL |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | 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 | Day 57 | 5629 EU/mL |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | 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 | Day 184 | 4131 EU/mL |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | 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 | Day 1 | 255 EU/mL |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | 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 | Day 29 | 6533 EU/mL |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | 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 | Day 198 | 6782 EU/mL |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | 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 | Day 184 | 4765 EU/mL |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | 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 | Day 198 | 7656 EU/mL |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | 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 | Day 29 | 7812 EU/mL |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | 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 | Day 57 | 7450 EU/mL |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | 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 | Day 71 | 4679 EU/mL |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | 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 | Day 1 | 297 EU/mL |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | 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 | Day 366 | 4934 EU/mL |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | 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 | Day 29 | 5881 EU/mL |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | 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 | Day 71 | 4043 EU/mL |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | 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 | Day 198 | 10506 EU/mL |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | 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 | Day 184 | 3861 EU/mL |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | 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 | Day 57 | 4554 EU/mL |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | 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 | Day 366 | 6585 EU/mL |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | 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 | Day 1 | 338 EU/mL |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | 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 | Day 57 | 7034 EU/mL |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | 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 | Day 1 | 256 EU/mL |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | 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 | Day 29 | 9273 EU/mL |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | 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 | Day 71 | 8958 EU/mL |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | 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 | Day 240 | 4994 EU/mL |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | 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 | Day 240 | 5338 EU/mL |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | 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 | Day 71 | 8716 EU/mL |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | 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 | Day 1 | 200 EU/mL |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | 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 | Day 57 | 5650 EU/mL |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | 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 | Day 29 | 6758 EU/mL |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | 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 | Day 1 | 282 EU/mL |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | 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 | Day 240 | 3877 EU/mL |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | 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 | Day 71 | 6522 EU/mL |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | 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 | Day 29 | 6069 EU/mL |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | 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 | Day 57 | 4817 EU/mL |
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.
Time frame: Groups 1-3: Days 1, 29, 57, 71, 184, 198 and 366; Groups 4-6: Days 1, 29, 57, 71 and 240
Population: 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=\<LLOQ.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 184 | 1358 Titers |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 71 | 1187 Titers |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 1 | 105 Titers |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 366 | 1809 Titers |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 29 | 1325 Titers |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 57 | 1197 Titers |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 198 | 2496 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 1 | 149 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 29 | 1754 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 57 | 1743 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 71 | 1094 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 184 | 1702 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 198 | 2547 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 366 | 1783 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 71 | 864 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 1 | 114 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 366 | 2274 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 184 | 860 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 29 | 1392 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 198 | 4083 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 57 | 993 Titers |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 240 | 1867 Titers |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 71 | 2386 Titers |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 29 | 2038 Titers |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 1 | 112 Titers |
| Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 57 | 1662 Titers |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 29 | 1878 Titers |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 71 | 2670 Titers |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 240 | 1900 Titers |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 1 | 83 Titers |
| Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 57 | 1434 Titers |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 29 | 1455 Titers |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 240 | 1134 Titers |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 71 | 1742 Titers |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 57 | 1188 Titers |
| Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp | Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Day 1 | 127 Titers |
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.
Time frame: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With MAAEs Until 6 Months Post-booster Vaccination | 1 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With MAAEs Until 6 Months Post-booster Vaccination | 2 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With MAAEs Until 6 Months Post-booster Vaccination | 2 Participants |
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.
Time frame: From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With Solicited Local AEs for 7 Days Post-booster Vaccination | 19 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With Solicited Local AEs for 7 Days Post-booster Vaccination | 16 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With Solicited Local AEs for 7 Days Post-booster Vaccination | 17 Participants |
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.
Time frame: From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With Solicited Systemic AEs for 7 Days Post-booster Vaccination | 16 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With Solicited Systemic AEs for 7 Days Post-booster Vaccination | 14 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With Solicited Systemic AEs for 7 Days Post-booster Vaccination | 15 Participants |
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.
Time frame: From first vaccination on Day 1 up to Day 212 (28 days after booster Vaccination on Day 184)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With Unsolicited AEs for 28 Days Post-booster Vaccination | 6 Participants |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With Unsolicited AEs for 28 Days Post-booster Vaccination | 8 Participants |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2 and 3: Number of Participants With Unsolicited AEs for 28 Days Post-booster Vaccination | 10 Participants |
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.
Time frame: Days 184, 198 and 366
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Day 198 | 6782 EU/mL |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Day 184 | 4131 EU/mL |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Day 366 | 5087 EU/mL |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Day 198 | 7656 EU/mL |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Day 184 | 4765 EU/mL |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Day 366 | 4934 EU/mL |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Day 184 | 3861 EU/mL |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Day 366 | 6585 EU/mL |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers | Day 198 | 10506 EU/mL |
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.
Time frame: Days 184, 198 and 366
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Day 184 | 1358 Titers |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Day 366 | 1809 Titers |
| Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Day 198 | 2496 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Day 198 | 2547 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Day 366 | 1783 Titers |
| Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Day 184 | 1702 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Day 366 | 2274 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Day 184 | 860 Titers |
| Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo | Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Day 198 | 4083 Titers |