A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.