Healthy Volunteers (Prevention of SARS-CoV-2-mediated COVID-19) MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865
Conditions
Sponsors
Janssen Vaccines & Prevention B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant's age is 12 to 17 years of age at the time of first vaccination 2. 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) 3. 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 4. Participant and/or parent(s)/legal guardian(s) are available and willing to participate for the duration of the study visits and follow-up 5. 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 Are the trial subjects under 18? yes Number of subjects for this age range: 300 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participant has a history of malignancy, bone marrow transplant, or solid organ transplant within 5 years before screening 2. 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) 3. 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 4. 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 5. 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 |
|---|---|
| Main Objective: 1. To assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose regimen (at 2.5×10^10 vp per 0.25 mL, 1.25×10^10 vp, and 0.625×10^10 vp dose level) or as a 2-dose (56-day interval) regimen (2.5×10^10 vp per 0.5 mL, 1.25×10^10 vp, and 0.625×10^10 vp dose levels) in adolescents. 2. To assess the humoral immune response of Ad26.COV2.S administered IM as a 1-dose regimen (at 2.5×10^10 vp per 0.25 mL, 1.25×10^10 vp, and 0.625×10^10 vp dose level)or as a 2-dose (56-day interval) regimen (2.5×10^10 vp per 0.5 mL, 1.25×10^10 vp, and 0.625×10^10 vp dose levels) in adolescents. ;Secondary Objective: 1. To assess the humoral immune response to 3 dose levels of Ad26.COV2.S (2.5×10^10 vp, 1.25×10^10 vp, or 0.625×10^10 vp) and regimens in all study groups, at all blood collection timepoints. 2. To assess the safety and reactogenicity of Ad26.COV2.S administered IM as a booster in adolescent participants (Groups 1-3). 3. To evaluate the humoral immune response in adolescent participants who receive a booster dose during the study, pre-boost and at selected time points post booster vaccination (Groups 1-3).;Primary end point(s): - Solicited local and systemic adverse events (AEs) for 7 days post-dose 1 and 2. - Unsolicited AEs for 28 days post-dose 1 and 2. - Medically-attended adverse events (MAAEs) from the first vaccination until 6 months post-dose 1 or post-dose 2. MAAEs leading to discontinuation will be collected during the entire study. - Serious adverse events (SAEs) from the first vaccination until the end of the study. - Adverse events of special interest (AESI) from first vaccination until end of the study (incl. MIS-C). - Serological response to vaccination as measured by spike-enzyme-linked immunosorbent assay (S-ELISA) (ELISA; Units/mL [EU/mL]) or equivalent assay, or virus neutralization assay (VNA) titers at 28 days post-dose 1 and 14 days post-dose 2. ;Timepoint(s) of evaluation of this end point: AEs: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Serological response to vaccination measured by binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins (eg, S protein) as measured by ELISA (or equivalent assay), and/or - Serological response to vaccination measured by neutralizing antibody titers to SARS-CoV-2 (VNA). - Solicited local and systemic AEs for 7 days post-booster. - Unsolicited AEs for 28 days post-booster. - MAAEs from the booster until 6 months post-vaccination. - Serological response to post-booster vaccination measured by binding (S-ELISA and/or equivalent assay) and/or neutralizing (VNA) antibody titers ;Timepoint(s) of evaluation of this end point: S-ELISA/VNA: Groups 1-3: Days 1, 29, 57, 71, 184, 198, and 366; Groups 4-6: Days 1, 29, 57, 71 and 240; Post-booster: Days 184, 198 and 366 AEs: 7 and 28 days post-booster MAAES: 6 months post-booster | — |
Countries
Argentina, Brazil, India, Mexico, South Africa
Contacts
Public ContactClinical Registry Group
Janssen Research & Development
Outcome results
None listed