A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive (HORIZON 2)
Coronavirus Disease-2019 (COVID-19) Prevention
About this trial
This is an interventional prevention trial for Coronavirus Disease-2019 (COVID-19) Prevention
Eligibility Criteria
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)
Sites / Locations
- CIPREC
- Hospital de Ninos de Cordoba
- Hospital del Niño Jesús
- Universidade Federal De Minas Gerais - Hospital das Clínicas
- Santa Casa de Misericordia de Belo Horizonte
- Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
- CPQuali Pesquisa Clinica LTDA ME
- Sri ramchandra Medical College & Research Institute
- JSS Hospital
- Supe Heart And Diabetes Hospital and Research Center
- BAPS Pramukhswami Hospital
- CAIMED Investigacion en salud S.A de C.V.
- Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
- Ndlovu Elandsdoorn Site
- Shandukani Research Centre
- Setshaba Research Centre
- Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
- University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Group 1: Ad26.COV2.S Dose Level 1 (Lower Volume): 1-Dose Regimen
Group 2: Ad26.COV2.S Dose Level 2: 1-Dose Regimen
Group 3: Ad26.COV2.S Dose Level 3: 1-Dose Regimen
Group 4: Ad26.COV2.S Dose Level 1: 2-Dose Regimen
Group 5: Ad26.COV2.S Dose Level 2: 2-Dose Regimen
Group 6: Ad26.COV2.S Dose Level 3: 2-Dose Regimen
Participants will receive 1-dose of Ad26.COV2.S at dose level 1 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184.
Participants will receive 1-dose of Ad26.COV2.S at dose level 2 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184.
Participants will receive 1-dose of Ad26.COV2.S at dose level 3 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184.
Participants will receive 2-dose of Ad26.COV2.S at dose level 1 on Day 1 and 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination.
Participants will receive 2-doses of Ad26.COV2.S at dose level 2 on Day 1 and Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination.
Participants will receive 2-doses of Ad26.COV2.S at dose level 3 on Day 1 and Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination.