A Study to Evaluate Different Dose Levels ofAd26.COV2.S vaccine in Healthy Adolescents from 12 to 17 Years Inclusive
- Conditions
- Healthy adolescents for prevention of Covid-19
- Registration Number
- CTRI/2021/10/037564
- Lead Sponsor
- Janssen Vaccines and Prevention BV
- Brief Summary
The primary purpose of this study is to assess the safety,reactogenicity, and humoral immune response ofAd26.COV2.S or placebo administered intramuscularly(IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents (Part 1 and Part 2); and todemonstrate non-inferiority (NI) of immune responsesinduced by 1 dose or 2 doses or of a lower, to bedetermined, dose level of Ad26.COV2.S in adolescentsversus 1 or 2 doses of Ad26.COV2.S in young adults(Part 2).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 4350
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 COVID19 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 or legal guardian are available and willing to participate for the duration of the study visits and follow up Each participant or participant’s parent or legal guardian must have access to a consistent means of contact either by telephone contact or email or computer.
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 or 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Participants with Solicited 7 days post-dose 1 (Day 8) | ,7 days post-dose 2 (Day | 64) Parts 1 and 2: Number of 7 days post-dose 1 (Day 8) | ,7 days post-dose 2 (Day | 64) Local Adverse Events (AEs) 7 days post-dose 1 (Day 8) | ,7 days post-dose 2 (Day | 64) 7 Days Post-dose 1 & 2,Parts 1 and 2: 7 days post-dose 1 (Day 8) | ,7 days post-dose 2 (Day | 64)
- Secondary Outcome Measures
Name Time Method Parts 1 and 2: Severe Acute Respiratory Syndrome Parts 1 and 2: SARS-CoV-2 Neutralizing Antibody Titers as Measured by VNA Titers
Trial Locations
- Locations (11)
Acharya Vinoba Bhave Rural Hospital
🇮🇳Wardha, MAHARASHTRA, India
BAPS Pramukh Swami Hospital
🇮🇳Surat, GUJARAT, India
Cheluvamba Hospital
🇮🇳Mysore, KARNATAKA, India
Dr. D.Y.Patil Medical College Hospital and Research Center
🇮🇳Pune, MAHARASHTRA, India
GSVM Medical College Swaroop Nagar
🇮🇳Nagar, UTTAR PRADESH, India
JSS Hospital
🇮🇳Mysore, KARNATAKA, India
KEM Hospital Research Centre
🇮🇳Pune, MAHARASHTRA, India
Medanta –The Medicity Hospital
🇮🇳Gurgaon, HARYANA, India
Sir Ganga Ram Hospital
🇮🇳Delhi, DELHI, India
Sri Ramchandra Medical College & Research Institute Sri Ramachandra Institute
🇮🇳Chennai, TAMIL NADU, India
Scroll for more (1 remaining)Acharya Vinoba Bhave Rural Hospital🇮🇳Wardha, MAHARASHTRA, IndiaDr Sachin DamkePrincipal investigator9323234457buntydamke@gmail.com