A Study to Evaluate Different Dose Levels ofAd26.COV2.S vaccine in Healthy Adolescents from 12 to 17 Years Inclusive

Phase 2

• Registration Number: CTRI/2021/10/037564
• Lead Sponsor: Janssen Vaccines and Prevention BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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 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

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 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