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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-27

Study Completion Date

2023-08-14

Brief Summary

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The primary purpose of this study is to assess the safety, reactogenicity, and humoral immune response of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents.

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Detailed Description

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Available safety, immunogenicity and efficacy data from the Ad26.COV2.S vaccine development program supports initiating evaluation of Ad26.COV2.S in the pediatric population. Ad26.COV2.S will be evaluated in the pediatric population through a dose-confirmation approach. Ad26.COV2.S (also known as Ad26COVS1, VAC31518, JNJ-78436735) is a monovalent vaccine composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus(-2) (SARS-CoV-2) spike (S) protein, stabilized in its prefusion conformation. The study duration from screening until the last follow-up visit will be, excluding the 28-day screening phase, 8 months (Groups 4-6) to 12 months (Groups 1-3), consisting of 12-month study duration comprising a study period (6-months) including vaccination with a 1 active dose and a placebo vaccination (56-day interval), followed by a booster vaccination at 6 months and follow-up (safety and immunogenicity) until at least 6 months after booster vaccination (Groups 1-3) and 8 month study duration comprising 2 active doses (56-day interval) and follow-up (safety and immunogenicity) until at least 6 months after second vaccination (Groups 4-6). Assessments like immunogenicity (such as humoral and cellular immune responses), safety and reactogenicity (such as adverse events \[AEs\] monitoring) will be performed in this study. Other safety assessments include vital signs measurements (heart rate, supine systolic and diastolic blood pressure, respiratory rate, and body temperature) and physical examinations. The overall study duration from enrolment of the first participant until study completion is expected to be up to 1 year 11 months.

Conditions

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Coronavirus Disease-2019 (COVID-19) Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: Ad26.COV2.S Dose Level 1 (Lower Volume): 1-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.

Group Type EXPERIMENTAL