A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Childre

Phase 1

• Conditions: Protection against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.0Level: HLTClassification code 10084510Term: Coronavirus infectionsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.1Level: LLTClassification code 10084529Term: 2019 novel coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2024-000001-33-Outside-EU/EEA
• Lead Sponsor: BioNTech SE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-07
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Participants are eligible to be included in the study only if all of the substudy-specific inclusion criteria are met.
For Substudy A, see Section 10.7.5.1. of the Study Protocol.
For Substudy B, see Section 10.8.5.1. of the Study Protocol.
For Substudy C, see Section 10.9.5.1. of the Study Protocol.
For Substudy D, see Section 10.10.5.1. of the Study Protocol.
For Substudy E, see Section 10.11.5.1. of the Study Protocol.

Some inclusion criteria are common to all substudies: participants (and their parent(s)/legal guardian(s) willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures; participants should be healthy; and participants (or their parent[s]/legal guardian[s]) must be capable of giving personal signed informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 3692
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

Participants are excluded from the study if any of the substudy-specific exclusion criteria apply.
For Substudy A, see Section 10.7.5.2. of the Study Protocol.
For Substudy B, see Section 10.8.5.2. of the Study Protocol.
For Substudy C, see Section 10.9.5.2. of the Study Protocol.
For Substudy D, see Section 10.10.5.2. of the Study Protocol.
For Substudy E, see Section 10.11.5.2. of the Study Protocol.

Some exclusion criteria are common to all substudies: Previous or current diagnosis of MIS-C; history of severe adverse reactions associated with a vaccine and/or severe allergic reaction to any component of the study vaccination; immunocompromised individuals; or participants with bleeding diathesis; Other medical or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified