A Study to Evaluate Additional Dose(s) of BNT162b2 in Healthy Individuals Previously Vaccinated With BNT162b2

Phase 1

• Conditions: Protection against COVID-19; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-005197-25-DE
• Lead Sponsor: BioNTech SE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-29
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 13900

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.
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: 1188
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10172
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2676

Exclusion Criteria

Participants are excluded from the study if any of the substudy-specific exclusion criteria apply.
Some exclusion criteria are common to all substudies: participants with medical or psychiatric conditions that may increase the risk of study participation; history of severe adverse reactions associated with a vaccine and/or severe allergic reaction to any component of the study vaccination; previous clinical or microbiological diagnosis of COVID-19; immunocompromised individuals; or participants with bleeding diathesis.
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.

Study & Design

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