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Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants

NCT05004181 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1380

Last updated 2024-11-22

Study results available
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Summary

This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who had received two doses of the parent vaccine BNT162b2 at 30 µg, at least 6 months after the second dose of BNT162b2. It also evaluated the safety and immunogenicity of a three-dose regimen of BNT162b2 (B.1.1.7 + B.1.617.2) in participants who had not received prior Coronavirus Disease 2019 (COVID-19) vaccination. In addition, the safety and immunogenicity of BNT162b2 (B.1.1.529.1) or BNT162b2 given as a third or fourth vaccine dose to RNA COVID-19 vaccine-experienced participants with history of SARS-CoV-2 Omicron variant infection was evaluated and contrasted with the natural immune response reached after infection with the SARS-CoV-2 Omicron variant in RNA COVID-19 vaccine-experienced participants.

Conditions

Interventions

BIOLOGICAL

BNT162b2

Intramuscular (IM)

BIOLOGICAL

Multivalent BNT162b2 (B.1.1.7 + B.1.617.2)

Intramuscular (IM)

BIOLOGICAL

Monovalent BNT162b2 (B.1.1.7)

Intramuscular (IM)

BIOLOGICAL

Monovalent BNT162b2 (B.1.617.2)

Intramuscular (IM)

BIOLOGICAL

Monovalent BNT162b2 (B.1.1.529.1)

Intramuscular (IM)

OTHER

Observational

No vaccination within 3 months after Visit 1.

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-25
Primary Completion
2023-08-16
Completion
2023-10-04
FDA Drug
Yes

Countries

  • United States
  • Germany
  • South Africa
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05004181 on ClinicalTrials.gov