At a glance
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A Phase II Trial to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Monovalent and Multivalent RNA-based Vaccines in Healthy Subjects
In Brief
A Phase 2 clinical trial evaluating BNT162b2, Multivalent BNT162b2 (B.1.1.7 + B.1.617.2), and 4 other interventions for SARS-CoV-2 Infection and 3 related conditions. Completed, enrolled 1,380 participants across 35 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Intramuscular (IM)
Intramuscular (IM)
Intramuscular (IM)
Intramuscular (IM)
Intramuscular (IM)
No vaccination within 3 months after Visit 1.