Phase 3 Study to Evaluate a Single Booster of the NVX-CoV2373 COVID19 Vaccine in Adults
Status:
Not yet recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
Summary
This is an observer-blinded Phase 3 study to evaluate the safety and immunogenicity of a
single booster dose of the Novavax severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine adjuvanted with
Matrix-MTM (NVX-CoV2373) in adults previously vaccinated with the BBIBP-CorV vaccine. The
study will enroll approximately1,000 participants >18 years of age. All participants will be
randomized in a 1:1 ratio to receive a single booster dose of NVX-CoV2373 or the BBIBP-CorV
vaccine. All participants will receive the booster dose on Day 0 and remain on study for
immunogenicity and safety data collection through Day 180. An interim analysis will be
performed of safety and immunogenicity data gathered through Day 28.