drugset / Trial / NCT05925127

Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines

NCT05925127

Phase 2/3 Completed 994 enrolled Novavax
RandomizedCrossoverDouble-blindPrevention

Summary

This is a Phase 2/3, randomized, double-blind study to evaluate the safety and immunogenicity of different booster dose levels of the monovalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle (SARS-CoV-2 rS) vaccines with Matrix-M™ adjuvant (NVX-CoV2373 \[prototype Wuhan vaccine with Matrix-M adjuvant\] or NVX-CoV2601 \[Omicron XBB.1.5 subvariant vaccine with Matrix-M adjuvant\]).

Timeline

Start
2023-10-16
Primary completion
2024-05-21
Completion
2024-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Bivalent BA.4/5 Messenger RNA (mRNA) Intramuscular
Subject MIVALSECOVATEIN Vaccine 5 ug Intramuscular
Subject MIVALSECOVATEIN Vaccine 35 ug Intramuscular
Subject MIVALSECOVATEIN Vaccine 50 ug Intramuscular
Subject NVX-CoV2373 Vaccine 5 ug

Indications