NCT05372588

Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines

A Multi-Part, Phase 3, Randomized, Observer Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adults Previously Vaccinated With Other COVID-19 Vaccines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,340 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a Multi-Part, Phase 3, randomized, observer-blinded study to evaluate the safety and immunogenicity of booster doses of Omicron subvariant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccines (SARS-CoV-2 rS) adjuvanted with Matrix-M™ adjuvant (NVX-CoV2515 \[BA.1\] and NVX-CoV2540 \[BA.5\]) and bivalent (NVX-CoV2373 \[prototype\] + Omicron subvariant) SARS-CoV-2 rS vaccines (NVX-CoV2373 + NVX CoV2515 and NVX CoV2373 + NVX CoV2540) in previously vaccinated adults 18 years of age and older.

Conditions

• COVID-19
• SARS CoV 2 Infection

Interventions

Type	Name	Description
DRUG	NVX-CoV2515	Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL).
DRUG	NVX-Cov2373	Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).
DRUG	NVX-CoV2373 + NVX-CoV2515	Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.
DRUG	NVX-CoV2540	Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).
DRUG	NVX-CoV2373 + NVX-CoV2540	Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.

Timeline

• Start date: 2022-05-25
• Primary completion: 2022-07-17
• Completion: 2024-04-07
• First posted: 2022-05-12
• Last updated: 2024-04-23

Locations

19 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study