NCT04611802

A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2

Completed Phase 3 Last updated 21 December 2023

What this trial tests

Phase 3 trial testing SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period) in SARS-CoV Infection in 33,000 participants. Completed in 15 December 2023.

Timeline

27 December 2020

Primary endpoint
10 April 2023

15 December 2023

Quick facts

Lead sponsor	Novavax
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	prevention
Enrollment	33,000
Start date	27 December 2020
Primary completion	10 April 2023
Estimated completion	15 December 2023
Sites	154 locations across Puerto Rico, United States, Mexico

Drugs / interventions tested

• SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period) — full drug profile →
• Placebo (Initial Vaccination Period)
• SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period) — full drug profile →
• Placebo (Crossover Vaccination period)
• SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination) — full drug profile →
• SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster Vaccination) — full drug profile →

Conditions studied

• SARS-CoV Infection — all drugs for SARS-CoV Infection →
• Covid19 — all drugs for Covid19 →

Sponsor

Novavax — full company profile →

Who can join

12 and older, any sex, with SARS-CoV Infection or Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants. Additionally providing a Booster Dose to fully vaccinated participants. A substudy is to be conducted at selected sites to evaluate the safety and immunogenicity of a fourth dose (second booster) of NVX-CoV2373 in adults and adolescents, previously fully vaccinated and subsequently boosted with a third dose (first booster)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine.
   Heath PT, Galiza EP, Baxter DN, Boffito M, et al · · 2021 · cited 865× · PMID 34192426 · DOI 10.1056/nejmoa2107659
2. Viral targets for vaccines against COVID-19.
   Dai L, Gao GF. · · 2021 · cited 836× · PMID 33340022 · DOI 10.1038/s41577-020-00480-0
3. Progress of the COVID-19 vaccine effort: viruses, vaccines and variants versus efficacy, effectiveness and escape.
   Tregoning JS, Flight KE, Higham SL, Wang Z, et al · · 2021 · cited 827× · PMID 34373623 · DOI 10.1038/s41577-021-00592-1
4. SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates.
   Kyriakidis NC, López-Cortés A, González EV, Grimaldos AB, et al · · 2021 · cited 507× · PMID 33619260 · DOI 10.1038/s41541-021-00292-w
5. Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico.
   Dunkle LM, Kotloff KL, Gay CL, Áñez G, et al · · 2022 · cited 362× · PMID 34910859 · DOI 10.1056/nejmoa2116185
6. COVID-19 vaccines: rapid development, implications, challenges and future prospects.
   Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. · · 2021 · cited 240× · PMID 33677814 · DOI 10.1007/s13577-021-00512-4
7. Efficacy and safety of COVID-19 vaccines.
   Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
8. A Comprehensive Review of the Global Efforts on COVID-19 Vaccine Development.
   Li Y, Tenchov R, Smoot J, Liu C, et al · · 2021 · cited 215× · PMID 34056083 · DOI 10.1021/acscentsci.1c00120