Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
A Randomized, Observer-Blinded, Phase 3 Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
Sponsor: Novavax
Listed as NCT05463068, this observational or N/A phase trial focuses on COVID-19 and SARS-CoV-2 Infection and remains completed. Sponsored by Novavax, it has been updated 8 times since 2022, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Study Description(click to expand)This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373). The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive. Participants will be screened at baseline with the goal of enrolling approximately 900 previously vaccinated participants. Participants will be randomized 1:1:1 to receive 1 dose of the vaccine from 1 of 3 different lots, given on Day 1, at a dose level of 5 µg of antigen with 50 µg of Matrix-M adjuvant. All participants will remain on study for immunogenicity and safety data collection through 28 days following the vaccination.
This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373). The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive. Participants will be screened at baseline with the goal of enrolling approximately 900 previously vaccinated participants. Participants will be randomized 1:1:1 to receive 1 dose of the vaccine from 1 of 3 different lots, given on Day 1, at a dose level of 5 µg of antigen with 50 µg of Matrix-M adjuvant. All participants will remain on study for immunogenicity and safety data collection through 28 days following the vaccination.
Status Flow
Change History
8 versions recorded-
Apr 18, 2026 — Present [daily]
Completed
Phase: PHASE3 → None
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Sep 2025 — Apr 2026 [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Aug 2023 — Jul 2024 [monthly]
Completed PHASE3
▶ Show 3 earlier versions
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Jun 2023 — Aug 2023 [monthly]
Completed PHASE3
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May 2023 — Jun 2023 [monthly]
Completed PHASE3
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Sep 2022 — May 2023 [monthly]
Completed PHASE3
First recorded
Jul 2022
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373).The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive.
Contact Information
- Novavax
For direct contact, visit the study record on ClinicalTrials.gov .