drugset / Trial / NCT05875701
Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines
RandomizedParallel-groupOpen-labelPrevention
Summary
This is an open-label Phase 3 study evaluating the immunogenicity and safety of Novavax vaccine(s) with Matrix-M™ adjuvant (ancestral strain NVX-CoV2373 and an alternative strain and/or multivalent Novavax vaccine) as booster doses following a series of primary and booster doses of authorized/approved mRNA vaccines followed by a single booster dose of NVX-CoV2373 in the Novavax 2019nCoV-307 study (NCT05463068).
Timeline
- Start
- 2023-03-28
- Primary completion
- 2023-11-11
- Completion
- 2023-11-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NVX-CoV2373 | Vaccine | 5 ug | — |
| Subject | NVX-CoV2373 | Vaccine | 50 ug | — |
| Subject | NVX-CoV2373 | Vaccine | 0.5 ml | — |
| Subject | SARS-CoV-2 rS antigen/Matrix-M Adjuvant | Unknown | 5 ug | Intramuscular |
| Subject | SARS-CoV-2 rS antigen/Matrix-M Adjuvant | Unknown | 50 ug | Intramuscular |
| Subject | SARS-CoV-2 rS antigen/Matrix-M Adjuvant | Unknown | 0.5 ml | Intramuscular |