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A Phase 3, Randomized, Observer-Blinded, Study to Compare the Safety and Immunogenicity of 3 Lots of Trivalent Hemagglutinin Nanoparticle Influenza Vaccine With Matrix M™ Adjuvant in Participants ≥ 60 Years of Age
Phase 3 Study Comparing Safety and Immune Response of Three Batches of Novavax Flu Vaccine in older adult participants
Details
| Lead sponsor | Novavax |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | WITHDRAWN |
| Start date | 2024-11 |
| Completion | 2025-02-04 |
Conditions
- COVID-19
Interventions
- tNIV 1 and Matrix-M Adjuvant
Primary outcomes
- Safety- Solicited AEs over 7 days post-vaccination — 7 days post-vaccination
Numbers and proportions of participants with solicited local and systemic AEs over the 7 days post-vaccination. - Safety- Unsolicited AEs and MAAEs over 28 days post-vaccination — Day 0 to 28
Numbers and proportions of participants reporting unsolicited AEs and MAAEs over 28 days post-vaccination. - Safety-Treatment-related MAAEs, SAEs, and AESIs (including PIMMC) — Day-0 to 182
Numbers and proportions of participants with treatment-related MAAEs, AESIs (including PIMMCs), and SAEs over 6 months (approximately 182 days) post-vaccination. - Immunogenicity-HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMT — Day-0 to 28
HAI antibody titers specific for the HA receptor binding domains of vaccine response to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28. - Immunogenicity-HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMTR — Day-0 to 28
HAI antibody titers specific for the HA receptor binding domains of vaccine response to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28.