A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine
← catalyst calendarSponsored by Novavax (industry) · NVAX — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Single · Prevention
Enrollment
9,320actual
Sites
58
Countries
Australia, New Zealand
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-12-09 | actual | When the study began enrolling |
| Primary completion | 2025-12-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-09 | actual | The whole study's end, after follow-up |
| First posted | 2024-03-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- COVID-19
Interventions
- Biological: CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant — also filed as COVID-19 and influenza combination
- Biological: Novavax COVID-19 Vaccine — also filed as Novavax SARS-CoV-2 rS vaccine
- Biological: tNIV Vaccine — also filed as Trivalent Nanoparticle Influenza Hemagglutinin Vaccine
- Biological: Fluzone High Dose — also filed as Fluzone HD
Primary outcomes
what the primary-completion date above is the date OFNumbers of participants with solicited local and systemic adverse events (AEs)
measured Day 7
Numbers of participants reporting unsolicited AEs and medically attended adverse events (MAAEs).
measured Day 28
Treatment-related MAAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs) (including potential immune-mediated medical conditions [PIMMCs] and myocarditis and/or pericarditis)
measured Day 0 to Day 364
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT
measured Days 0 and 28
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMTR
measured Day 28
Percentage of Participants With a (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose for 3 vaccine-homologous influenza strains Expressed as SCR
measured Day 28
Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT
measured Day 28
Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMTR
measured Day 28
Percentage of Participants With a (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as SCR
measured Day 28
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of homologous influenza A and B strains expressed as GMT
measured Day 28
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of homologous influenza A and B strains expressed as GMTR
measured Day 28
Percentage of Participants with (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of homologous influenza A and B strains expressed as SCR
measured Day 28
Permalink · NVAX's whole pipeline · Catalyst calendar · Every registered study · What changed