NCT06291857Phase 3Completed

A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine

Study sponsor: Novavax

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-12-24Actual

Enrollment · participants9320Actual

Source updated2026-06-05Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-06-05 · 3 fields changed

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~26 Jul 2026~~

+ After

24 Dec 2025

Recruitment status changed

− Before

~~Active not recruiting~~

+ After

Completed

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Study details

Conditions studied

COVID-19

Treatments or interventions studied

CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M AdjuvantBiologicalAlso known as COVID-19 and influenza combination
Novavax COVID-19 VaccineBiologicalAlso known as Novavax SARS-CoV-2 rS vaccine
tNIV VaccineBiologicalAlso known as Trivalent Nanoparticle Influenza Hemagglutinin Vaccine
Fluzone High DoseBiologicalAlso known as Fluzone HD

Primary outcomes · main study measures

Read the study measures

measure: Numbers of participants with solicited local and systemic adverse events (AEs); description: Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.; timeFrame: Day 7; measure: Numbers of participants reporting unsolicited AEs and medically attended adverse events (MAAEs).; description: Numbers of participants reporting unsolicited AEs and MAAEs over 21 days post-vaccination.; timeFrame: Day 28; measure: 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); description: Numbers of participants with treatment-related MAAEs, AESIs (including PIMMC and myocarditis and/or pericarditis), and SAEs will be collected for 12 months (approximately 364 days) post-vaccination.; timeFrame: Day 0 to Day 364; measure: Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT; description: Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Days 0 and 28; timeFrame: Days 0 and 28; measure: Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMTR; description: Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Days 28; timeFrame: Day 28; measure: 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; description: Percentage of Participants With a (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose for 3 vaccine-homologous influenza strain on Days 28; timeFrame: Day 28; measure: Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT; description: Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28; timeFrame: Day 28; measure: Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMTR; description: Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28; timeFrame: Day 28; measure: 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; description: Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28; timeFrame: Day 28; measure: 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; description: Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28; timeFrame: Day 28; measure: 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; description: Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28; timeFrame: Day 28; measure: 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; description: Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28; timeFrame: Day 28

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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