Active — Not RecruitingPhase 3

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

Australia9,320 participantsStarted 2024-12-09

Plain-language summary

This is a medical study where participants will be randomly assigned to receive either a new combination vaccine that protects against both COVID-19 and the flu, or a standard flu vaccine. The researchers conducting the study won't know which vaccine each participant receives, ensuring their observations are unbiased. This study compares the new combination vaccine to an already available flu vaccine to see how well it works. It's a large-scale, final-stage study designed to thoroughly check how well the vaccines trigger an immune response (immunogenicity) and how safe they are.

Who can participate

Age range65 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willing and able to give informed consent prior to study enrollment.
✓. Medically stable adult male or female ≥ 65 years of age at Screening.
✓. Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:
✓. Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity;
✓. Absence of medical events qualifying as SAEs within 3 months; and
✓. Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the Investigator.
✓. The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at Screening.
✓. Participant must be able to receive an injection in the deltoid of at least 1 arm.

Exclusion criteria

✕. History of laboratory-confirmed (by polymerase chain reaction \[PCR\], rapid antigen test, or rapid molecular assay) COVID-19, asymptomatic SARS-CoV-2 infection, or influenza within ≤ 8 weeks prior to Screening.

What they're measuring

Numbers of participants with solicited local and systemic adverse events (AEs)

Timeframe: 7 days post-vaccination

Numbers of participants reporting unsolicited AEs and medically attended adverse events (MAAEs).

Timeframe: 28 days post-vaccination

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)

Timeframe: 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

Timeframe: 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

Timeframe: Days 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

Timeframe: Days 28

Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT

Trial details

NCT IDNCT06291857

SponsorNovavax

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-26

View on ClinicalTrials.gov More COVID-19 trials

Plain-language summary

Who can participate

Age range65 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willing and able to give informed consent prior to study enrollment.
✓. Medically stable adult male or female ≥ 65 years of age at Screening.
✓. Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:
✓. Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity;
✓. Absence of medical events qualifying as SAEs within 3 months; and
✓. Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the Investigator.
✓. The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at Screening.
✓. Participant must be able to receive an injection in the deltoid of at least 1 arm.

Exclusion criteria

✕. History of laboratory-confirmed (by polymerase chain reaction \[PCR\], rapid antigen test, or rapid molecular assay) COVID-19, asymptomatic SARS-CoV-2 infection, or influenza within ≤ 8 weeks prior to Screening.

What they're measuring

Numbers of participants with solicited local and systemic adverse events (AEs)

Timeframe: 7 days post-vaccination

Numbers of participants reporting unsolicited AEs and medically attended adverse events (MAAEs).

Timeframe: 28 days post-vaccination

Timeframe: 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

Timeframe: 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

Timeframe: Days 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

Timeframe: Days 28

Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT