CompletedPhase 3

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

Australia, New Zealand9,320 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 range

65 Years – 75 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 7

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

Timeframe: 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)

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: 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

Timeframe: Day 28

Trial details

NCT IDNCT06291857

SponsorNovavax

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-24

View on ClinicalTrials.gov More COVID-19 trials

Plain-language summary

Who can participate

Age range

65 Years – 75 Years

Sex

ALL

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.

What they're measuring

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

Timeframe: Day 7

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

Timeframe: Day 28

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: 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

Timeframe: Day 28

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria