CompletedPhase 3

Immunogenicity Trial of 3 Influenza Vaccines

Singapore366 participantsStarted 2022-09-29

Plain-language summary

This study is a prospective randomised trial of 3 influenza vaccine formulations with different manufacturing processes: 1) egg-grown (QIV-E); 2) cell-grown (QIV-C); and 3) recombinant protein (QIV-R). The main objective is to compare the antibody responses following influenza vaccination among these 3 vaccines to determine whether recombinant vaccines offer superior protection over standard egg or cell-based formulations. The attenuating effects of prior vaccination on vaccine immunogenicity will also be evaluated. Hypothesis: Vaccination with recombinant vaccine results in better antibody responses, particularly against A(H3N2) viruses, than either standard egg-grown vaccines or cell-grown vaccines.

Who can participate

Age range

21 Years – 49 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: * Able to provide informed consent * Willing and able to provide 4 blood samples at D0, 14, 150 and 330 post-vaccination * Has not received influenza vaccine for at least 6 months * Willing to provide current mobile phone number for SMS reminders Exclusion Criteria: * Known contraindication(s) for QIV (e.g. hypersensitivity to vaccine component (including eggs)). * Recently (last 7 days) or currently ill or has a fever above 38 degrees celsius * Cannot recall if they were vaccinated against influenza during more or less than two of the preceding five years. Vaccinated during two of the preceding five years. * Hypogammaglobulinaemia on immunoglobulin replacement * Undergoing immunosuppressive therapies including corticosteroids

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

Antibody titres against the 4 vaccine antigens

Timeframe: Day 0, 14, 150, 330

Trial details

NCT IDNCT05479370

SponsorTan Tock Seng Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-14

View on ClinicalTrials.gov More Influenza Vaccination trials