CompletedPhase 1/2

A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults

United States170 participantsStarted 2023-05-17

Plain-language summary

The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (\>=) 18 to less than or equal to (\<=) 45 years of age.

Who can participate

Age range

18 Years – 45 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: * Must be healthy as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening * Contraceptive (birth control) use by female participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies. Before randomization, participants who were born female must be either: a) not of childbearing potential; b) of childbearing potential and practicing a highly effective method of contraception and agreeing to remain on such a method of contraception from signing the informed consent until 3 months after the last dose of study vaccine. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Highly effective methods for this study include: hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion/ligation procedures, vasectomized partner (the vasectomized partner should be the sole partner for that participant), and sexual abstinence * All female participants of childbearing potential must: a) have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; b) have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration * Must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory s…

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

Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1

Timeframe: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)

Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2

Timeframe: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)

Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1

Timeframe: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)

Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2

Timeframe: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)

Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1

Timeframe: From Day 1 up to Day 365

Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2

Timeframe: From Day 57 up to Day 365

Trial details

NCT IDNCT05901636

SponsorJanssen Vaccines & Prevention B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-19

Results submitted2025-08-18

View on ClinicalTrials.gov More Influenza Prevention trials