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 range18 Years – 45 Years

SexALL

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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…

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

Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1

Trial details

NCT IDNCT05901636

SponsorJanssen Vaccines & Prevention B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-19

Results submitted2025-08-18

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