Phase 2
Completed N=170
A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults
Influenza Prevention
Source: ClinicalTrials.gov NCT05901636 ↗
Enrolled (actual)
170
Serious AEs
1.2%
Results posted
Sep 2025
Primary outcomePrimary: Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 — 5; 12; 3; 13 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 |
5; 12; 3; 13; 6; 14 | — |
| PRIMARY Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 |
5; 9; 5; 8; 2; 5 | — |
| PRIMARY Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 |
1.0; 1.0; 1.0; 1.0; 1.0; 1.0 | — |
| PRIMARY Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 |
1.0; 1.0; 1.0; 2.0; 2.0; 1.5 | — |
| PRIMARY Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1 |
7; 12; 6; 9; 7; 12 | — |
| PRIMARY Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2 |
4; 8; 7; 9; 6; 8 | — |
| PRIMARY Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 |
0; 0; 0; 1; 1; 0 | — |
| PRIMARY Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 |
2.0; 3.0; 1.5; 1; 1.5; 4.5 | — |
| PRIMARY Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 |
6.0; 6.0; 1.0; 1.0; 1.0; 4.0 | — |
| PRIMARY Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 |
7; 12; 6; 9; 7; 12 | — |
| PRIMARY Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 |
4; 8; 7; 9; 6; 8 | — |
| PRIMARY Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 |
1; 1; 0; 1; 0; 1 | — |
| PRIMARY Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 |
1; 1; 2; 3; 2; 2 | — |
| PRIMARY Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 |
0; 0; 0; 1; 1; 0 | — |
| PRIMARY Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1 |
57.0; 11.0; 1.0; 11.0; 1.0 | — |
| PRIMARY Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 |
34.0; 3.0; 20.0; 7.0; 252.0; 6.0 | — |
| PRIMARY Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) |
2919; 2990; 3240; 4468; 3998; 5468 | — |
Eligibility Criteria
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 screening tests are outside the laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the US FDA toxicity scale the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Exclusion Criteria
- Contraindication to IM injections and blood draws, example, bleeding disorders
- Clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
- History of severe allergic reaction (for example, anaphylaxis) or other serious adverse reactions to vaccines or vaccine excipients (specifically the excipients of the study vaccine[s])
- Abnormal function of the immune system resulting from: a) clinical conditions (example, autoimmune disease or immunodeficiency) or their treatments expected to have an impact on the immune response elicited by the study vaccine; b) chronic or recurrent use of systemic corticosteroids within 2 months before administration of study vaccine and during the study; c) administration of antineoplastic and immunomodulating agents or radiotherapy expected to have an impact on the immune response elicited by the study vaccine within 6 months before administration of study vaccine and during the study
- History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
- Received treatment with immunoglobulins (including monoclonal antibodies) expected to impact the vaccine-induced immune response in the 2 months or blood products in the 3 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study.
- Received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine, or received an investigational biological product within 3 month
Data sourced from ClinicalTrials.gov (NCT05901636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.