Trials / Completed
CompletedNCT05875961
Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults
A Phase 1, Randomized, Observer-Blind, Multi-Center, Dose Ranging Study to Evaluate the Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted or Non-Adjuvanted Cell Culture-derived A/H2N3 Subunit Influenza Virus Vaccine in Healthy Subjects 18 Years and Above
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 600 (actual)
- Sponsor
- Seqirus · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This Phase 1, randomized, observer-blind, dose-ranging clinical study is evaluating 6 different formulations of MF59-adjuvanted and non-adjuvanted H2N3 influenza vaccine. Approximately 600 healthy adult subjects are to be randomized into 1 of 6 possible treatment groups with 100 subjects per group, stratified by age group (born after or before 1968). Each subject will receive an influenza vaccine injection on Day 1 and Day 22. Subjects will be followed up for approximately 12 months after the second vaccine injection. The primary immunogenicity analysis is based on the Day 1, Day 8, Day 22, Day 29, and Day 43 serology data. The primary safety analysis is based on solicited local and systemic adverse events (AEs) reported within 10 days after each vaccination, unsolicited AEs reported within 3 weeks after each vaccination, and serious AEs (SAEs), medically attended AEs (MAAEs), AEs leading to withdrawal from the study, and AEs of special interest (AESIs) reported throughout the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Low dose A/H2N3c + standard dose MF59 | Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine |
| BIOLOGICAL | Intermediate dose A/H2N3c + standard dose MF59 | Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine |
| BIOLOGICAL | High dose A/H2N3c + standard dose MF59 | Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine |
| BIOLOGICAL | High dose A/H2N3c non-adjuvanted | Two intramuscular injections (3 weeks apart) of cell culture-derived non-adjuvanted H2N3 vaccine |
| BIOLOGICAL | Lowest dose A/H2N3c + high dose MF59 | Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine |
| BIOLOGICAL | Low dose A/H2N3c + high dose MF59 | Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine |
Timeline
- Start date
- 2023-06-15
- Primary completion
- 2024-11-15
- Completion
- 2024-11-15
- First posted
- 2023-05-25
- Last updated
- 2025-01-22
Locations
7 sites across 2 countries: United States, Philippines
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05875961. Inclusion in this directory is not an endorsement.