Trials / Completed
CompletedNCT04144179
Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens in Healthy Adult Subjects 18 to 30 Years of Age
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years – 30 Years
- Healthy volunteers
- Accepted
Summary
The primary objectives of the study are: * To describe the safety profile of the different quadrivalent recombinant influenza vaccine (RIV) formulations. * To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (HA) (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives of the study are: * To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations). * To describe HAI and SN antibody responses in each group against each of the H3 antigens. * To compare the HAI and SN antibody responses for the groups with different H3 antigens to the control group.
Detailed description
Study duration per participant is approximately 90 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Quadrivalent RIV with H3 strain 1 | Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular |
| BIOLOGICAL | Quadrivalent RIV with H3 strain 2 | Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular |
| BIOLOGICAL | Quadrivalent RIV with H3 strain 3 | Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular |
| BIOLOGICAL | Quadrivalent RIV with H3 strain 4 | Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular |
| BIOLOGICAL | Quadrivalent RIV with 2018-2019 NH H3 strain | Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular |
Timeline
- Start date
- 2019-11-06
- Primary completion
- 2020-02-24
- Completion
- 2020-02-24
- First posted
- 2019-10-30
- Last updated
- 2025-07-29
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04144179. Inclusion in this directory is not an endorsement.