Trials / Completed
CompletedNCT04789577
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine GSK3206641A Administered in Adults 18 to 64 Years of Age and 65 Years of Age and Older
A Phase I/II Observer-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Hong Kong/125/2017-like (H7N9) Virus Vaccine With AS03 Adjuvant System, Given as a Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 833 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Study to evaluate the safety and immunogenicity of H7N9 antigen in combination with full or half doses of AS03 adjuvant system in healthy adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | FLU-Q-PAN H7N9 Formulation 1 | Participants received two doses of the FLU-Q-PAN H7N9 Formulation 1 vaccine by intramuscular injection in the non-dominant arm. |
| BIOLOGICAL | FLU-Q-PAN H7N9 Formulation 2 | Participants received two doses of the FLU-Q-PAN H7N9 Formulation 2 vaccine by intramuscular injection in the non-dominant arm. |
| BIOLOGICAL | FLU-Q-PAN H7N9 Formulation 3 | Participants received two doses of the FLU-Q-PAN H7N9 Formulation 3 vaccine by intramuscular injection in the non-dominant arm. |
| BIOLOGICAL | AS03B | Participants received two doses of the AS03B adjuvant by intramuscular injection in the non-dominant arm. |
| BIOLOGICAL | AS03A | Participants received two doses of the AS03A adjuvant by intramuscular injection in the non-dominant arm. |
| DRUG | Placebo | Participants received two doses of Placebo by intramuscular injection in the non-dominant arm. |
Timeline
- Start date
- 2021-03-16
- Primary completion
- 2022-09-12
- Completion
- 2022-09-12
- First posted
- 2021-03-09
- Last updated
- 2023-10-10
- Results posted
- 2023-10-10
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04789577. Inclusion in this directory is not an endorsement.