Trials / Completed
CompletedNCT03497845
Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59
Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Homologous and Heterologous Prime-Boost Vaccination Strategies With Stockpiled Inactivated Monovalent Influenza A(H5) Vaccines Administered Intramuscularly With Either AS03 or MF59® as Adjuvant
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 720 (actual)
- Sponsor
- Biomedical Advanced Research and Development Authority · Federal
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains. The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VN | 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose |
| BIOLOGICAL | IN | 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose |
| BIOLOGICAL | dk/BANG | 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose |
| BIOLOGICAL | gf/WA | 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose |
| BIOLOGICAL | bhg/QL | 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose |
| BIOLOGICAL | AS03 adjuvant | 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose |
| BIOLOGICAL | MF59 adjuvant | 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose |
Timeline
- Start date
- 2018-03-15
- Primary completion
- 2019-11-19
- Completion
- 2019-11-19
- First posted
- 2018-04-13
- Last updated
- 2020-07-14
- Results posted
- 2020-07-14
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03497845. Inclusion in this directory is not an endorsement.