Trials / Completed
CompletedNCT05648357
A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India
A Single-arm, Open-label, Multi-center, Phase IV Trial to Evaluate the Reactogenicity, Safety, and Immunogenicity of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter \[mL\]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Fluarix Tetra Vaccine | A single dose of Fluarix Tetra vaccine administered intramuscularly (IM) on day 1. |
Timeline
- Start date
- 2023-12-14
- Primary completion
- 2024-02-26
- Completion
- 2024-02-26
- First posted
- 2022-12-13
- Last updated
- 2025-03-28
- Results posted
- 2025-03-28
Locations
6 sites across 1 country: India
Source: ClinicalTrials.gov record NCT05648357. Inclusion in this directory is not an endorsement.