Trials / Completed
CompletedNCT04657198
Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study
A Phase 2b, Open-label, Multi-center, Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 Older Adults (OA) Investigational Vaccine Administered Intramuscularly 18 Months Post-Dose 2 in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 126 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
Summary
Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Participants in selected groups will be invited to participate in this extension study. All participants who will be enrolled in the current extension study will receive the RSV investigational vaccine approximately 18 months after they received their respective dose-2 in the parent study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSVPreF3 OA investigational vaccine (GSK3844766A) | RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study). |
Timeline
- Start date
- 2020-12-09
- Primary completion
- 2021-06-03
- Completion
- 2021-10-25
- First posted
- 2020-12-08
- Last updated
- 2022-06-29
- Results posted
- 2022-06-29
Locations
10 sites across 2 countries: United States, Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04657198. Inclusion in this directory is not an endorsement.