Trials / Completed
CompletedNCT03814590
A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults
Phase I/II, Observer-blind, Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Respiratory Syncytial Virus (RSV) Vaccine GSK3844766A in Subjects Aged 18-40 or 60-80 Years
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 1,053 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the safety, reactogenicity and immune responses of two doses of the investigational RSV vaccines (with different formulations), when administered intramuscularly (IM) according to a 0, 2 month schedule, in older adults aged 60 to 80 years. As the investigational vaccines have not yet been tested in humans before, the study will first assess the safety, reactogenicity and immune responses in young adults aged 18 to 40 years. The study will thus be conducted in 2 parts (Part A and Part B).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSV Vaccine (GSK3844766A) unadjuvanted low dose | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm |
| BIOLOGICAL | RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| BIOLOGICAL | RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm |
| BIOLOGICAL | RSV Vaccine (GSK3844766A) unadjuvanted medium dose | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| BIOLOGICAL | RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| BIOLOGICAL | RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| BIOLOGICAL | RSV Vaccine (GSK3844766A) unadjuvanted high dose | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| BIOLOGICAL | RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm |
| BIOLOGICAL | RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| DRUG | Placebo (Saline solution) | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
Timeline
- Start date
- 2019-01-21
- Primary completion
- 2019-12-12
- Completion
- 2020-11-30
- First posted
- 2019-01-24
- Last updated
- 2022-08-05
- Results posted
- 2022-03-23
Locations
21 sites across 2 countries: United States, Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03814590. Inclusion in this directory is not an endorsement.