A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults
Public ClinicalTrials.gov record NCT03814590. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03814590
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 1,053 participants
Conditions and interventions
Conditions
Interventions
- RSV Vaccine (GSK3844766A) unadjuvanted low dose Biological
- RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E Biological
- RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B Biological
- RSV Vaccine (GSK3844766A) unadjuvanted medium dose Biological
- RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E Biological
- RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B Biological
- RSV Vaccine (GSK3844766A) unadjuvanted high dose Biological
- RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E Biological
- RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B Biological
- Placebo (Saline solution) Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 20, 2019
- Primary completion
- Dec 11, 2019
- Completion
- Nov 29, 2020
- Last update posted
- Aug 4, 2022
2019 – 2020
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Jacksonville | Florida | 32216 | — |
| GSK Investigational Site | Miami | Florida | 33143 | — |
| GSK Investigational Site | Stockbridge | Georgia | 30281 | — |
| GSK Investigational Site | Lenexa | Kansas | 66219 | — |
| GSK Investigational Site | Wichita | Kansas | 67207 | — |
| GSK Investigational Site | Elkridge | Maryland | 21075 | — |
| GSK Investigational Site | Kansas City | Missouri | 64114 | — |
| GSK Investigational Site | Omaha | Nebraska | 68134 | — |
| GSK Investigational Site | Rochester | New York | 14609 | — |
| GSK Investigational Site | Hickory | North Carolina | 28602 | — |
| GSK Investigational Site | Wilmington | North Carolina | 28401 | — |
| GSK Investigational Site | Cleveland | Ohio | 44122 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | — |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | — |
| GSK Investigational Site | Fort Worth | Texas | 76135 | — |
| GSK Investigational Site | Houston | Texas | 77081 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03814590, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2022 · Synced Sep 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03814590 live on ClinicalTrials.gov.