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
Public ClinicalTrials.gov record NCT04657198. 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.
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Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04657198
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 126 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 60 Years and older
- 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
- Dec 9, 2020 (Actual)
- Primary completion
- Jun 3, 2021 (Actual)
- Completion
- Oct 25, 2021 (Actual)
- Last update posted
- Jun 29, 2022
2020 – 2021
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Lenexa | Kansas | 66219 | — |
| GSK Investigational Site | Elkridge | Maryland | 21075 | — |
| GSK Investigational Site | Omaha | Nebraska | 68134 | — |
| GSK Investigational Site | Rochester | New York | 14609 | — |
| GSK Investigational Site | Hickory | North Carolina | 28601 | — |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | — |
| 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 NCT04657198, 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 Jun 29, 2022 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04657198 live on ClinicalTrials.gov.