Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV
Public ClinicalTrials.gov record NCT03636906. 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
A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Infants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to provide critical information on the safety, reactogenicity and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type 155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV and will assess a single lower dose and a higher two dose regimen, before moving to future studies. This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease' after vaccination of these infants with the ChAd155-RSV vaccine.
Study identification
- NCT ID
- NCT03636906
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 201 participants
Conditions and interventions
Conditions
Interventions
- RSV (GSK3389245A) lower dose formulation vaccine Biological
- RSV (GSK3389245A) higher dose formulation vaccine Biological
- GSK's multicomponent meningococcal B vaccine Biological
- Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine Biological
- GSK's pneumococcal polysaccharide conjugate vaccine Biological
- GSK's meningococcal group A, C, W-135 and Y conjugate vaccine Biological
- Placebo Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 6 Months to 7 Months
- 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
- Apr 8, 2019 (Actual)
- Primary completion
- Jan 16, 2020 (Actual)
- Completion
- Jul 22, 2021 (Actual)
- Last update posted
- Jul 27, 2022
2019 – 2021
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Atlanta | Georgia | 30322 | — |
| GSK Investigational Site | Nampa | Idaho | 83686 | — |
| GSK Investigational Site | Louisville | Kentucky | 40243 | — |
| GSK Investigational Site | Baltimore | Maryland | 21201 | — |
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 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03636906, 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 Jul 27, 2022 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03636906 live on ClinicalTrials.gov.