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NCT03636906 · ClinicalTrials.gov registry record · Phase 1
Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 201
- Enrollment target
NCT03636906 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 201 participants.
The verdict
NCT03636906, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 201 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2019-04-08 |
| Est. Completion | 2021-07-22 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03636906
The ClinicalTrials.gov registry entry for NCT03636906 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which RSV (GSK3389245A) lower dose formulation vaccine is the first listed.
NCT03636906 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03636906 about?
NCT03636906 is a clinical study titled "Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV". 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 ...
What is the current status of trial NCT03636906?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 201 participants. The study started on 2019-04-08. Estimated completion is 2021-07-22.
What interventions are being tested in trial NCT03636906?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT03636906?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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