Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT03636906 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 201 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (235% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed solicited local AEs are erythema, pain and swelling at injection site. Any = occurrence of the adverse event regardless of intensity grade. Any redness and swelling = adverse event reported with a surface diameter greater than 0 millimeters. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, active comparators pooled and placebo groups separately to compare the expected adverse events observed from routine pediatric vaccines (active comparators) with the
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 |
What the finished NCT03636906 record still lists
NCT03636906 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (235% higher).
The record links to 0 conditions, and to 5 interventions - of which RSV (GSK3389245A) lower dose formulation vaccine is the first listed.
NCT03636906 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03636906's enrollment target sits among peer trials
201 258th of 2000 higher than 1,742 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04422652 · 201 participants · Phase 2
Combination of Novel Therapies for CKD Comorbid Depression
- NCT05327114 · 201 participants · Phase 2
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- NCT06099769 · 201 participants · Phase 2
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
- NCT06274528 · 201 participants · Phase 2
DORA and LP in Alzheimer's Disease Biomarkers
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI