CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 201 enrolled
Drug / intervention
RSV (GSK3389245A) lower dose formulation vaccine +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03636906
NCT03636906Phase 2Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Aug 17, 2018·Updated Jul 27, 2022

In Brief

A Phase 2 clinical trial evaluating RSV (GSK3389245A) lower dose formulation vaccine, RSV (GSK3389245A) higher dose formulation vaccine, and 5 other interventions for Respiratory Syncytial Virus Infections. Completed, enrolled 201 participants across 37 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesBrazil, Canada, Colombia, Finland, Italy, Mexico, Panama, Poland, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 17, 2018
Enrollment StartApr 8, 2019
Primary CompletionJan 16, 2020
Study CompletionJul 22, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.9 years ago

Interventions

RSV (GSK3389245A) lower dose formulation vaccinebiological

1 dose of RSV (GSK3389245A) lower dose formulation vaccine administered intramuscularly at Day 1.

RSV (GSK3389245A) higher dose formulation vaccinebiological

2 doses of RSV (GSK3389245A) higher dose formulation vaccine administered intramuscularly, at Day 1 and Day 31.

GSK's multicomponent meningococcal B vaccinebiological

3 doses of GSK's multicomponent meningococcal B vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccinebiological

3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

GSK's pneumococcal polysaccharide conjugate vaccinebiological

3 doses of GSK's pneumococcal polysaccharide conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 31, Day 61 and end of RSV season 1, depending on the vaccination schedule.

GSK's meningococcal group A, C, W-135 and Y conjugate vaccinebiological

2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61 and at the end of RSV season 1, or at Day 31 and end of RSV season 1, depending on the vaccination schedule.

Placebodrug

1 dose or 2 doses of Placebo administered intramuscularly at Day 31, or at Day 1 and Day 31, or at Day 1 and Day 61, or at Day 31 and Day 121, depending on the vaccination schedule.