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Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV

NCT03636906 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2022-07-27

Study results available
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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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSV (GSK3389245A) lower dose formulation vaccine

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

BIOLOGICAL

RSV (GSK3389245A) higher dose formulation vaccine

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

BIOLOGICAL

GSK's multicomponent meningococcal B vaccine

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.

BIOLOGICAL

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

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.

BIOLOGICAL

GSK's pneumococcal polysaccharide conjugate vaccine

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.

BIOLOGICAL

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

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.

DRUG

Placebo

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-08
Primary Completion
2020-01-16
Completion
2021-07-22
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Colombia
  • Finland
  • Italy
  • Mexico
  • Panama
  • Poland
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03636906 on ClinicalTrials.gov