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Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants

NCT00871338 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2018-06-06

Study results available
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Summary

The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.

Conditions

  • Neisseria Meningitidis
  • Haemophilus Influenzae Type b

Interventions

BIOLOGICAL

GSK2197870A

3 doses given at 2, 3 and 4 months of age

BIOLOGICAL

Prevenar™

3 co-administered doses, intramuscular into right thigh

BIOLOGICAL

Menitorix™

1 booster dose at 12 months of age

BIOLOGICAL

Pediacel™

3 doses given at 2, 3 and 4 months of age

BIOLOGICAL

Menjugate™

2 doses given at 3 and 4 months of age

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-24
Primary Completion
2010-03-31
Completion
2010-12-09

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT00871338 on ClinicalTrials.gov