Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants

Summary

This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.

Conditions

• Infections, Streptococcal

Interventions

BIOLOGICAL

Pneumococcal vaccine GSK 2189242A (LD formulation 1)

Intramuscular injection

BIOLOGICAL

Pneumococcal vaccine GSK 2189242A (HD formulation 2)

Intramuscular injection

BIOLOGICAL

Synflorix™

Intramuscular injection

BIOLOGICAL

Prevnar13™

Intramuscular injection

BIOLOGICAL

Tritanrix™-HepB/Hib

Intramuscular injection

BIOLOGICAL

Polio Sabin™

Orally

BIOLOGICAL

M-Vac™

Intramuscular injection

BIOLOGICAL

Stamaril™

Intramuscular injection

Sponsors & Collaborators

• PATH

  collaborator OTHER

• Department of State for Health and Social Welfare, The Gambia

  collaborator OTHER_GOV

• Medical Research Council Unit, The Gambia

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

56 Days

Max Age

4 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-02-09

Primary Completion

2013-03-18

Completion

2013-03-18

Countries

• The Gambia

Study Locations