Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines

Summary

The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine.

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334).

Conditions

• Hepatitis B
• Acellular Pertussis
• Tetanus
• Poliomyelitis
• Diphtheria
• Streptococcus Pneumoniae Vaccines

Interventions

BIOLOGICAL

Pneumococcal conjugate vaccine GSK1024850A

Intramuscular injection, 1 dose.

BIOLOGICAL

Prevenar

Intramuscular injection, 1 dose.

BIOLOGICAL

Infanrix hexa

Intramuscular injection, 1 dose. In Germany and Poland.

BIOLOGICAL

Infanrix IPV Hib

Intramuscular injection, 1 dose. In Spain.

BIOLOGICAL

Infanrix penta

Intramuscular injection, 1 dose. In Germany and Poland.

BIOLOGICAL

Infanrix IPV

Intramuscular injection, 1 dose. In Spain.

BIOLOGICAL

Meningitec

Intramuscular injection, 1 dose.

BIOLOGICAL

NeisVac-C

Intramuscular injection, 1 dose.

BIOLOGICAL

Menitorix

Intramuscular injection, 1 dose.

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

11 Months

Max Age

18 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-04-25

Primary Completion

2008-01-21

Completion

2008-06-14

Countries

• Germany
• Poland
• Spain

Study Locations