MedTrace Logo

Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

NCT00344318 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2018-12-07

Study results available
· View outcomes & findings →

Summary

This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age.

The study has 2 groups.

* One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated).
* The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.

All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol posting deals with objectives \& outcome measures of the primary study. The objectives \& outcome measures of the Booster study are presented in a separate protocol posting (NCT number =00547248).

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

Pneumococcal conjugate vaccine GSK1024850A

3 Intramuscular injections.

BIOLOGICAL

Prevenar

3 Intramuscular injections

BIOLOGICAL

Tritanrix-HepB

3 Intramuscular injections

BIOLOGICAL

Hiberix

Reconstituted with Tritanrix before injection

BIOLOGICAL

Polio Sabin.

3 oral doses.

BIOLOGICAL

Poliorix.

3 intramuscular injections

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-08-07
Primary Completion
2007-04-27
Completion
2007-10-17

Countries

  • Philippines
  • Poland

Study Locations

More Related Trials

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 NCT00344318 on ClinicalTrials.gov