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Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age

NCT00808444 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 466

Last updated 2018-08-17

Study results available
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Summary

The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

Pneumococcal conjugate vaccine GSK1024850A (different lots)

Intramuscular injection, 3 doses

BIOLOGICAL

Infanrix hexa

Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore

BIOLOGICAL

Infanrix-IPV/Hib

Intramuscular injection, only for Visit 2 in Singapore

BIOLOGICAL

Rotarix

Oral, 2 doses

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
2009-01-05
Primary Completion
2009-11-02
Completion
2009-11-02

Countries

  • Malaysia
  • Singapore

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 NCT00808444 on ClinicalTrials.gov