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Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib

NCT00652951 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2019-06-26

Study results available
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Summary

The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)

Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination

BIOLOGICAL

Infanrix™ hexa.

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

BIOLOGICAL

Pediacel™

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

BIOLOGICAL

Prevenar™

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-04-01
Primary Completion
2009-05-12
Completion
2010-12-01

Countries

  • Netherlands

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 NCT00652951 on ClinicalTrials.gov