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Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants

Infections, Streptococcal Clinical Trial

Official title:
Study to Assess the Safety and Immunogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine When Co-administered With DTPa-HBV-IPV/Hib (Infanrix-Hexa) Vaccine in Preterm Infants as a 3-dose Primary Immunization Course During the First 6 Months of Life.

Clinical Trial Summary

This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life.

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 = 00609492)

Clinical Trial Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00390910
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date October 1, 2006
Completion date May 2, 2008
View Details
See also
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