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Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A

Infections, Streptococcal Clinical Trial

Official title:
Impact on Nasopharyngeal Carriage, Acute Otitis Media, Immunogenicity and Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A

Clinical Trial Summary

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H. influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions in children starting vaccination below 18 months of age. These data will be collected from the national registers and will be analyzed in combination with data collected for subjects enrolled in a large scale cluster-randomized study 111442. The study will also assess the immune response to the GSK1024850A vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.

Clinical Trial Description

The protocol posting has been updated with regards to the outcome measures following Protocol amendment 4, 12 August 2011. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00839254
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date February 18, 2009
Completion date January 31, 2012
View Details
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