At a glance
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Impact on Nasopharyngeal Carriage, Acute Otitis Media, Immunogenicity and Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
In Brief
A Phase 3 clinical trial evaluating Pneumococcal conjugate vaccine Synflorix (GSK1024850A), GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine), and 1 other intervention for Infections, Streptococcal and Streptococcus Pneumoniae. Completed, enrolled 6,181 participants across 15 sites.
Detailed 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.
Study Details
Timeline
Interventions
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children \< 12 months of age at the time of first study vaccination.
2 Intramuscular injections only for children \>= 12 months of age at the time of first study vaccination.