NCT00861380

Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41,188 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 18 Months
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), administered according to different vaccination schedules, against invasive disease caused by S. pneumoniae or H. influenzae as well as vaccine impact on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions. This study will also explore vaccine impact on occurrence of respiratory tract infections (RTIs), including acute otitis media (AOM) in a subset of children in Turku area.

Detailed description

The protocol posting has been updated with regards to the enrolment of subjects and outcome measures following Protocol amendment 2, 22 August 2011.

Conditions

• Infections, Streptococcal
• Streptococcus Pneumoniae

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal conjugate vaccine GSK1024850A	2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
BIOLOGICAL	GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)	3 or 4 Intramuscular injections, depending on the age at the time of first vaccination. Control 3+1 and Control 2+1 groups, only for children \< 12 months of age at the time of first study vaccination.
BIOLOGICAL	GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)	2 Intramuscular injections. Control 3+1 and Control 2+1 groups, only for children \>= 12 months of age at the time of first study vaccination.

Timeline

• Start date: 2009-05-04
• Primary completion: 2012-01-31
• Completion: 2013-10-05
• First posted: 2009-03-13
• Last updated: 2020-12-17
• Results posted: 2020-09-25

Locations

1 site across 1 country: Finland