Status:
COMPLETED
Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Streptococcus Pneumoniae
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief 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 disea...
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.
Eligibility Criteria
Inclusion
- Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination.
- Written informed consent obtained from parent(s) or from the guardian(s) of the subject.
Exclusion
- Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine other than the study vaccine, or planned use during the study period. If a child belongs to a high risk group for pneumococcal infections for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program.
- Previous vaccination against Hepatitis B virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
- Previous vaccination against Hepatitis A virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
- Known severe hypersensitivity to any component of the study vaccines, including neomycin.
- Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
Key Trial Info
Start Date :
May 4 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2013
Estimated Enrollment :
41188 Patients enrolled
Trial Details
Trial ID
NCT00861380
Start Date
May 4 2009
End Date
October 5 2013
Last Update
December 17 2020
Active Locations (1)
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1
GSK Investigational Site
Helsinki, Finland, 00270