Status:
COMPLETED
Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
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) in preventing invasive disease caused by S. pneumoniae or H. influenzae and in red...
Detailed Description
The protocol posting has been updated with regards to the outcome measures following Protocol amendment 4, 12 August 2011.
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- 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
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use of such a vaccine(s) other than the study vaccine(s) during the entire study period.
- Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine, or planned use of such a vaccine other than the study vaccine during the study period. If a child belongs to a high risk group for pneumococcal infections (such as children with an anatomic or functional asplenia, HIV infection, chronic cardiac or respiratory disease (not asthma), diabetes, cochlear implant, CSF fistula or with significant immunodeficiency) 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 :
February 18 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2012
Estimated Enrollment :
6181 Patients enrolled
Trial Details
Trial ID
NCT00839254
Start Date
February 18 2009
End Date
January 31 2012
Last Update
December 17 2020
Active Locations (15)
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1
GSK Investigational Site
Espoo, Finland, 02100
2
GSK Investigational Site
Helsinki, Finland, 00100
3
GSK Investigational Site
Helsinki, Finland, 00930
4
GSK Investigational Site
Jarvenpaa, Finland, 04400