Status:
COMPLETED
Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
36-46 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the immune memory induced by primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through evaluation of the ...
Eligibility Criteria
Inclusion
- Male or female between, and including, +- 36-46 months of age at the time of vaccination.
- For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034).
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/guardian(s) of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination.
- For primed subjects: administration of any pneumococcal vaccine since the end of the primary study (NCT00307034).
- For unprimed subjects: previous vaccination with any pneumococcal vaccine.
- Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine.
- Acute disease at the time of enrolment.
Key Trial Info
Start Date :
December 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2009
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00792909
Start Date
December 2 2008
End Date
July 2 2009
Last Update
December 14 2017
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Dlhá nad Oravou, Slovakia, 027 55
2
GSK Investigational Site
Dolný Kubín, Slovakia, 026 01
3
GSK Investigational Site
Ružomberok, Slovakia, 034 01
4
GSK Investigational Site
Örebro, Sweden, SE-701 16