Status:
COMPLETED
Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Streptococcus Pneumoniae
Eligibility:
All Genders
46-50 years
Phase:
PHASE3
Brief Summary
The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in ...
Eligibility Criteria
Inclusion
- Male or female between, and including, 46-50 months of age at the time of vaccination.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™.
- Written informed consent obtained from both parents/guardians of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period.
- Administration of any pneumococcal vaccine since the end of study NCT00333450.
- Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical
- History of any neurologic disorders or seizures
- Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- History of hypotonic-hyporesponsive episode after any previous vaccination.
- Major congenital defects or serious chronic illness.
- History of invasive pneumococcal diseases.
- Acute disease at the time of vaccination
- Rectal temperature \>= 38.0°C or oral/axillary/tympanic temperature \>= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
Key Trial Info
Start Date :
June 23 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00907777
Start Date
June 23 2009
End Date
October 5 2009
Last Update
November 23 2020
Active Locations (17)
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1
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany, 68163
2
GSK Investigational Site
Nördlingen, Bavaria, Germany, 86720
3
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32549
4
GSK Investigational Site
Goch, North Rhine-Westphalia, Germany, 47574