Status:
COMPLETED
Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Streptococcus Pneumoniae Vaccines
Eligibility:
All Genders
28-32 years
Phase:
PHASE3
Brief Summary
This protocol posting deals with objectives \& outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 4...
Detailed Description
This study consists in a serological follow-up study to evaluate persistence 12, 24 and 48 months after the booster vaccination study (107046). No study vaccines will be administered within this study...
Eligibility Criteria
Inclusion
- Male or female between, and including, 28-30 months of age at the time of first blood sampling.
- Subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Written informed consent, covering visits 1, 2 and 3, obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling
- Administration of any additional pneumococcal vaccine since end of 107046 study.
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
- Administration of immunoglobulins and/or any blood products less than 6 months prior to blood sampling.
- Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 107046 study, based on medical history and physical examination.
Key Trial Info
Start Date :
March 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2008
Estimated Enrollment :
524 Patients enrolled
Trial Details
Trial ID
NCT00624819
Start Date
March 3 2008
End Date
June 2 2008
Last Update
January 27 2021
Active Locations (6)
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1
GSK Investigational Site
Bydgoszcz, Poland, 85-021
2
GSK Investigational Site
Dębica, Poland, 39-200
3
GSK Investigational Site
Krakow, Poland, 31-503
4
GSK Investigational Site
Oleśnica, Poland, 56-400