Status:
COMPLETED
Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
31-44 years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence a...
Detailed Description
This protocol posting has been updated according to Protocol Amendment 1, July 2009
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 31 and 34 months of age at the time of the enrolment.
- Subjects who previously participated in study NCT00496015
- For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the study amendment 3.
- For the subjects in the unprimed group: subjects who received a dose of the meningococcal vaccine GSK134612.
- Written informed consent 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
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of seizures or progressive neurological disease.
- Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
- Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
- Administration of any pneumococcal vaccine since the end of study NCT00496015.
Key Trial Info
Start Date :
August 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2010
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT00950833
Start Date
August 10 2009
End Date
October 27 2010
Last Update
September 20 2018
Active Locations (10)
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1
GSK Investigational Site
Brno, Czechia, 628 00
2
GSK Investigational Site
Hradec Králové, Czechia, 500 01
3
GSK Investigational Site
Jindřichův Hradec, Czechia, 377 01
4
GSK Investigational Site
Náchod, Czechia, 547 01