Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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 and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
This protocol posting deals with objectives & outcome measures of the extension phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).
Full description
This protocol posting has been updated according to Protocol Amendment 1, July 2009
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
466 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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