Booster and Catch-up Vaccination With Vaccine GSK1024850A
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18 months of age in children primed in primary study NCT00814710.
This study also aims to assess the persistence of antibodies induced following primary vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to booster vaccination and following vaccination in the present study at approximately 24 months of age.
The study is also designed to evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.
Full description
The study is randomized for primed subjects and non-randomized for unprimed subjects.
The protocol posting has been updated according to the amendment of the protocol dated 16 April 2010. The age range at the time of randomization of subjects primed in study NCT00814710 and the age range for booster vaccination of one of the groups has been extended.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Male or female subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
- Written, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
For primed subjects:
- Completion of the full vaccination course in study NCT00814710.
- 9-18 months of age at the time of randomization.
- Group A: 9-18 months of age at the time of booster vaccination.
- Group B: 15-18 months of age at the time of booster vaccination.
For unprimed subjects (Group C):
- Enrolled in study NCT00814710.
- 12-18 months of age at the time of first vaccination.
Exclusion criteria
- Use of any investigational or non-registered product within 30 days preceding the vaccination, or planned use during the study period.
- 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
- Administration of any pneumococcal vaccine since the end of study NCT00814710.
- 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 vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
Trial design
Primary purpose
Allocation
Interventional model
Masking
282 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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