None listed
Conditions
Interventions
Intervention1: Pneumococcal vaccine GSK1024850A: Intramuscular injection, administered as a single dose
Intervention2: Pneumococcal vaccine GSK1024850A: Intramuscular injection, 3 doses
Control Interv
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of immune responses to components of the investigational vaccine in primed subjectsTimepoint: One month after booster vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of immune responses to components of the investigational vaccine in primed subjectsTimepoint: Prior to booster vaccination, one month after booster vaccination and at approximately 24 months of age;Evaluation of immune responses to components of the investigational vaccine in unprimed subjectsTimepoint: Prior to vaccination, one month post-dose 2, prior to and one month after the third (booster) vaccine dose;Occurrence of each solicited adverse eventTimepoint: Within 4 days after each vaccination;Occurrence of serious adverse eventsTimepoint: After the first vaccination up to 31 days after the last vaccination.;Occurrence of unsolicited adverse eventsTimepoint: Within 31 days after each vaccination | — |
Countries
India
Contacts
Public ContactDr Shailesh Mehta
GlaxoSmithKline
Outcome results
None listed