Booster and catch-up vaccination with vaccine GSK1024850A

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 282

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of immune responses to components of the investigational vaccine in primed subjectsTimepoint: One month after booster vaccination

Secondary Outcome Measures

Name	Time	Method
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

Related Trials