Booster and Catch-up Vaccination With Vaccine GSK1024850A

Condition(s) targeted: Pneumococcal Disease

Intervention: Pneumococcal vaccine GSK1024850A (Biological); Pneumococcal vaccine GSK1024850A (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of pneumococcal vaccine GSK1024850A administered either at 9-12 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.

Official title: Booster Vaccination With Pneumococcal Vaccine GSK1024850A in Primed Children and Catch-up Vaccination in Unprimed Children

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Evaluation of immune responses to components of the investigational vaccine in primed subjects

Secondary outcome:

Evaluation of immune responses to components of the investigational vaccine in primed subjects

Evaluation of immune responses to components of the investigational vaccine in unprimed subjects

Occurrence of each solicited adverse event

Occurrence of unsolicited adverse events

Occurrence of serious adverse events

Detailed description: The study is randomized for primed subjects and non-randomized for unprimed subjects.

Minimum age: 9 Months. Maximum age: 18 Months. Gender(s): Both.

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.

- 9-12 months of age at the time of randomization.

- Group A: 9-12 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.

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, Kolkata 700073, India; Recruiting
Sukanta Chatterjee, Principal Investigator

GSK Investigational Site, Ludhiana 141 008, India; Recruiting
Jugesh Chhatwal, Principal Investigator

GSK Investigational Site, Pune, India; Recruiting
Sanjay Lalwani, Principal Investigator

GSK Investigational Site, Vellore 632004, India; Recruiting
Valsan P Verghese, Principal Investigator

Starting date: April 2010
Last updated: April 22, 2010