Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Streptococcus Pneumoniae

Infections, Streptococcal

Treatments

Biological: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)

Biological: Pneumococcal conjugate vaccine GSK 1024850A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00907777

2008-007605-37 (EudraCT Number)

112807

Details and patient eligibility

About

The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.

Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™.

This protocol posting deals with objectives & outcome measures of the extension phase at year 4. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).

Enrollment

52 patients

Sex

All

Ages

46 to 50 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female between, and including, 46-50 months of age at the time of vaccination.
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™.
Written informed consent obtained from both parents/guardians of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period.
Administration of any pneumococcal vaccine since the end of study NCT00333450.
Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical
History of any neurologic disorders or seizures
Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
History of hypotonic-hyporesponsive episode after any previous vaccination.
Major congenital defects or serious chronic illness.
History of invasive pneumococcal diseases.
Acute disease at the time of vaccination
Rectal temperature >= 38.0°C or oral/axillary/tympanic temperature >= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.