A phase IIIa open, randomised, controlled study to assess the safety, reactogenicity and immunogenicity induced by a booster dose of GlaxoSmithKline (GSK) Biologicals 10-valent pneumococcal conjugate vaccine when co-administered with GSK Biologicals’ measles-mumps-rubella-varicella vaccine (MMRV) vaccine in children during their second year of life, previously vaccinated in infancy in the primary study 10PN-PD-DIT-001 (105553) with GSK Biologicals 10-valent pneumococcal conjugate vaccine. - 10PN-PD-DIT-022 BST: 001

GlaxoSmithKline Biologicals0 sites400 target enrollmentJune 16, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Booster vaccination against Streptococcus pneumoniae and active immunization against measles, mumps, rubella and varicella diseases in children during the second year of life.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 400
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

June 16, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Male or female between, and including, ± 12\-14 months of age at the time of first vaccination.
•Subjects who previously participated in the study 10PN\-PD\-DIT\-001 and received at least one dose of 10\-valent pneumococcal conjugate vaccine during the primary study.
•Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow\-up visit).
•Written informed consent obtained from the parent or guardian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine(s), or planned use during the entire study period (active phase and extended safety follow\-up).
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, \= 0\.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and ending 42\-56 days after the last dose of vaccine(s).
•Administration of any additional pneumococcal vaccine since end of 10PN\-PD\-DIT\-001 study.
•Previous vaccination against measles, mumps, rubella and/or varicella.
•History of or intercurrent measles, mumps, rubella and/or varicella/zoster diseases.
•Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to study start.
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.