Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Infections, Streptococcal

Treatments

Biological: Pneumococcal (vaccine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00334334

107005

Details and patient eligibility

About

Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae type b.

Enrollment

1,572 patients

Sex

All

Ages

6 to 16 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

male or female between, and including, 6-16 weeks (42 to 118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.

Exclusion criteria

use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
Previous vaccinations against diseases which are targeted by the vaccines used in the study.