A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Infections, Streptococcal

Treatments

Biological: Pneumococcal (vaccine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00307554

105553

Details and patient eligibility

About

Evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals' 10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar.

Full description

Test groups: 4 (400 subjects/group). 3 groups receiving 10-valent pneumococcal conjugate vaccine (3 different lots) as follows: - 10-valent vaccine (lot 1, 2 or 3) + DTPa combined vaccine; Control group receiving Prevenar + DTPa combined vaccine

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female between, and including, 6 and 12 weeks (42-90 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 preceeding the first dose of study vaccine, or planned use during the study period.
Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.