A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Streptococcal Infections

Treatments

Biological: Pneumococcal (vaccine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00169481

103488

Details and patient eligibility

About

Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.

Full description

Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa

Enrollment

689 patients

Sex

All

Ages

8 to 16 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of 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 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.