Assess Safety & Reactogenicity of GSK Biologicals' Hib Vaccine Co-administered With or Without Chinese DTPw Vaccine

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Haemophilus Influenzae Type b Disease

Treatments

Biological: Haemophilus Influenza type b vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00158795

104124

Details and patient eligibility

About

To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants (3, 4 and 5 months of age)

Full description

All subjects will be randomized into two groups. One group will receive DTPw vaccine co-administered with Hib and another group will receive DTPw vaccine alone. A specific follow-up of solicited local and general symptoms after each vaccination. A specific follow-up of unsolicited symptoms after each vaccination. Recording of serious adverse events reported during the study period.

Enrollment

454 patients

Sex

All

Ages

3 to 4 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.

Exclusion criteria

Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
Chronic administration of immunosuppressants or other immune-modifying drugs from birth until administration of first dose of study vaccine.
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use during the study period.