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

GlaxoSmithKline454 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

454

Conditions

Haemophilus Influenzae Type b Disease

Interventions

Haemophilus Influenza type b vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 4 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Nanning, Guangxi, China

Outcomes

Primary Outcomes

Occurrence of solicited symptoms of grade 3 intensity, during the specific follow-up period after vaccination.

Secondary Outcomes

- Occurrence of solicited symptoms during the specific follow up period after vaccination.

- Occurrence of unsolicited symptoms during the specific follow up period after vaccination.

- Occurrence of serious adverse events during the study period.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.