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

Assess the Safety & Reactogenicity of GSK Biologicals Hib Vaccine Co-administered With Chinese Local DTPw Vaccine When Compared to Chinese Local DTPw Vaccine Administered Alone, in Healthy Infants at 3,4 & 5 Mths of Age

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)

Study Overview

• Status: Completed
• Conditions: Haemophilus Influenzae Type b Disease
• Intervention / Treatment: Biological: Haemophilus Influenza type b vaccine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 454
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 4 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
- 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.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (ACTUAL): July 1, 2005
• Study Completion (ACTUAL): July 1, 2005

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (ESTIMATE): September 12, 2005

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 104124