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

Phase 4

Completed

• Conditions: Haemophilus Influenzae Type b Disease

• Registration Number: NCT00158795
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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)

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 Timeline

• Study Start: 2005-01
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 454

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
- 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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Nanning, Guangxi, China