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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00158795
First received: September 8, 2005
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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)


Condition Intervention Phase
Haemophilus Influenzae Type b Disease
Biological: Haemophilus Influenza type b vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of solicited symptoms of grade 3 intensity, during the specific follow-up period after vaccination. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Occurrence of solicited symptoms during the specific follow up period after vaccination. [ Designated as safety issue: No ]
  • - Occurrence of unsolicited symptoms during the specific follow up period after vaccination. [ Designated as safety issue: No ]
  • - Occurrence of serious adverse events during the study period. [ Designated as safety issue: No ]

Enrollment: 454
Study Start Date: January 2005
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   3 Months to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158795

Locations
China, Guangxi
GSK Investigational Site
Nanning, Guangxi, China, 530021
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00158795     History of Changes
Other Study ID Numbers: 104124
Study First Received: September 8, 2005
Last Updated: September 29, 2011
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on October 19, 2014