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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 8, 2005
Last updated: May 24, 2017
Last verified: May 2017
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
Intervention Model: Parallel Assignment
Masking: None (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.

Secondary Outcome Measures:
  • - 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.

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.

Ages Eligible for Study:   3 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00158795

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

Responsible Party: GlaxoSmithKline Identifier: NCT00158795     History of Changes
Other Study ID Numbers: 104124
Study First Received: September 8, 2005
Last Updated: May 24, 2017

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017