Clinical Trial: To Assess Safety and Reactogenicity of GSK Biologicals'' Haemophilus Influenza Type b Vaccine Co-Administered with or Without Chinese DTPw Vaccine.

This study is no longer recruiting patients.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00158795

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
Prophylaxis of Haemophilus influenza type b disease
 Vaccine: Haemophilus Influenza type b vaccine
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Official Title: An Open, Randomised Post-Marketing Clinical Trial to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals’ Haemophilus Influenzae Type b (Hib) Vaccine Co-Administered with Chinese Local DTPw Vaccine When Compared to Chinese Local DTPw Vaccine Administered Alone, in Healthy Infants at 3, 4 and 5 Months of Age.

Further Study Details: 
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. "
Expected Total Enrollment:  460

Study start: January 2005

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   -   4 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

"Inclusion:  A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.

Exclusion:

 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."

Location Information


China
      Nanning,  China

Study chairs or principal investigators

Clinical Trials,  Study Director,  GlaxoSmithKline   

More Information

Study ID Numbers:  104124
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158795
Health Authority: China: State Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13

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