To Assess Safety and Reactogenicity of GSK Biologicals'' Haemophilus Influenza Type b Vaccine Co-Administered with or Without Chinese DTPw Vaccine. - Article Avian flu; Bird flu; Bird flu (avian influenza); H5N1
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.
|Prophylaxis of Haemophilus influenza type b disease || Vaccine: Haemophilus Influenza type b vaccine ||Phase IV |
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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.
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
Accepts Healthy Volunteers
"Inclusion: A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
Clinical Trials, Study Director, GlaxoSmithKline
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