Not Signed In - [ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]
Haemophilus ducreyi Infection |
|
|
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.
|
Purpose
| 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.
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
Eligibility
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.
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
Clinical Trials, Study Director, GlaxoSmithKline
More Information
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
Resources
- Chancroid (Centers for Disease Control and Prevention)
email this page
print this page
bookmark this page
feedback on this page
