Assess Safety & Reactogenicity of GSK Biologicals' Hib Vaccine Co-administered With or Without Chinese DTPw Vaccine
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00158795
First received: September 8, 2005
Last updated: September 29, 2011
Last verified: September 2011
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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) |
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 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 |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013