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| Sponsored by: |
GlaxoSmithKline |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00345579 |
Purpose
The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.
This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
| Condition | Intervention | Phase |
|
Haemophilus Influenza Infections Meningococcal Infections |
Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 Biological: ActHIB Biological: Pediarix/Infanrix Penta |
Phase III |
| MedlinePlus related topics: | Flu |
| ChemIDplus related topics: | Tetanus Vaccine Meningococcal Vaccines |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study |
| Official Title: | Single-Blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age. |
| Enrollment: | 4429 |
| Study Start Date: | September 2006 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| Group A: Experimental |
Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014
3-dose intramuscular injection
Biological: Pediarix/Infanrix Penta
3-dose intramuscular injection
|
| Group B: Active Comparator |
Biological: ActHIB
3-dose intramuscular injection
Biological: Pediarix/Infanrix Penta
3-dose intramuscular injection
|
Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.
Eligibility
| Ages Eligible for Study: | 6 Weeks to 12 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Contacts and Locations![]() |
Show 23 Study Locations |
| GlaxoSmithKline |
| Study Director: | Clinical Trials | GlaxoSmithKline |
More Information
Booster study 
  |
| Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
| Study ID Numbers: | 105987 |
| First Received: | June 26, 2006 |
| Last Updated: | September 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00345579 |
| Health Authority: | United States: Food and Drug Administration; Mexico: Federal Commission for Protection Against Health Risks |
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