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| Tracking Information | |||||
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| First Received Date ICMJE | August 8, 2005 | ||||
| Last Updated Date | October 30, 2008 | ||||
| Start Date ICMJE | March 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Evaluate antibody responses to Hib and meningococcal serogroups C an Y in 3 different Hib-MenCY-TT formulations as compared to licensed Hib and meningococcal serogroup C conjugate vaccines | ||||
| Original Primary Outcome Measures ICMJE |
Evaluate antibody responses to Hib and meningococcal serogroups C an Y in 3 different Hib-MenCY-TT formulations as compared to licensed Hib and meningococcal serogroup C conjugate vaccines. | ||||
| Change History | Complete list of historical versions of study NCT00127855 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Evaluate the safety and reactogenicity of the 3 Hib-MenCY-TT formulations. Evaluate antibody persistence and immune memory induced by Hib-MenCY-TT. Evaluate immune responses to co-administered DTaP-IPV-HepB and 7-valent pneumococcal vaccines. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine | ||||
| Official Title ICMJE | See Detailed Description | ||||
| Brief Summary | This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age. |
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| Detailed Description | Evaluate immuno. (incl. immune memory),reacto & safety of 3 diff. formul. of GSKBio combined Haemophilus influenzae typeb-meningococcal serogroups CY conjugate vaccine given concomitantly with Infanrix®penta DTaP-IPV-HepB vaccine) & Prevenar® (7-valent pneumo. vaccine) vs ActHIB® (Hibvaccine) & Meningitec® (meningococcal serogroupC vaccine) given concomitantly with Infanrix®penta (DTaP-IPV-HepB vaccine) & Prevenar® (7-valent pneumococcal vaccine)in infants according to a 2-4-6 mth schedule |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Biological: Hib-MenCY-TT vaccine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Nolan T, Lambert S, Roberton D, Marshall H, Richmond P, Streeton C, Poolman J, Boutriau D. A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine. 2007 Dec 12;25(51):8487-99. Epub 2007 Oct 25. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 400 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 6 Weeks to 12 Weeks | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Australia | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00127855 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | 792014/001, 792014/002 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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