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| Sponsored by: |
GlaxoSmithKline |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00127855 |
Purpose
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.
| Condition | Intervention | Phase |
|
Haemophilus Infections Meningococcal Infections |
Biological: Hib-MenCY-TT vaccine |
Phase II |
| MedlinePlus related topics: | Flu Memory |
| ChemIDplus related topics: | Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2003 |
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to ActHIB® (a Hib conjugate vaccine licensed in Australia) and Menjugate® (although use of Meningitec® was planned, Menjugate® was actually used due to vaccine availability. Both are MenC vaccines licensed in Australia). All vaccines were administered at 2, 4, and 6 months of age. The non-inferiority of immune responses to Hib and MenC in subjects receiving Hib-MenCY-TT vaccine was compared to the immune responses in recipients of the active control vaccines. In addition, the immunogenicity to MenY in recipients of Hib-MenCY-TT vaccine was summarized. Immune memory was assessed at 11 to 14 months of age via the adminstration of plain polysaccharide PRP and Men ACWY vaccines.
Eligibility
| Ages Eligible for Study: | 6 Weeks to 12 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
More Information
| Study ID Numbers: | 792014/001, 792014/002 |
| First Received: | August 8, 2005 |
| Last Updated: | October 10, 2006 |
| ClinicalTrials.gov Identifier: | NCT00127855 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
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