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Vaccine-Preventable Diseases and Specific Vaccines |
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Clinical Trial: Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines, Each Administered at 2, 4, 6, and 12 to 15 Months of Age.
This study is currently recruiting patients.
Verified by GlaxoSmithKline August 2005
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Purpose
This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine, and with live, attenuated varicella vaccine will be assessed with administration of the booster dose.
| Condition | Intervention | Phase |
|---|---|---|
| Invasive bacterial disease caused by Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y. | Vaccine: Hib Men CY-TT vaccine | Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II, Open, Randomised, Controlled, Multicentre Primary and Booster Vaccination Study of GSK Biologicals'''' Hib-MenCY-TT Conjugate Vaccine Versus ActHIB® (Licensed Hib Conjugate Vaccine) and MenC Conjugate Licensed Vaccine When Given According to the 2-4-6 Month Schedule to Healthy Infants with a Booster Dose at 12 to 15 Months of Age
Further Study Details:
Primary Outcomes: Evaluate antibody responses to Hib with Hib-MenCY-TT as compared to licensed Hib conjugate vaccine. Evaluate antibody responses to MenC with Hib-MenCY-TT as compared to licensed MenC conjugate vaccine. Evaluate immune responses to co-administered measle
Secondary Outcomes: Evaluate the safety profile of Hib-MenCY-TT.Evaluate persistence of antibodies prior to booster dose in all treatment groups.
Expected Total Enrollment: 1100
Secondary Outcomes: Evaluate the safety profile of Hib-MenCY-TT.Evaluate persistence of antibodies prior to booster dose in all treatment groups.
Expected Total Enrollment: 1100
Study start: April 2005
Eligibility
Ages Eligible for Study: 6 Weeks - 12 Weeks, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrolment, and vaccinated against hepatitis B at birth. Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunogelobulin or blood products.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00134719
Clinical Coordinator +1.877.379.37.18
Australia
Victoria, Australia; Recruiting
Study chairs or principal investigators
Clinical Trials, Study Director, GlaxoSmithKline
More Information
Study ID Numbers: 102370
Last Updated: August 24, 2005
Record first received: August 10, 2005
ClinicalTrials.gov Identifier: NCT00134719
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
Last Updated: August 24, 2005
Record first received: August 10, 2005
ClinicalTrials.gov Identifier: NCT00134719
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
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