Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines

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.

Official Title

A Multicentre Pry &Booster Vaccination Study of GSK Biologicals’ Hib-MenCY-TT Conjugate Vaccine vs ActHIB &MenC Conjugate Licensed Vaccine When Given According to the 2-4-6 Mth Schedule to Healthy Infants With Booster Dose at 12 to 15 Mths

Conditions

• Haemophilus Infections
• Meningococcal Infections

Study Type

Interventional

Study Design

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Stud

Further Details

• Primary Outcome Measures: 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 measles, mumps, and rubella combination vaccine
• Secondary Outcome Measures: Evaluate the safety profile of Hib-MenCY-TT; Evaluate persistence of antibodies prior to booster dose in all treatment groups

Study Start

April 2005

Eligibility & Criteria

• Ages Eligible for Study: 6 Weeks – 12 Weeks
• Genders Eligible for Study: Both

Inclusion 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
• Vaccinated against hepatitis B at birth
• Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.

Total Enrolment

1100

Contact Details

Australia: GSK Clinical Trials Call Center, Victoria, Australia