Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Haemophilus Infections; Meningococcal Infections
Intervention: Hib-MenCY-TT vaccine (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
This study is evaluating the safety and immunogenicity 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. The study will also evaluate the
safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving
licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and
Varivax® at 12 to 15 months of age. The study will evaluate if 3 different manufacturing lots
of Hib-MenCY-TT vaccine are consistent.
Clinical Details
Official title: Immunogenicity Study to Evaluate 3 Hib-MenCY-TT Vacc.Lots &GSK Biologicals' Hib & N. Meningitidis Serogroups C&Y-Tetanus Toxoid Conjugate Vacc.Combined vs Monovalent Hib Vacc. in Healthy Infants at 2,4,6 & 12 to 15mths
Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluate antibody responses to Hib-MenCY-TT vaccine and co-administered vaccines. Evaluate the safety profile of Hib-MenCY-TT vaccine.
Detailed description:
"• Experimental design: randomized, controlled, multinational study, with four parallel
groups.
- Investigational vaccine: 3 lots of Hib-MenCY-TT vaccine.
- Control: monovalent Hib vaccine.
- Visits: Cohort 1 - Six scheduled visits per subject at 2, 4, 6, 7, 12-15, and 13. 5-16. 5
months of age with blood sample collected at 3 visits to evaluate the immune response.
Cohort 2 - Four scheduled visits per subject at 2, 4, 6, and 12-15 months of age. There
will be a final contact with each subject 6 months after booster vaccination for safety
follow up and study conclusion.
- Duration of study: 16 to 19 months. "
Eligibility
Minimum age: 6 Weeks.
Maximum age: 12 Weeks.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy infants without major congenital illness, immunosuppression, or chronic
disease born at 36 to 42 weeks of gestation, and between 6 and 12 weeks of age at
enrollment.
Exclusion Criteria:
- Infants should not have received any investigational drug, vaccine (other than a birth
dose of hepatitis B vaccine), chronic immunosuppressants, or immunoglobulin or blood
products.
Locations and Contacts
GSK Clinical Trials Call Center, Hoover, Alabama 35216, United States
GSK Clinical Trials Call Center, Birmingham, Alabama 35235, United States
Additional Information
Starting date: February 2006
Last updated: May 28, 2008
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