Safety & Immunogenicity of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 Months of Age.

Condition(s) targeted: Haemophilus Infections; Meningococcal Infections

Intervention: compound# 792014 (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

The primary phase of this study is evaluating the safety 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.

Official title: Single-Blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Study design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety Study

Primary outcome: Safety: Hib-MenCY-TT vaccine vs monovalent Hib vaccine with respect to AEs post primary vaccination.

Secondary outcome: See Booster study posting (NCT00345683)

Detailed description: Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine Note: This protocol posting deals with the objectives & outcome measures for the primary phase of the study. The objectives & outcome measures for the booster phase are presented in a separate protocol posting (NCT00345683)

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 least 36 weeks of gestation, and between 6 and 12 weeks of age at enrollment.

- 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.

GSK Clinical Trials Call Center, Mexico City 04530, Mexico

GSK Clinical Trials Call Center, Little Rock, Alaska 72401, United States

GSK Clinical Trials Call Center, Phoenix, Arizona 85008, United States

GSK Clinical Trials Call Center, Salinas, California 93901, United States

GSK Clinical Trials Call Center, Boulder, Colorado 80304, United States

GSK Clinical Trials Call Center, Oaklawn, Illinois 60453, United States

GSK Clinical Trials Call Center, Lafayette, Indiana 47901, United States

GSK Clinical Trials Call Center, Des Monies, Iowa 50263, United States

GSK Clinical Trials Call Center, Munfordville, Kentucky 42765, United States

GSK Clinical Trials Call Center, Shreveport, Louisiana 71105, United States

GSK Clinical Trials Call Center, Springfield, Massachusetts 01101, United States

GSK Clinical Trials Call Center, Portage, Michigan 49024, United States

GSK Clinical Trials Call Center, St Paul, Minnesota 55108, United States

GSK Clinical Trials Call Center, North Syracuse, New York 13088, United States

GSK Clinical Trials Call Center, Raleigh, North Carolina 27609, United States

GSK Clinical Trials Call Center, Akron, Ohio 44308, United States

GSK Clinical Trials Call Center, Gresham, Oregon 97030, United States

GSK Clinical Trials Call Center, Pittsburg, Pennsylvania 15241, United States

GSK Clinical Trials Call Center, Charleston, South Carolina 29425, United States

GSK Clinical Trials Call Center, Kingsport, Tennessee 37660, United States

GSK Clinical Trials Call Center, Fort Worth, Texas 76102, United States

GSK Clinical Trials Call Center, Salt Lake City, Utah 84101, United States

GSK Clinical Trials Call Center, Madison, Wisconsin 53792, United States

Booster study

Starting date: September 2006
Last updated: May 6, 2008