Safety & Immunogenicity of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age

Condition(s) targeted: Haemophilus Infections; Meningococcal Infections

Intervention: compound # 792014 (Biological); Hib-MenCY-TT vaccine (Biological); monovalent Hib vaccine (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

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

The booster phase of the study will also evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 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: Safety: Hib-MenCY-TT vaccine vs monovalent Hib vaccine with respect to AEs post booster.

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 booster phase of the study. The objectives & outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)

Minimum age: 12 Months. Maximum age: 15 Months. 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.

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.

GSK Clinical Trials Call Center, Mexico City 4530, Mexico; Recruiting
GSK Clinical Trials Call Center, Phone: +1-877-379-3718

GSK Clinical Trials Call Center, Mexico, D.F. 6720, Mexico; Recruiting
GSK Clinical Trials Call Center, Phone: +1-877-379-3718

GSK Clinical Trials Call Center, Birmingham, Alabama 35205, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Birmingham, Alabama 35244, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Salinas, California 93901, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Fountain Valley, California 92708, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Fresno, California 93726, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, West Covina, California 91790, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Madera, California 93637, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Fresno, California 93710, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Boulder, Colorado 80303, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Longmont, Colorado 80501, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Plantation, Florida 33324, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Nampa, Idaho, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Lexington, Kentucky 40503, United States; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Bossier City, Louisiana 71111, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, St Paul, Minnesota 55108, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Las Vegas, Nevada 89104, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Syracuse, New York 13210, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Ithaca, New York 14850, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Raleigh, North Carolina 27609, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, North Canton, Ohio 44720, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Wexford, Pennsylvania 15090, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Kingsport, Tennessee 37660, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Salt Lake City, Utah 84121, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, West Jordan, Utah 84088, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, South Jordan, Utah 84095, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Pleasant Grove, Utah 84062, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Ogden, Utah 84405, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Orem, Utah 84057, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Madison, Wisconsin 53792, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

Primary Study

Starting date: July 2007
Last updated: April 4, 2008