Studies Open for Enrollment

A Phase IIIb Study of the Immunogenicity and Safety of the Hepatitis A Vaccine, Havrix, Administered with the Measles-mumps-rubella Vaccine, M-M-RII, and the Varicella Vaccine, Varivax.

This study will review whether Havrix, a licensed vaccine, is safe and capable of producing an immune response against hepatitis A when given to children younger than 2 years of age and at the same time or different times as M-M-RII and Varivax. In this study, Havrix will be given alone or with the M-M-RII and Varivax vaccines. One of the purposes of this study is to evaluate the safety and immune response of Havrix in children 15 months of age. The study will also show whether Havrix changes the effectiveness of M-M-RII and VARIVAX, and whether M-M-RII and VARIVAX change the effectiveness of Havrix.

Candidates
As a multi-center study, approximately 1,468 children will be enrolled in this study nationally, with about 80 enrolled through the Children’s Hospital of Pittsburgh Vaccine Center. With certain restrictions, all healthy 12-month-olds are eligible.
Boys: 12 months old
Girls: 12 months old

Requirements
Participants will visit Children’s Vaccine Center for appointments. A physical exam will be performed at the first visit, and each participant will be randomly assigned to one of two study groups. For the first group, the first dose of Havrix is administered at the same time as M-M-RII and Varivax. The second group delays the first dose of Havrix until one month after the other two vaccines are administered. The parents or guardians of each participant will be required to complete diary cards to record the bedtime temperature of the participant at various intervals during the study. The parents or guardians of each participant will receive a telephone call about 5 months after the last visit to check on the participant’s general health.
Visits: 5
Duration: 18 months

Status: Open for Enrollment

How to Participate:
To get started, please contact:
Cheryl Rosenberg, LPN, CCRC
412-692-7351

Additional Resources
Alternate Study Description at National Institutes of Health

Hepatitis

Principal Investigator
Marian G. Michaels, MD, MPH
Infectious Diseases

Source of Support
GlaxoSmithKline Biologicals