Upstate Active Clinical Trials
Study Title:A phase IIIA, randomized, observer-blind, controlled, multinational study to evaluate the safety
and immunogenicity of GSK Biologicals' MMR vaccine (209762) (Priorix®) compared to Merck & Co.,
Inc.s MMR vaccine (M-M-R®II or VaxPro), as a first dose, both co-administered with Varivax, Havrix (all
subjects) and Prevnar 13 (US subset) in healthy children 12 to 15 months of age.
What is the purpose of the study? (in Layman's terms, please describe the study)This study involves research about vaccines. Vaccines help protect against diseases. Researchers want to find out if the measles-mumps-rubella (MMR) vaccine works well when given during a child’s second year of life. The way to check if the vaccine works well is to take and test a blood sample before and after the shot is given.
Upstate Institutional Review Board (IRB) Number:624983
Study/Protocol ID:MMR - 162
Study Phase:Phase III
Patient Age Group:Children
Principal Investigator:Leonard B Weiner
Who is eligible?child can be in this study if he or she:
• Is between 12 and 15 months old.
• Is in good health.
• Have not had previous vaccinations against measles, mumps, rubella, chicken pox (varicella), or hepatitis A.
• Has no history of allergy to any part of the vaccine including gelatine, latex or neomycin.
• Has already received the 3-dose infant series of Prevnar 13 at least 60 days prior to study entry
• Has NOT already received a 4th shot of pneumococcal conjugate vaccine (Prevnar 13)
• Is not taking certain medications
About 1734 healthy children will take part in this study. Once we have 1734 children enrolled, we will stop inviting any more to join. The study will be done in the US, Estonia, and Taiwan.
Who can I contact for more information?
Name: Lori J Ferguson