Upstate Active Clinical Trials
Study Title:Immunogenicity and safety study of GSK Biologicals’ quadrivalent influenza vaccine (GSK2282512A) compared to Fluzone® Quadrivalent in children 6 to 35 months of age. 201234 (FLU-Q-QIV-022)
What is the purpose of the study? (in Layman's terms, please describe the study)This study is being done to learn more about:
• How well a new flu vaccine works in children 6 to 35 months of age
• The safety of the new flu vaccine.
Influenza or ‘Flu’ is an infection of the breathing pipes and lungs. It is caused by a virus. Vaccination is the best way to prevent Flu. There are different families of Flu viruses. The two Flu virus families that cause most Flu infections are called “A” and “B”. Different kinds of viruses within each family are called “strains”. These strains in the A and B families usually change a little bit each year. Because the Flu strains usually change each year, people are advised to get vaccinated against Flu every year.
Until very recently, the Flu vaccine that is given every year is made of a killed virus from three different strains. It is called a trivalent influenza vaccine or TIV. Two strains in the vaccine are from the A family and one is from the B family. In this study, GSK is testing a quadrivalent influenza vaccine or QIV, made of two A strains and two B strains. GSK would like to find out whether adding a second B strain can protect better against Flu infection.
Upstate Institutional Review Board (IRB) Number:627873
Study/Protocol ID:(GSK2282512A) 201234 (FLU-Q-QIV-022)
Study Phase:Phase III
Patient Age Group:Children
Principal Investigator:Joseph B Domachowske
Who is eligible?Your child can only be in this study if all of the following apply to him/her:
• Your child is between, and including, 6 and 35 months of age at the time of the first vaccination,
• You give written consent to let your child participate
• You are able to follow the study procedures
• Your child does not take certain medication
• Your child does not have certain diseases
• Your child is not allergic to Flu vaccines or eggs. Tell your study doctor if your child has any allergies. The study doctor will then see whether your child can receive the study vaccine or not.
• The study doctor will also check some other aspects before your child can join this study.
Who can I contact for more information?
Name: Jodi Halczyn