DMID 20-0009 (Childhood Flu Vaccination) - Clinical Trial

What is the Purpose of this Study?

We want to find out how well an experimental flu vaccine works in children. The vaccine is given as a spray into your child's nose. This study is part of a broader plan to discover flu vaccines that work better than the ones we use now.

What is the Condition Being Studied?

Influenza Vaccination in Children

Who Can Participate in the Study?

Children who:
- Are 6 months through 17 years of age
- Live in the Triangle area
- Are generally healthy
- Do not have asthma, chronic sinus infections, Guillain-Barre Syndrome, or cancer
- Are not immunosuppressed
- Have not gotten a flu shot or been treated for flu in the past 4 months

For more information about who can be in this study, please contact the study team at DVTUstudies@dm.duke.edu or 919-971-5649.

What is Involved?

If you and your child choose to join the study, you will visit our clinic at least 3 times. The study's schedule will be as follows:

Day 1: We will draw blood from your child and rinse out their nose. We will also give the vaccine or placebo (salt water nasal spray that does not contain vaccine) at this visit. Your child has a 2 out of 3 chance of getting the real vaccine.

Day 4: We will call you to see how your child feels and if there are any side effects after the vaccine.

Day 8: We will call you again to see how things are going and if there are any side effects after the vaccine.

Day 29 (4 weeks after the first visit): We will draw blood from your child and rinse out their nose to see how well the vaccine worked. At this visit, we will also give your child the regular flu shot.

Day 57 (4 weeks after the regular flu shot): We will draw blood from your child and rinse out their nose to see how well the regular flu shot worked.

April 2023: We will call you to see how things are going and if your child had any flu-like symptoms since their last visit.

You and your child's participation will end after the phone call in April. We will pay you for your and your child's time on the study.

You can click the following link to learn more about the study and sign your child up: https://duke.qualtrics.com/jfe/form/SV_3lWO8ZTEy0QCWfc

Study Details

Full Title
A Phase 1b, double-blind, randomized, dose-escalating, age de-escalating, placebo-controlled study to assess the safety and immunogenicity of one or two doses of Sing2016 M2SR H3N2 influenza vaccine delivered intranasally in a healthy pediatric population 6 months through 17 years of age.
Principal Investigator
Pediatric Infectious Diseases Specialist
Protocol Number
IRB: PRO00108675
NCT: NCT04960397
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698