The Norton Children’s Research Institute, affiliated with the UofL School of Medicine, is participating in a phase 2/3 clinical trial of the Pfizer-BioNTech COVID-19 investigational vaccine for healthy children. The study will evaluate safety, tolerability and generation of immune response in this age group.
The trial is now enrolling children ages 6 months to 4 years. The worldwide goal of enrolling children ages 5 to less than 12 years was met in June.
As the only site in Louisville, Kentucky, we offer children the opportunity to participate in this trial, which involves around 100 sites worldwide.
In the randomized clinical trial, two children will be assigned to receive the vaccine for every child who receives a placebo. The study is blinded, meaning that no one initially will know which injection they receive. Parents and caregivers will be asked to track changes to the child’s health in an electronic diary, and children will have at least six in-person visits over a two-year period, some to include blood draws.
Approximately 4,500 children around the world will be enrolled. Children ages 6 months to 4 years who are generally healthy are eligible to be included.
The trial is being led by Gary S. Marshall, M.D., Norton Children’s Infectious Diseases, affiliated with the UofL School of Medicine. Dr. Marshall is chief of the division of pediatric infectious diseases in the UofL School of Medicine Department of Pediatrics.
The clinical trial team has responded to the pandemic, treating children with COVID-19 and its consequences.
Volunteers can express their interest in having their child participate in a trial of the Pfizer vaccine for this age group.
How do I know if my child is eligible to participate in this study?
Children must be between 6 months and 4 years old, and should be generally healthy or have stable health conditions. Participants and their parents or guardians must be willing to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures. Children with certain medical conditions, such as immunodeficiency or serious autoimmune disease, may not be able to enroll. The best way to know if your child can participate is to indicate your interest and go through your child’s medical history with our research staff when they call. Signing up does not necessarily mean that your child will be chosen for participation.
What can I expect if I join the study?
If your child qualifies and chooses to enroll in the study, you will come to the research office at the Novak Center for Children’s Health in downtown Louisville, Kentucky. There, you will meet with a nurse coordinator who will review all of the details of the study with you and answer your questions. If you decide to participate, you will sign an informed consent form that gives details of the study procedures, any reasonably foreseeable risks, expected benefits, alternatives to participation, and an explanation of how your information will be kept confidential. Following that, your child will have a brief physical exam by a researcher, their blood will be drawn, and they will get an injection. You will keep an electronic diary of any symptoms for the next week, and you will return for your child’s second shot in three weeks. Several other visits will take place after that.
The child’s time in the study will last for a total of two years, but much of what happens beyond the first six months is the research team keeping track of how your child is doing.
If your child is randomly assigned to receive the placebo, they will be offered the active vaccine at their six-month study visit.
Is there a cost to participate?
There is no cost to participate. Qualified volunteers may receive study-related medical care and the investigational shot at no cost. All study participants will receive compensation to offset the costs of being in the study (including parking, meals and travel) as well as time spent doing study-related procedures.
What are the benefits of participating in this clinical trial?
Participating in this study means your child will be part of the historic fight to help end the devastating coronavirus pandemic. Children do get sick from COVID-19, and they also spread the virus to others. The vaccine that is being studied was shown to be safe and very effective in adults, but it cannot be approved in children until formal studies are done. Whether your child receives the vaccine initially or at the six-month visit, it is likely he or she will develop immunity to the virus. If the study shows that the vaccine is safe and produces a robust immune response, it will likely lead to making the vaccine available to all children.
What is an investigational vaccine?
Vaccines train the body’s immune system to fight against invaders such as viruses and bacteria. In this study, some participants will get an investigational vaccine that aims to prevent COVID-19. The investigational vaccine is still in the testing and evaluation phases and is not licensed for use in the general public. By June 2021, over 180 million people received a version of the same vaccine.
What is a placebo?
In this study, some participants will get a placebo instead of the investigational vaccine. A placebo looks like the investigational vaccine and is given the same way, but instead of containing the vaccine, it contains a saline (salt) solution with no active ingredients. Using a placebo in the study allows scientists to determine the level of immunity that the vaccine generates.
Can my child get COVID-19 from this investigational vaccine?
No, your child cannot get COVID-19 from this investigational vaccine. The investigational vaccine does not contain live coronavirus, and live coronavirus cannot result from vaccination. The vaccine uses messenger RNA to instruct your own cells to make the spike protein of the virus; your immune system then makes antibodies to that protein so you can be protected from the real infection.
Does my child qualify if they had a confirmed or suspected diagnosis of COVID-19?
Your child might be eligible even if he or she already had COVID-19.
How does this Pfizer vaccine compare to the one for children ages 12 to 15?
The vaccine being studied in this clinical trial is the same one that has been authorized for people ages 12 and older, although the dose may be different. In adults, this vaccine demonstrated 95% efficacy against COVID-19, and as of June 2021, over 180 million people in the U.S. received at least one dose. Preliminary data show the vaccine to be safe in children as well as able to generate a strong immune response.
Why are volunteers from diverse backgrounds needed?
Everybody is different, and we know that some medicines and diseases have different interactions in different groups of people. In this study, we need to make sure the vaccine is safe and effective for everyone, no matter what their racial, cultural, ethnic, and socioeconomic background is. It is important to note that COVID-19 has had a devastating effect on communities of color, making it especially important to develop vaccines that we are sure to work in individuals in this population.