novel coronavirus (covid-19) study needing participants who have yet to receive covid-19 and hpv vaccines

Has Your 9-11 Year Old Received Their Covid-19 and HPV Vaccines?

If not, please consider this clinical research study giving a COVID-19 vaccination along with HPV vaccination.

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Study Overview

The purpose of this study is to see if a vaccine for HPV-related cancers and diseases is effective and works well when the first dose is given along with the first dose of a vaccine to prevent COVID-19. This clinical study will help researchers learn:

What requirements are in place to help protect clinical study participants?

There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research trials. These rules are put in place to make sure trials follow strict scientific and ethical guidelines. Before a clinical research trial can begin, a review board must review the trial. This group is called an IRB or institutional review board. An IRB is made up of doctors, scientists, and members of the community.

Who Can Join?

To participate in the V503-076 study, your child must be between 9-11 years of age and:

There are other rules for taking part that the study staff will discuss with you and your child.

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What will happen if my child takes part?

Screening Period

(About 1 Day)

To ensure your child qualifies, study staff will:

  • Conduct Physical Exams
  • Talk about your child’s medical history
  • Perform blood tests

Treatment Period

(Up to 8 Months)

If your child qualifies and both of you agree to take part, your child will:

  • Visit in-person your local research clinic
  • Have Physical Exams
  • Have blood tests
  • Maintain an electronic diary of their health (parent/caregiver assisted)
  • Receive study vaccinations at protocol specified intervals
  • Review Medication and Non-Study Vaccination (parent/caregiver assisted)
  • Review any side effects (parent/caregiver assisted)

Follow-Up Period

(About 1 month)

Your local study staff will schedule an in-clinic visit about 1 month after the Treatment Period to:

  • Review Medication and Non-Study Vaccination
  • Talk about electronic diary entries
  • Return electronic diary device
  • Have blood tests
  • Review any side effects

Why participate in this study?

All participants will receive HPV vaccination and Covid-19 vaccination. Both of the vaccines in this study are investigational. If the study vaccines work, your child may receive a health benefit (this means the HPV vaccine may help prevent certain types of HPV-related cancers and diseases that may occur later in life and the Covid-19 vaccine may help prevent Covid-19). If the study vaccines do not work, your child may not receive a health benefit. By taking part, your child will help researchers learn more about the vaccines, which may help people in the future. All study vaccines and study-related procedures are at no cost to participants or their insurance. Participants may be reimbursed for each study visit to help cover the costs of travel and expenses (i.e., parking, meals, etc.)

  • Study-Related Care

Is this mandatory?
Will it cost anything?

Taking part in this trial is voluntary and you and your child may stop at any time for any reason. In addition, there is no cost for the study drug or study-related care, tests and exams.

To learn more about COVID-19

If you would like to see if your child is eligible to participate, please find a site near you.

Find A Site Near You

Where can I learn more?

If you're interested in learning more about the V503-076 study for your child, including potential risks and benefits of participation, you can find additional details at CTGOV.