Pfizer COVID-19 Vaccine Study for Children
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"We are no longer accepting volunteers for this study."
Age: under 12 years old
Gender:
Any
Healthy Volunteers: Yes
Keywords: BioNTech, BNT162b2, Child, Children, COVID, COVID-19, Pfizer, SARS-CoV-2, Vaccine, Vaccines
Type: Biological study, Phase 2/Phase 3
Target:
200 Participants
Investigator:
Description
(Photo: Heather Hazzan. Courtesy of SELF Magazine.)

The World Health Organization (WHO) has declared COVID-19 to be a pandemic (a disease that has spread all over the world and is affecting lots of people); finding a vaccine to prevent COVID-19 is an urgent need. This research study will evaluate whether the investigational or study vaccine (Pfizer-BioNTech) to prevent COVID-19 is safe, tolerable and produces immune response to the virus causing COVID-19.

Vaccines can help the body mount an immune response to serious infections in order to reduce the clinical symptoms associated with a disease. This research study involves an investigational vaccine (not approved by health authorities in children) to prevent COVID-19. To test this investigational vaccine for children, this study will be conducted in the following three age groups of children volunteers:

- 5 to less than 12 years of age,
- 2 to <5 years of age, and
- 6 months to < 2 years of age

The study will start with the oldest age group. The younger age groups will start depending on the safety information and antibody responses seen in the older age groups above them.

The Phase 2/3 study will evaluate the efficacy and safety of the vaccine dose determined in Phase 1 study. This study is randomized, double-blinded placebo-controlled study so your child may recieve active vaccine or placebo injection.

Six months following the 2nd injection, your family will be informed by the study team whether your child was given the placebo injection or the active investigational COVID-19 vaccine. If your child originally received placebo, your child will be offered the COVID-19 investigational vaccine as part of this study.
This study requires

Your child will have blood and nasal swabs taken during the study. Your child must provide these samples in order to take part in this study.

As a parent(s)/legal guardian(s), you may be required to complete an e-diary for your child. We will either give you a device (like a mobile phone) or ask you to download an application (app) to your smart phone if you have one.

Who can participate

-Healthy male or female participants ≥6 months to <12 years of age

-No female participants who are pregnant or breastfeeding

-No participants that are currently taking medications for COVID-19

-No participants with a history of immunodeficiency, autoimmune disease, certain bleeding disorders, severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)

Benefits and risks of participating
Risks and possible discomforts your child might have from the study procedures include:

Blood Samples: The risks and possible discomforts involved in taking blood include pain from inserting the needle, or less often, swelling, bruising, or infection around the vein where the blood is collected. Your child may feel dizzy or may faint.

Nasal Swabs: The risks and possible discomforts involved in taking nasal swabs may include pain or general discomfort. Sometimes it may cause the nose to bleed.

If the study vaccine is effective for your child, their chances of getting COVID-19 may be reduced. Vaccination with BNT162b2 has been shown to be effective in preventing COVID-19 in the groups of people already studied, but not yet in the age group of your child. Because of this, they still need to follow local recommendations about how to avoid COVID-19 (for example, social distancing and mask use). In addition, information learned from the research study may help other people in the future.
Compensation
You/your child will be paid $100 for each completed study visit to cover your out-of-pocket expenses related to this study, such as travel and parking.
Resources
Schedule
Study duration and period
Total duration of the study is 26 months.
Recruitment period
From May 17, 2021
Location
Clinical Translational Research Unit
800 Welch Road
Palo Alto, CA 94304
Contact
Jenna Bollyky, MD
Research Topic
Conditions:
  • COVID-19
  • SARS-CoV-2 Infection

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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