If you have a child between 6 months and 11 years old who has not yet received a COVID-19 vaccine, please consider the HUMMINGBIRD research study.
Study Overview
The HUMMINGBIRD study, for children 6 months to 11 years old, is testing an investigational vaccine (also known as a study vaccine) called NVX-CoV2373, designed to prevent COVID-19. The HUMMINGBIRD study will test the study vaccine against a placebo to make sure the vaccine is safe and effective in children. More than 49,000 clinical trial participants (12 years and older) have been vaccinated with NVX-CoV2373 for the prevention of mild, moderate, or severe COVID-19. NVX-CoV2373 has been authorized in various countries for adolescents and adults 12 years of age and older.
Now, researchers are evaluating the vaccine in younger children. Three age groups will be recruited, starting with the oldest age group, and moving to younger age groups over time. HUMMINGBIRD is a Phase 2/3 study sponsored by Novavax, Inc., a US-based pharmaceutical company. This global trial is expected to begin in the United States in August 2022 and end in November 2025.
This clinical study will help researchers learn:
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If the vaccine is safe for children from 6 months to 11 years of age
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If the vaccine is as effective for children as it is for young adults
Medical Condition
COVID-19
Product
Vaccine
Phase
2/3
Locations
Argentina | Brazil | Colombia | Mexico | Philippines | South Africa | Spain | United Kingdom | United States
Enrollment
3,600
Trial Dates
August 2022 -
November 2025
Who can join?
To be eligible for this study, your child must:
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Be in good health at time of participation
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Be between 6 months and 11 years of age
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Not have received a previous vaccine to protect against COVID-19
This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you and your child.
What will happen if your child takes part?
If you agree for your child to take part in this study, you will both attend a study screening visit and return to the study site within a month for an enrollment visit (screening and enrollment may take place on the same day in some instances). Once enrolled, you can expect to:
- Bring your child to the study site at least 8 times over the course of approximately 2 years.
- Have at least 3 telephone calls with the study team over approximately 2 years.
- Download an eDiary smartphone application to answer questions about your child's health or, if needed, be provided with a device for eDiary reporting of symptoms and health status updates.
- Have blood tests, physical examinations, and other assessments performed on your child as part of this study.
The first injections will be given during the first 2 visits to the site (21 days apart). About 6 months later, your child will receive their third injection. Depending on the group they are enrolled in (by chance), they may receive up to 2 more injections over the remaining study period, and followed for safety for up to about 2 years.
You will be compensated for your time and travel regardless of your immigration status. Transportation to the study site may also be provided, as available. No health insurance is required to participate.
FAQs
What is a clinical study?
A clinical study (e.g., HUMMINGBIRD) involves careful research that is intended to add to medical knowledge related to the prevention of diseases or conditions (e.g., COVID-19). Clinical studies enroll volunteers (also called participants) to help researchers compare a study vaccine (or drug) to a placebo, to see how the new vaccine works.
What is a study vaccine?
A study vaccine is a vaccine that is being tested in clinical studies. NVX-CoV2373 is the study vaccine in the HUMMINGBIRD study. A study vaccine is one that has not been approved by regulatory agencies, such as the United States (US) Food and Drug Administration (FDA), European Union European Medicines Agency (EMA), or others. However, every study vaccine must be reviewed and monitored by an independent ethics committee for testing in clinical study participants.
Why is the HUMMINGBIRD study important?
Coronavirus disease 2019 (COVID-19) is an infectious disease that affects different people in different ways. Researchers continue to explore possible vaccines against the virus (SARS-CoV-2) that causes COVID-19 in children.
The HUMMINGBIRD study, for children 6 months to 11 years old, is testing a study vaccine called NVX-CoV2373 that is designed to prevent COVID-19. More than 49,000 participants (12 years and older) have been vaccinated with NVX-CoV2373 for the prevention of mild, moderate, or severe COVID-19 symptoms. NVX-CoV2373 has been authorized in many countries for adolescents and adults 12 years of age and older.
Pharmaceutical companies use clinical research studies like this one to learn more about study vaccines before they are made available to the public. Study volunteers can help us in this important research. Thank you for considering your child’s participation in this study.
What makes the HUMMINGBIRD study vaccine different?
The study vaccine, NVX-CoV2373, differs from other authorized or approved vaccines in the way it is designed to provide COVID-19 virus protection. NVX-CoV2373 is a protein-based vaccine. The study vaccine introduces your child’s body to non-infectious parts (antigens) of the SARS‑CoV‑2 virus so their immune system may better recognize the virus and fight it if they are ever exposed to the virus. This approach is similar to annual flu shots and other protein-based vaccines your child may have received for hepatitis B and human papillomavirus (HPV).
Why participate in this study?
A clinical study provides information that helps researchers develop new vaccines. The results of the HUMMINGBIRD study can provide important information about the prevention of COVID-19 in children. Current vaccines and treatments for diseases are only available because of research study volunteers.
What requirements are in place to help protect clinical trial participants?
There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research studies. These rules are put in place to make sure studies follow strict scientific and ethical guidelines. Before a clinical research study can begin, a review board must review the study. This group is called an IRB (Institutional Review Board) or EC (Ethics Committee). An IRB/EC is made up of doctors, scientists, and members of the community.
What are my costs to take part in this study?
You do not have to pay for the study vaccine or placebo, study supplies, or tests that are part of the research study.
What risks are involved if I decide to have my child participate?
There are possible risks involved with any clinical study. The study doctor will review the risks with you, and your child will be closely monitored throughout the study.
Novavax’s COVID-19 Vaccine: Explained
Thank you for your interest in the HUMMINGBIRD pediatric COVID-19 vaccine study.
If you would like to see if your child is eligible to participate, please find a site near you.
Find a site near youWhere can I learn more?
If you're interested in learning more about the Novavax COVID-19 study, including potential risks and benefits of participation, you can reach out to a study doctor at a Site Near You.
You can also contact the Novavax Global Customer Experience Center:
