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Study Summary
This trial studies the safety and effectiveness of a vaccine in young children, given in 3 or 4 doses, depending on their prior history of vaccination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am currently pregnant or breastfeeding.I am a healthy child aged 2 to 11 years.I have had myocarditis or pericarditis in the past.I have been vaccinated against COVID-19.I am a healthy child between 6 months and 5 years old.I haven't received blood products, immunoglobulin, or certain antibodies within the last 60 days, nor COVID-19 antibody therapy in the last 90 days.I have an autoimmune disease that needs treatment.I have been diagnosed with MIS-C before or currently have it.I haven't taken strong immune system suppressing drugs or had radiation in the last 60 days.I am a healthy child aged 6 months to under 5 years.I am a healthy child between 6 months and 5 years old.I am a healthy child aged 6 months to just under 4 years and 3 months.I am between 5 and 11 years old.You have a weakened immune system due to a health condition or medication.
- Group 1: 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
- Group 2: 6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
- Group 3: 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
- Group 4: Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week schedule
- Group 5: Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week schedule
- Group 6: 3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1)
- Group 7: 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2)
- Group 8: 6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)
- Group 9: 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)
- Group 10: 6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)
- Group 11: 10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)
- Group 12: 10 microgram dose, 5 to <12 Years (Substudy D, Group 1)
- Group 13: 10 microgram dose, 5 to <12 Years (Substudy D, Group 2)
- Group 14: 10 microgram dose, 5 to <12 Years (Substudy D, Group 3)
- Group 15: 3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
- Group 16: 10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)
- Group 17: 6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
- Group 18: Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose
- Group 19: 10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
- Group 20: 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week schedule
- Group 21: Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose
- Group 22: 3 microgram dose, 2 Years to <5 Years (Substudy E, Group 1)
- Group 23: 10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Will people aged 35 or more be able to participate in this research project?
"This clinical trial is currently enrolling children that are older than 6 months but younger than 11 years of age."
Is this research project seeking new participants?
"That is correct. The information available on clinicaltrials.gov affirms that this trial is still recruiting patients. It was originally posted on September 23rd, 2020 and was last updated on October 24th, 2020. There are 19 different enrolling sites and the goal is to have 2270 patients enrolled in total."
How many different medical clinics are conducting this research study?
"The trial is accessible at 19 sites; a few of these locations are Atlanta, Seattle and Boston. To limit travel barriers, patients are encouraged to choose the site location that is closest to them."
Might I be eligible to take part in this research project?
"The proposed study requires 2270 young patients that have contracted covid19 and fall between the age of 6 months to 11 years old. Additionally, they must meet the following conditions to be eligible: Substudy A, - Healthy male or female participants ≥6 months to <2 years of age, at the time of randomization."
What are the primary objectives of this research?
"The primary objective of this trial, which will be measured over a one-month period after the first dose, is to assess the percentage of participants who experience systemic events. Additionally, this trial will also evaluate secondary outcomes including the geometric mean titers elicited by the bivalent BNT162b2 vaccine in participants aged 6 months to 5 years, as well as the geometric mean fold rise elicited by the vaccine in participants aged 6 months to 2 years."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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