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Vaccine

COVID-19 Vaccine for Children

Phase 2 & 3
Recruiting
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy male or female participants ≥2 years to <12 years of age, at the time of enrollment
Phase 2/3: Healthy male or female participants ≥6 months to <5 years of age at the time of randomization/enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (before dose 1), 1 month after dose 1 for participants ≥2 to <12 years who received 1 dose bnt162b2 (omi xbb.1.5), 1 month after dose 3 for c4591007 participants ≥2 to <5 years, and 1 month after dose 2 for c4591007 participants ≥5 to <12 yrs
Awards & highlights

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.

Who is the study for?
Healthy children aged 6 months to less than 12 years are eligible for this trial. They must not have had any previous COVID-19 vaccinations, a history of severe vaccine reactions, or conditions like MIS-C, autoimmune diseases, myocarditis/pericarditis. Pregnant/breastfeeding females and those on immunosuppressants are excluded.Check my eligibility
What is being tested?
The study is testing variant-adapted BNT162b2 RNA vaccines targeting Omicron variants in healthy children. It's divided into substudies based on age and prior vaccination status with different doses administered as shots depending on the group.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions such as soreness at the injection site, fever, fatigue, headache, muscle pain, chills and possibly allergic reactions although rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy child aged 2 to 11 years.
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I am a healthy child between 6 months and 5 years old.
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I am a healthy child aged 6 months to under 5 years.
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I am a healthy child between 6 months and 5 years old.
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I am a healthy child aged 6 months to just under 4 years and 3 months.
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I am between 5 and 11 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline (before dose 1), 1 month after dose 1 (groups 2 and 4), 1 month after dose 2 (group 1), and 1 month after dose 3 (group 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (before dose 1), 1 month after dose 1 (groups 2 and 4), 1 month after dose 2 (group 1), and 1 month after dose 3 (group 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SSA - Ph 1 dose finding, percentage of participants reporting adverse events
SSA - Ph 1 dose finding, percentage of participants reporting serious adverse events
SSA - Ph 1 dose finding, percentage of participants reporting systemic events
+34 more
Secondary outcome measures
SSA - Ph 1 dose finding, geometric mean fold rise elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant vaccine type (if applicable) in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age
SSA - Ph 1 dose finding, geometric mean titers elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant vaccine type (if applicable) in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age
SSA - Ph 1 dose finding, percentage of participants with seroresponse elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant-adapted vaccine type in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age
+14 more

Trial Design

23Treatment groups
Experimental Treatment
Group I: Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week scheduleExperimental Treatment1 Intervention
Injection in the muscle at 0- and 8-weeks
Group II: Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week scheduleExperimental Treatment1 Intervention
Injection in the muscle at 0- and 8-weeks
Group III: Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single doseExperimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group IV: Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single doseExperimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group V: 6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)Experimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group VI: 6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)Experimental Treatment2 Interventions
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Group VII: 6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)Experimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group VIII: 6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)Experimental Treatment3 Interventions
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Group IX: 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)Experimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group X: 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2)Experimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group XI: 3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1)Experimental Treatment1 Intervention
Injection in the muscle, 2 doses 2 months apart
Group XII: 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week scheduleExperimental Treatment1 Intervention
Injection in the muscle at 0-, 3-, and 11-weeks
Group XIII: 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)Experimental Treatment2 Interventions
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Group XIV: 3 microgram dose, 2 Years to <5 Years (Substudy E, Group 1)Experimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group XV: 3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)Experimental Treatment2 Interventions
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Group XVI: 10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)Experimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group XVII: 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)Experimental Treatment2 Interventions
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Group XVIII: 10 microgram dose, 5 to <12 Years (Substudy D, Group 3)Experimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group XIX: 10 microgram dose, 5 to <12 Years (Substudy D, Group 2)Experimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group XX: 10 microgram dose, 5 to <12 Years (Substudy D, Group 1)Experimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group XXI: 10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2)Experimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group XXII: 10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)Experimental Treatment1 Intervention
Injection in the muscle, 1 dose
Group XXIII: 10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)Experimental Treatment1 Intervention
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor
66 Previous Clinical Trials
104,541 Total Patients Enrolled
20 Trials studying COVID-19
93,377 Patients Enrolled for COVID-19
PfizerIndustry Sponsor
4,580 Previous Clinical Trials
14,630,511 Total Patients Enrolled
67 Trials studying COVID-19
1,434,203 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,485 Previous Clinical Trials
11,807,386 Total Patients Enrolled
50 Trials studying COVID-19
1,423,024 Patients Enrolled for COVID-19

Media Library

Bivalent BNT162b2 Omicron containing vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05543616 — Phase 2 & 3
COVID-19 Research Study Groups: 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1), 6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1), 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1), Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week schedule, Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week schedule, 3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1), 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2), 6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1), 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3), 6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1), 10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1), 10 microgram dose, 5 to <12 Years (Substudy D, Group 1), 10 microgram dose, 5 to <12 Years (Substudy D, Group 2), 10 microgram dose, 5 to <12 Years (Substudy D, Group 3), 3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1), 10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1), 6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1), Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose, 10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1), 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week schedule, Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose, 3 microgram dose, 2 Years to <5 Years (Substudy E, Group 1), 10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2)
COVID-19 Clinical Trial 2023: Bivalent BNT162b2 Omicron containing vaccine Highlights & Side Effects. Trial Name: NCT05543616 — Phase 2 & 3
Bivalent BNT162b2 Omicron containing vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05543616 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Georgia
What site did they apply to?
Clinical Neuroscience Solutions, Inc.
Accel Research Sites Network- Nona Pediatric Center
Rophe Adult and Pediatric Medicine/SKYCRNG
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Because I think I can be.a Good fit for this trial.
PatientReceived 2+ prior treatments
~1520 spots leftby Aug 2025