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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
Must not have
Female who is pregnant or breastfeeding
Any history of myocarditis or pericarditis
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
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently pregnant or breastfeeding.
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I have had myocarditis or pericarditis in the past.
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I have been vaccinated against COVID-19.
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I have an autoimmune disease that needs treatment.
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I have been diagnosed with MIS-C before or currently have it.
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I haven't taken strong immune system suppressing drugs or had radiation in the last 60 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month after dose 4 for participants who received 3 prior doses of bnt162b2 3 µg and a fourth dose of bivalent bnt162b2 to study c4591007 participants ≥6 months to <5 years of age who received 3 doses of bnt162b2 3 µg
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month after dose 4 for participants who received 3 prior doses of bnt162b2 3 µg and a fourth dose of bivalent bnt162b2 to study c4591007 participants ≥6 months to <5 years of age who received 3 doses of bnt162b2 3 µg for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
77 Previous Clinical Trials
112,271 Total Patients Enrolled
PfizerIndustry Sponsor
4,675 Previous Clinical Trials
28,713,489 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,754,345 Total Patients Enrolled

Media Library

Bivalent BNT162b2 Omicron containing vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05543616 — Phase 2 & 3
Coronavirus 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)
Coronavirus 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
~760 spots leftby Aug 2025
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