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Vaccine

Biological/Vaccine: BNT162b2 3mcg for COVID-19

Phase 2 & 3
Waitlist Available
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (before dose 1) and 1, 6, 12 (for the original bnt162b2 group only), and 24 (for the original bnt162b2 group only) months after dose 2
Awards & highlights

Study Summary

This trial is testing a new vaccine in children and young adults to see if it is safe and effective. If it is, then they will test it in infants.

Eligible Conditions
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline (before dose 1) and 1, 6, 12 (for the original bnt162b2 group only), and 24 (for the original bnt162b2 group only) months after dose 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (before dose 1) and 1, 6, 12 (for the original bnt162b2 group only), and 24 (for the original bnt162b2 group only) months after dose 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
In Phase 2/3 selected-dose (2-dose series), the difference in percentages of participants with seroresponse in participants ≥2 to <5 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study
In Phase 2/3 selected-dose (2-dose series), the difference in percentages of participants with seroresponse in participants ≥5 to <12 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study
In Phase 2/3 selected-dose (2-dose series), the difference in percentages of participants with seroresponse in participants ≥6 months to <2 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001
+15 more
Secondary outcome measures
In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs
In evaluable Phase 2/3 participants at selected dose level in each age group, Geometric Mean Titers of SARS-CoV-2 neutralizing titers with no serological or virological evidence of past SARS-CoV-2 infection
In evaluable Phase 2/3 participants at the dose level selected in each age group, Geometric Mean Fold Ratio in SARS-CoV-2 serum neutralizing titer from before vaccination to each subsequent time point
+4 more

Trial Design

21Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo, ≥5 to <12 Years (Troponin I Testing)Experimental Treatment1 Intervention
A separate cohort of participants to collect serum samples for potential troponin I testing
Group II: Mid-Dose, ≥6 Months to <2 YearsExperimental Treatment1 Intervention
Mid-Dose, (20mcg), 2 doses 21 days apart
Group III: Mid-Dose, ≥5 to <12 YearsExperimental Treatment1 Intervention
Mid-Dose, (20mcg), 2 doses 21 days apart
Group IV: Mid-Dose, ≥2 to <5 YearsExperimental Treatment1 Intervention
Mid-Dose, (20mcg), 2 doses 21 days apart
Group V: Low/Mid-Dose, ≥6 Months to <2 YearsExperimental Treatment1 Intervention
Low/Mid-Dose, (10mcg), 2 doses 21 days apart
Group VI: Low/Mid-Dose, ≥5 to <12 Years (Troponin I Testing)Experimental Treatment1 Intervention
Low/Mid-Dose (10mcg), 3 doses
Group VII: Low/Mid-Dose, ≥5 to <12 YearsExperimental Treatment1 Intervention
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Group VIII: Low/Mid-Dose, ≥2 to < 5 YearsExperimental Treatment1 Intervention
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Group IX: Low-Dose, ≥6 Months to <2 Years (3-dose regimen)Experimental Treatment1 Intervention
Low-Dose (3mcg), 3 doses
Group X: Low-Dose, ≥6 Months to <2 YearsExperimental Treatment1 Intervention
Low-Dose (3mcg), 2 doses 21 doses apart
Group XI: Low-Dose, ≥2 to <5 Years (3-dose regimen)Experimental Treatment1 Intervention
Low-Dose (3mcg), 3 doses
Group XII: Low-Dose, ≥2 to <5 YearsExperimental Treatment1 Intervention
Low-Dose (3mcg), 2 doses 21 days apart
Group XIII: High-Dose, ≥6 Months to <2 YearsExperimental Treatment1 Intervention
High-Dose, (30mcg), 2 doses 21 days apart
Group XIV: High-Dose, ≥5 to <12 YearsExperimental Treatment1 Intervention
High-Dose (30mcg), 2 doses 21 days apart
Group XV: High-Dose, ≥2 to <5 YearsExperimental Treatment1 Intervention
High-Dose, (30mcg), 2 doses 21 days apart
Group XVI: High-Dose, 12 to <16 Years (Troponin I Testing)Experimental Treatment1 Intervention
High-Dose (30mcg), 3 doses
Group XVII: Placebo, ≥2 to <5 Years (3-dose regimen)Placebo Group1 Intervention
Group XVIII: Placebo, ≥6 Months to <2 YearsPlacebo Group1 Intervention
Group XIX: Placebo, ≥2 to <5 YearsPlacebo Group1 Intervention
Group XX: Placebo, ≥5 to <12 YearsPlacebo Group1 Intervention
Group XXI: Placebo, ≥6 Months to <2 Years (3-dose regimen)Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biological/Vaccine: BNT162b2 3mcg
2021
Completed Phase 3
~11840
Biological/Vaccine: BNT162b2 10mcg
2021
Completed Phase 3
~11840
BNT162b2 20mcg
2021
Completed Phase 3
~11840
BNT162b2 30mcg
2021
Completed Phase 3
~11840

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor
64 Previous Clinical Trials
97,344 Total Patients Enrolled
20 Trials studying COVID-19
86,732 Patients Enrolled for COVID-19
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,900,037 Total Patients Enrolled
67 Trials studying COVID-19
1,426,846 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,081,205 Total Patients Enrolled
49 Trials studying COVID-19
1,415,623 Patients Enrolled for COVID-19

Media Library

BNT162b2 (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04816643 — Phase 2 & 3
COVID-19 Research Study Groups: Placebo, ≥2 to <5 Years (3-dose regimen), Mid-Dose, ≥5 to <12 Years, High-Dose, ≥2 to <5 Years, Mid-Dose, ≥2 to <5 Years, Low/Mid-Dose, ≥5 to <12 Years, Low-Dose, ≥6 Months to <2 Years (3-dose regimen), High-Dose, ≥5 to <12 Years, Mid-Dose, ≥6 Months to <2 Years, High-Dose, ≥6 Months to <2 Years, Placebo, ≥6 Months to <2 Years, Placebo, ≥2 to <5 Years, Placebo, ≥5 to <12 Years, Low/Mid-Dose, ≥2 to < 5 Years, Low/Mid-Dose, ≥5 to <12 Years (Troponin I Testing), Low/Mid-Dose, ≥6 Months to <2 Years, Low-Dose, ≥6 Months to <2 Years, Low-Dose, ≥2 to <5 Years, High-Dose, 12 to <16 Years (Troponin I Testing), Low-Dose, ≥2 to <5 Years (3-dose regimen), Placebo, ≥6 Months to <2 Years (3-dose regimen), Placebo, ≥5 to <12 Years (Troponin I Testing)
COVID-19 Clinical Trial 2023: BNT162b2 Highlights & Side Effects. Trial Name: NCT04816643 — Phase 2 & 3
BNT162b2 (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04816643 — Phase 2 & 3

Frequently Asked Questions

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

How many test subjects are engaged in this experiment?

"Though this study was posted on March 24th, 2021 and updated September 20th, 2022, it is not currently seeking new participants. There are 1142 other trials related to covid-19 that are actively recruiting patients as well as 29 Biological/Vaccine: BNT162b2 3mcg trials."

Answered by AI

If I meet the prerequisites, can I join this research project?

"This trial is open to 10823 people aged 6 months to 18 years old who have covid-19. Eligible candidates must meet the following criteria: Male or female participants ≥6 months to <12 years of age, at the time of randomization, at Visit 1 for the dose-finding/selected-dose evaluation and for participants ≥12 to <18 years of age, at the time of randomization, at Visit 1 for the lower-dose evaluation. For the obtaining-serum-samples-for-potential-troponin I-testing portion of the study: Male or female participants between ≥"

Answered by AI

Can people who are not yet 65 years old participate in this medical research?

"The recruitment process for this trial is targeting individuals that are under 18 years old and have been living with their condition for over 6 months."

Answered by AI

Are there any patients still needed for this research?

"No, this study is not recruiting at the moment, as stated on clinicaltrials.gov. The first posting was on March 24th, 2021 and there have been subsequent updates up until September 20th, 2022. However, it's worth noting that there are 1171 other trials with open recruitment at present."

Answered by AI

Are there a lot of hospitals participating in this research project within the city limits?

"This study has 100 enrollees with locations at Emory University School of Medicine in Atlanta, Clinical Research Pickett Road in Durham, and Clinical Research Associates Inc in Nashville."

Answered by AI

Could you please list other instances where BNT162b2 3mcg has been studied?

"The BNT162b2 3mcg vaccine was first studied in 2020 at a Contract Research Organization. There have been 18301 completed clinical trials to date, with 29 active clinical trials currently underway; many of these out of Atlanta, Georgia."

Answered by AI

Has this particular clinical trial been done before?

"BioNTech SE's BNT162b2 3mcg vaccine has been under study since 2020, with the first trial completed that year. Following the initial study in 512 people, Phase 1 & 2 drug approval was given. 29 active studies involving this vaccine are being conducted across 220 cities and 27 countries."

Answered by AI

What benefits does this clinical trial hope to bring patients?

"The sponsors of this study, BioNTech SE, have stated that the main objective is to compare the percentage of participants with seroresponse in two age groups: those aged 2-5 years old and those aged 16-25 years old. This will be measured one month after receiving the second dose. Additionally, this trial will also assess secondary outcomes including immunobridging of SARS-CoV-2 serum neutralizing titers and ratio of confirmed COVID-19 illness in all age groups."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
Texas
Alabama
Other
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham - School of Medicine
Kaiser Permanente Oakland
Senders Pediatrics
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+

How responsive is this trial?

Most responsive sites:
  1. University of Alabama at Birmingham - School of Medicine: < 24 hours
Typically responds via
Email
Average response time
  • < 1 Day
Recent research and studies
New England Journal of MedicineJournal
Evaluation of the Bnt162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age
Walter, Emmanuel B., Kawsar R. Talaat, Charu Sabharwal, Alejandra Gurtman, Stephen Lockhart, Grant C. Paulsen, Elizabeth D. Barnett, et al.. 2022. “Evaluation of the Bnt162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2116298.
New England Journal of MedicineJournal
Evaluation of the Bnt162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age
Walter, Emmanuel B., Kawsar R. Talaat, Charu Sabharwal, Alejandra Gurtman, Stephen Lockhart, Grant C. Paulsen, Elizabeth D. Barnett, et al.. 2022. “Evaluation of the Bnt162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2116298.
clinicaltrials.govStudy
A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
2021. "A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04816643.
~2899 spots leftby Apr 2025
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