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Vaccine

BNT162b2 for COVID-19

Phase 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and 3 days after study vaccination
Awards & highlights

Study Summary

This trial will assess the safety and efficacy of a booster dose of the BNT162b2 vaccine in adults who have received 2 doses of the vaccine at least 6 months prior. The trial will also assess the safety and tolerability of a single dose of the BNT162b2 vaccine in adolescents 12-17 years of age, as compared to a placebo control.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and 3 days after study vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and 3 days after study vaccination 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 - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection
SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection
SSA - Percentage of participants reporting adverse events
+37 more
Secondary outcome measures
SSA - Confirmed severe COVID-19 (based on CDC definition) in participants with and without evidence of past SARS-CoV-2 infection
SSA - Confirmed severe COVID-19 (based on CDC definition) in participants without evidence of past SARS-CoV-2 infection
SSA - Confirmed severe COVID-19 (based on FDA definition) in participants with and without evidence of past SARS-CoV-2 infection
+13 more

Side effects data

From 2021 Phase 4 trial • 160 Patients • NCT04588480
92%
Injection site pain (PAIN)
63%
Fatigue (FATIGUE)
54%
Headache (HEADACHE)
49%
Chills (CHILLS)
36%
Pyrexia (FEVER)
29%
Arthralgia (JOINT PAIN)
24%
Myalgia (MUSCLE PAIN)
19%
Injection site erythema (REDNESS)
16%
Injection site swelling (SWELLING)
8%
Diarrhoea (DIARRHEA)
3%
Nasopharyngitis
2%
Headache
1%
Pyrexia
1%
Pneumonia
1%
Ovarian neoplasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
BNT162b2
Placebo
Placebo Then BNT162b2

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 60 µg doseExperimental Treatment4 Interventions
1 dose
Group II: 30 µg doseExperimental Treatment4 Interventions
1 dose
Group III: 10 µg doseExperimental Treatment1 Intervention
1 dose
Group IV: PlaceboPlacebo Group1 Intervention
1 dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Combination BNT162b2 and BNT162b2 OMI
2021
Completed Phase 3
~16390
BNT162b2
2021
Completed Phase 4
~91740
BNT162b2 OMI
2021
Completed Phase 3
~16390
Combination (Bivalent) BNT162b2 and BNT162b2 OMI
2021
Completed Phase 3
~16390

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,895,488 Total Patients Enrolled
67 Trials studying COVID-19
1,422,298 Patients Enrolled for COVID-19
BioNTech SELead Sponsor
64 Previous Clinical Trials
92,796 Total Patients Enrolled
20 Trials studying COVID-19
82,184 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,076,656 Total Patients Enrolled
49 Trials studying COVID-19
1,411,075 Patients Enrolled for COVID-19

Frequently Asked Questions

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

Are researchers still looking for participants in this trial?

"No, this specific research project is no longer recruiting patients according to the latest information from clinicaltrials.gov. This trial was first posted on July 1st, 2021 but has not been updated since November 2nd, 2022. There are 1171 other trials that are still open and looking for participants."

Answered by AI

At how many hospitals or research centers is this clinical trial taking place?

"There are 59 clinical trial sites currently running this study, including M3 Wake Research, Inc. in Raleigh, Wake Research - Clinical Research Center of Nevada in Las Vegas, and Clinical Neuroscience Solutions, Inc in Memphis."

Answered by AI

Is there a high efficacy rate for BNT162b2?

"There is some data that suggests BNT162b2 is effective, and it has undergone multiple rounds of testing to prove its safety, so our team at Power rates it a 3."

Answered by AI

How many test subjects are participating in this experiment?

"Presently, this study is not enrolling new patients. The trial was first hosted on July 1st 2021 and last updated November 2nd 2022. There are 1142 other studies seeking patients with covid-19 and 29 trials for BNT162b2 that are currently admitting patients."

Answered by AI

Does this research break new ground in the medical field?

"BNT162b2 has been researched since 2020. The earliest trial occurred in 2020 and was sponsored by BioNTech SE. Following the first study in 2020, which involved 512 patients, BNT162b2 received its Phase 1 & 2 drug approval. Today there are 29 live trials for BNT162b2 across 220 cities and 27 countries."

Answered by AI

What other vaccine research studies has BNT162b2 been used in?

"Currently, there are 29 trials underway for BNT162b2. Of those, 7 are in Phase 3. Although the majority of studies for BNT162b2 are based in Roskilde and Aarhus N, there are 775 total locations running these trials."

Answered by AI

What are the goals of this medical experiment?

"The primary outcome of this study will be the SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 2 doses BNT162b2 OMI compared to after 2 doses BNT162b2 in participants from the C4591001 study, evaluated over a At baseline (before the third dose), 1 month and 6 months after the third dose time frame. Secondary outcomes include SSD - The noninferiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI"

Answered by AI

Who else is applying?

What state do they live in?
Florida
Nevada
Other
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Clinical Research Consulting
Center for Immunization Research Inpatient Unit
Texas Center for Drug Development, Inc.
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Alliance for Multispecialty Research, LLC: < 24 hours
  2. Meridian Clinical Research, LLC: < 24 hours
  3. Texas Center for Drug Development, Inc.: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
New England Journal of MedicineJournal
Safety and Efficacy of a Third Dose of Bnt162b2 Covid-19 Vaccine
Moreira, Edson D., Jr., Nicholas Kitchin, Xia Xu, Samuel S. Dychter, Stephen Lockhart, Alejandra Gurtman, John L. Perez, et al.. 2022. “Safety and Efficacy of a Third Dose of Bnt162b2 Covid-19 Vaccine”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2200674.
New England Journal of MedicineJournal
Safety and Efficacy of a Third Dose of Bnt162b2 Covid-19 Vaccine
Moreira, Edson D., Jr., Nicholas Kitchin, Xia Xu, Samuel S. Dychter, Stephen Lockhart, Alejandra Gurtman, John L. Perez, et al.. 2022. “Safety and Efficacy of a Third Dose of Bnt162b2 Covid-19 Vaccine”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2200674.
clinicaltrials.govStudy
To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.
2021. "To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04955626.
~4369 spots leftby Apr 2025
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