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Vaccine

BNT162b2 for COVID-19

Phase 2

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 for 7 days after dose 1, dose 2, dose 3 and dose 4

Awards & highlights

Study Summary

This trial will test a new 4-dose immunization schedule for people with weakened immune systems. 420 people will be enrolled from the US, Brazil, and Germany, and followed for 6 months after the 4th dose. Each participant is expected to be in the trial for about 15 months total.

Eligible Conditions

COVID-19

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for 7 days after dose 1, dose 2, dose 3 and dose 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for 7 days after dose 1, dose 2, dose 3 and dose 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and for 7 days after dose 1, dose 2, dose 3 and dose 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

GMTs of all participants, measured by SARS-CoV-2 neutralising titers, without serological or virological evidence of past SARS-CoV-2 infection and with an immunocompromised state, as specified in the protocol

Percentage of participants reporting adverse events

Percentage of participants reporting local reactions

+2 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)

Diarrhoea (DIARRHEA)

Nasopharyngitis

Headache

Pyrexia

Pneumonia

Ovarian neoplasm

100%

80%

60%

40%

20%

Study treatment Arm

BNT162b2

Placebo

Placebo Then BNT162b2

Trial Design

1Treatment groups

Experimental Treatment

Group I: BNT162b2Experimental Treatment1 Intervention

Intramuscular Injection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BNT162b2

2021

Completed Phase 4

~91740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor

64 Previous Clinical Trials

109,057 Total Patients Enrolled

20 Trials studying COVID-19

98,445 Patients Enrolled for COVID-19

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,750 Total Patients Enrolled

67 Trials studying COVID-19

1,438,559 Patients Enrolled for COVID-19

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,092,918 Total Patients Enrolled

49 Trials studying COVID-19

1,427,336 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 we currently able to enroll anyone in this experiment?

"Currently, this study is looking for participants and according to the clinicaltrials.gov website, recruitment is still open. The trial was posted on October 15th, 2021 with the most recent update coming on October 12th of next year."

Answered by AI

What is the FDA's decision on BNT162b2?

"While Phase 2 trials don't have data supporting efficacy, BNT162b2's safety was evaluated to be a 2."

Answered by AI

Is this medical experiment the first to test this drug's effects?

"As of now, 29 clinical trials for BNT162b2 are ongoing in 220 cities and 27 countries. The first trial occurred in 2020 and was completed by 512 patients. So far, 17 different Phase 1 & 2 approvals have been given since the start of the original study."

Answered by AI

Are there different research facilities across the country conducting this same experiment?

"The current study has a total of 12 participating locations, these include: Seattle Children's Research Institute: Building Cure in Seattle, Seattle Children's Hospital in Jefferson and Cincinnati Children's Hospital in Detroit."

Answered by AI

To your knowledge, what other scientific investigations have utilized BNT162b2?

"Currently, there are 7 Phase 3 trials and 29 clinical trials in total for BNT162b2. The global study is being conducted at 775 different medical centres, with several of them located in Roskilde and Aarhus N."

Answered by AI

How many people will be given the opportunity to participate in this research project?

"In order for this clinical trial to move forward, researchers need 420 patients that match the pre-specified inclusion criteria. Currently, there are two locations where potential participants can go: Seattle Children's Research Institute in Seattle, Washington and Seattle Children's Hospital located in Jefferson, Louisiana."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years

2021. "Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04895982.