BNT162b2 for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
COVID-19+7 More
BNT162b2 - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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
  • Coronavirus Disease 2019 (COVID‑19)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 0 Secondary · Reporting Duration: For 7 days after Dose 1, Dose 2, Dose 3 and Dose 4

Month 1
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
Day 7
Percentage of participants reporting local reactions
Percentage of participants reporting systemic events
Month 6
Percentage of participants reporting serious adverse events
Month 1
Percentage of participants reporting adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

BNT162b2
1 of 1

Experimental Treatment

420 Total Participants · 1 Treatment Group

Primary Treatment: BNT162b2 · No Placebo Group · Phase 2

BNT162b2
Biological
Experimental Group · 1 Intervention: BNT162b2 · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pfizer-BioNTech COVID-19 Vaccine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: for 7 days after dose 1, dose 2, dose 3 and dose 4

Who is running the clinical trial?

PfizerIndustry Sponsor
4,264 Previous Clinical Trials
7,108,042 Total Patients Enrolled
46 Trials studying COVID-19
124,282 Patients Enrolled for COVID-19
BioNTech SELead Sponsor
51 Previous Clinical Trials
90,847 Total Patients Enrolled
19 Trials studying COVID-19
85,319 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,251 Previous Clinical Trials
4,823,522 Total Patients Enrolled
32 Trials studying COVID-19
114,167 Patients Enrolled for COVID-19

Eligibility Criteria

Age Any Age · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People who sign consent forms and are willing and able to comply with all the study procedures are eligible to participate in the study
The patient is expected to live at least 12 months from the time of enrollment in the investigator's opinion.
Any female participant who can have children and is willing to use a highly effective method of contraception for at least 28 days after the last dose of study intervention, if at risk of pregnancy with her/his partner; or any female participant who is not able to have children, or any male participant who is able to father children but is not willing to use a highly effective method of contraception for at least 28 days after the last dose of study intervention, if at risk of pregnancy with his/her partner.
A stable dose is defined as receiving the same dose for at least 84 days, with no changes in the 28 days prior to the first visit.
Anybody who is over the age of 18 and can be contacted by telephone is allowed to take part in this study
Male or female participants who are at least two years old at the time of enrollment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.