1051 Participants Needed

BNT162b2 Vaccine for COVID-19

Recruiting at 40 trial locations
PC
Overseen ByPfizer CT.gov Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.Substudy A:* This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, * in people who are 12 years of age and older, * who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1).* The study is about 6 months long for each participant.* Participants will have at least 5 visits to the clinic.* At each clinic visit a blood sample will be taken.* At least 1 nasal swab will taken.Substudy B:* This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, * in people who are 12 years of age and older, * who are COVID-19 vaccine-naïve * who have had any positive SARS-CoV-2 test result \>28 days before study vaccine administration.* The study is about 6 months long for each participant.* Participants will have at least 5 visits to the clinic.* At each clinic visit a blood sample will be taken.* At least 1 nasal swab will taken.Substudy C:* This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to: * Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and, * Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and, * Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2). * Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the study vaccination (Visit 1).* The study is about 6 months long for each participant.* Participants will have at least 6 visits (Cohorts 1 and 3) or at least 5 visits (Cohort 2) to the clinic.* At each clinic visit a blood sample will be taken.* At least 1 nasal swab will taken.

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 12 and older. Substudy A includes those who've had at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the last being an Omicron BA.4/BA.5-adapted bivalent vaccine over 150 days ago. Substudy B is for COVID-19 vaccine-naïve people who tested positive for SARS-CoV-2 more than 28 days before.

Inclusion Criteria

I am generally healthy, even if I have a stable, pre-existing condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single 30 µg dose of BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and immunogenicity, with blood samples and nasal swabs taken at each visit

6 months
At least 5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • BNT162b2 (Omi XBB.1.5)
Trial Overview The study tests a new RNA-based COVID-19 vaccine candidate, BNT162b2 (Omi XBB.1.5), targeting recent variants as a single dose to evaluate safety and immune response over about six months with at least five clinic visits involving blood samples and nasal swabs.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: SSC: Group 4Experimental Treatment1 Intervention
Group II: SSC: Group 3Experimental Treatment1 Intervention
Group III: SSC - Group 5Experimental Treatment1 Intervention
Group IV: SSB: Group 2Experimental Treatment1 Intervention
Group V: SSA: Group 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials
84
Recruited
120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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