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A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

NCT05997290 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1051

Last updated 2026-04-28

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

BNT162b2 (Omi XBB.1.5)

BNT162b2 monovalent (Omicron XBB.1.5)

BIOLOGICAL

BNT162b2 (Omi JN.1)

BNT162b2 monovalent (Omicron JN.1)

BIOLOGICAL

BNT162b2 (Omi KP.2)

BNT162b2 monovalent (Omicron KP.2)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2025-03-13
Completion
2025-03-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05997290 on ClinicalTrials.gov