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A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

Primary Purpose

SARS-CoV-2 Infection, COVID-19

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BNT162b5 Bivalent (WT/OMI BA.2)

BNT162b2 Bivalent (WT/OMI BA.1)

BNT162b2 Bivalent (WT/OMI BA.4/BA.5)

BNT162b5 Bivalent (Original/OMI BA.4/BA.5)

BNT162b6 Bivalent (Original/OMI BA.4/BA.5)

BNT162b7 Bivalent (Original/OMI BA.4/BA.5)

BNT162b7 Monovalent (OMI BA.4/BA.5)

About this trial

This is an interventional prevention trial for SARS-CoV-2 Infection focused on measuring SARS-CoV-2 infection, COVID-19

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Cohort 1: 18 through 55 years of age.
Cohort 2: 12 years of age and older.
Cohort 3: 18 years of age and older.
All Cohorts:

Healthy participants (stable pre-existing disease permitted).

Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
Capable of giving signed informed consent.

Cohort 1:

- Received of 1 booster dose of a US-authorized COVID-19 vaccine, with the dose being 90 or more days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.

Cohorts 2 and 3:

- Received 3 prior doses of 30 micrograms BNT162b2, with last dose being 150 to 365 days before first study visit.

Exclusion Criteria:

All Cohorts:

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
Known or suspected immunodeficiency.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Cohorts 1 and 2:

Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study.
Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study.

Cohort 3:

Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study.
Participation in other studies involving receipt of a study intervention within 28 days before randomization. Anticipated participation in other studies involving a study intervention from randomization through the end of this study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2)

Cohort 1: BNT162b2 Bivalent (WT/OMI BA.1)

Cohort 2 -Group 1: 12-17 years; 30 µg

Cohort 2 - Group 2: 18-55 years; 30 µg

Cohort 2 - Group 3: 18-55 years; 60 µg

Cohort 2 - Group 4: >55 years; 30 µg

Cohort 2 - Group 5: >55 years; 60 µg

Cohort 3 - Group 1: 18-55 years; 30 µg

Cohort 3 - Group 2: >55 years; 30 µg

Cohort 4: BNT162b2 Bivalent (Original/OMI BA.4/BA.5)

Cohort 4: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)

Cohort 4: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)

Cohort 4: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)

Cohort 4: BNT162b7 Monovalent (OMI BA.4/BA.5)

Arm Description

Participants will receive 30 µg of BNT162b5 Bivalent (WT/OMI BA.2) at Visit 1.

Participants will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.1) at Visit 1.

Participants 12-17 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Participants 18-55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Participants 18-55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Participants over 55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Participants over 55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.

Participants will receive 30 µg of BNT162b2 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Participants will receive 30 µg of BNT162b5 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Participants will receive 30 µg of BNT162b6 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Participants will receive 30 µg of BNT162b7 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Participants will receive 30 µg of BNT162b7 Monovalent (OMI BA.4/BA.5) at Visit 1

Outcomes

Primary Outcome Measures

All Cohorts: Percentage of participants reporting local reactions

Pain at the injection site, redness, and swelling, as self-reported in electronic diaries

All Cohorts: Percentage of participants reporting systemic events

Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries

All Cohorts: Percentage of participants reporting adverse events

As elicited by the investigational staff

All Cohorts: Percentage of participants reporting serious adverse events

As elicited by the investigational staff

Cohort 1: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg

As measured at the central laboratory.

Cohort 1: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg.

As measured at the central laboratory.

Cohort 1: Percentages of participants with seroresponse to BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels.

As measured at the central laboratory.

Cohort 2: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg or 60 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg or 60 µg

As measured at the central laboratory.

Cohort 2: GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg or 60 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg or 60 µg..

As measured at the central laboratory.

Cohort 2: % of participants with seroresponse to BNT162b2 Bivalent(WT/OMI BA.4/BA.5) 30µg or 60µg and BNT162b2 Bivalent(WT/OMI BA.1) 30µg or 60µg for GMTs of SARS-CoV-2 Omicron(BA.4/BA.5), Omicron(BA.1), and reference strain neutralizing antibody levels.

As measured at the central laboratory.

Cohorts 2+3 (>55 yrs) Superiority analysis: Geometric Mean Ratio (GMR) of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg to BNT162b2 30 μg (C4591031 Substudy E).

As measured at the central laboratory.

Cohorts 2+3 (>55 yrs) Noninferiority analysis: Differences in %s of participants with seroresponse to SARS-CoV-2 Omicron BA.4/BA.5 after vaccination with BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg or BNT162b2 30 μg (C4591031 Substudy E).

As measured at the central laboratory.

Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs) Noninferiority analysis: GMR of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg in participants 18-55 yrs compared to participants >55 yrs.

As measured at the central laboratory.

Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs) Noninferiority analysis: Differences in %s of pts with seroresponse to SARS-CoV-2 Omicron BA.4/BA.5 after vaccination with BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg in pts 18-55 yrs compared to pts >55 yrs.

As measured at the central laboratory.

Cohort 4: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent

As measured at the central laboratory

Cohort 4: GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent

As measured at the central laboratory

Cohort 4: % of participants with seroresponse to 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent for GMTs of SARS-CoV-2 Omicron(BA.4/BA.5), and reference strain neutralizing antibody levels

As measured at the central laboratory

Secondary Outcome Measures

Cohorts 2+3 (>55 yrs) Noninferiority analysis: GMR of SARS-CoV-2 reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg to BNT162b2 30 μg (C4591031 Substudy E).

As measured at the central laboratory.

Cohorts 2+3 (18-55 yrs), Cohorts 2+3 (>55 yrs): GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E).

As measured at the central laboratory.

Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E).

As measured at the central laboratory.

Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): % of participants with seroresponse to BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 SSE) for GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels.

As measured at the central laboratory.

Full Information

NCT ID

NCT05472038

First Posted

July 15, 2022

Last Updated

October 23, 2023

Sponsor

BioNTech SE

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT05472038

Brief Title

A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

Official Title

AN INTERVENTIONAL, RANDOMIZED, ACTIVE-CONTROLLED, PHASE 1/2/3 STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b RNA-BASED VACCINE CANDIDATES IN COVID-19 VACCINE-EXPERIENCED HEALTHY INDIVIDUALS

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 26, 2022 (Actual)

Primary Completion Date

March 19, 2024 (Anticipated)

Study Completion Date

March 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioNTech SE

Collaborators

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19. For all cohorts (groups of participants), this study is seeking participants who are healthy (who may have preexisting disease if it is stable); All participants will receive a single dose of the study vaccine at the first study clinic and will return to the study clinic at least 4 more times. At each clinic visit, a blood sample will be taken. The study is about 6 months long for each participant. The vaccine candidates in this study are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries. For Cohort 1, this study included participants who were: 18 through 55 years of age have received 1 booster dose of a US-authorized COVID-19 vaccine, with the last dose being 90 or more days before Visit 1 of this study. All participants in Cohort 1 will receive 1 of the 2 study vaccines at a 30 microgram dose: BNT162b5 Bivalent (WT/OMI BA.2) or BNT162b2 Bivalent (WT/OMI BA.1). For Cohort 2, this study included participants who were: 12 years of age and older have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study. Participants 12 through 17 years of age will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms. Participants 18 years and older will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at either a 30 microgram or a 60 microgram dose. For Cohort 3, this study included participants who were: 18 years of age and older have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study. Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms. For Cohort 4, this study is seeking participants who are: 18 through 55 years of age have received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized BA.4/BA.5-adapted bivalent vaccine and dose level at least 150 days before Visit 1 of this study. All participants in Cohort 4 will receive 1 of the 5 study vaccines at a 30 microgram dose: BNT162b2 Bivalent (Original/ OMI BA.4/BA.5), BNT162b5 Bivalent (Original/OMI BA.4/BA.5), BNT162b6 Bivalent (Original/OMI BA.4/BA.5), BNT162b7 Bivalent (Original/OMI BA.4/BA.5) or BNT162b7 Monovalent (OMI BA.4/BA.5).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV-2 Infection, COVID-19

Keywords

SARS-CoV-2 infection, COVID-19

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Phase 1/2/3, randomized, active-controlled, parallel group study.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Cohort 1 and Cohort 2 (18 years and older): Observer-blind Cohort 2 (12-17 years) and Cohort 3: Open-label Cohort 4: Observer-blind

Allocation

Randomized

Enrollment

1424 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2)

Arm Type

Experimental

Arm Description

Participants will receive 30 µg of BNT162b5 Bivalent (WT/OMI BA.2) at Visit 1.

Arm Title

Cohort 1: BNT162b2 Bivalent (WT/OMI BA.1)

Arm Type

Experimental

Arm Description

Participants will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.1) at Visit 1.

Arm Title

Cohort 2 -Group 1: 12-17 years; 30 µg

Arm Type

Experimental

Arm Description

Participants 12-17 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Arm Title

Cohort 2 - Group 2: 18-55 years; 30 µg

Arm Type

Experimental

Arm Description

Participants 18-55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Arm Title

Cohort 2 - Group 3: 18-55 years; 60 µg

Arm Type

Experimental

Arm Description

Participants 18-55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Arm Title

Cohort 2 - Group 4: >55 years; 30 µg

Arm Type

Experimental

Arm Description

Participants over 55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Arm Title

Cohort 2 - Group 5: >55 years; 60 µg

Arm Type

Experimental

Arm Description

Participants over 55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Arm Title

Cohort 3 - Group 1: 18-55 years; 30 µg

Arm Type

Experimental

Arm Description

Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.

Arm Title

Cohort 3 - Group 2: >55 years; 30 µg

Arm Type

Experimental

Arm Description

Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.

Arm Title

Cohort 4: BNT162b2 Bivalent (Original/OMI BA.4/BA.5)

Arm Type

Active Comparator

Arm Description

Participants will receive 30 µg of BNT162b2 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Arm Title

Cohort 4: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)

Arm Type

Experimental

Arm Description

Participants will receive 30 µg of BNT162b5 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Arm Title

Cohort 4: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)

Arm Type

Experimental

Arm Description

Participants will receive 30 µg of BNT162b6 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Arm Title

Cohort 4: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)

Arm Type

Experimental

Arm Description

Participants will receive 30 µg of BNT162b7 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Arm Title

Cohort 4: BNT162b7 Monovalent (OMI BA.4/BA.5)

Arm Type

Experimental

Arm Description

Participants will receive 30 µg of BNT162b7 Monovalent (OMI BA.4/BA.5) at Visit 1

Intervention Type

Biological

Intervention Name(s)

BNT162b5 Bivalent (WT/OMI BA.2)

Intervention Description

BNT162b5 Wild Type and BNT162b5 OMICRON [B.1.1.529 sublineage BA.2]

Intervention Type

Biological

Intervention Name(s)

BNT162b2 Bivalent (WT/OMI BA.1)

Intervention Description

BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.1]

Intervention Type

Biological

Intervention Name(s)

BNT162b2 Bivalent (WT/OMI BA.4/BA.5)

Intervention Description

BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.4/BA.5]

Intervention Type

Biological

Intervention Name(s)

BNT162b5 Bivalent (Original/OMI BA.4/BA.5)

Intervention Description

BNT162b5 Wild Type and BNT162b5 OMICRON [B.1.1.529 sublineage BA.4/BA.5]

Intervention Type

Biological

Intervention Name(s)

BNT162b6 Bivalent (Original/OMI BA.4/BA.5)

Intervention Description

BNT162b6 Wild Type and BNT162b6 OMICRON [B.1.1.529 sublineage BA.4/BA.5]

Intervention Type

Biological

Intervention Name(s)

BNT162b7 Bivalent (Original/OMI BA.4/BA.5)

Intervention Description

BNT162b7 Wild Type and BNT162b7 OMICRON [B.1.1.529 sublineage BA.4/BA.5]

Intervention Type

Biological

Intervention Name(s)

BNT162b7 Monovalent (OMI BA.4/BA.5)

Intervention Description

BNT162b7 OMICRON [B.1.1.529 sublineage BA.4/BA.5]

Primary Outcome Measure Information:

Title

All Cohorts: Percentage of participants reporting local reactions

Description

Pain at the injection site, redness, and swelling, as self-reported in electronic diaries

Time Frame

For 7 days following the study vaccination

Title

All Cohorts: Percentage of participants reporting systemic events

Description

Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries

Time Frame

For 7 days following the study vaccination

Title

All Cohorts: Percentage of participants reporting adverse events

Description

As elicited by the investigational staff

Time Frame

For 1 month following the study vaccination

Title

All Cohorts: Percentage of participants reporting serious adverse events

Description

As elicited by the investigational staff

Time Frame

For 6 months following the study vaccination

Title

Description

As measured at the central laboratory.

Time Frame

Before study vaccination (Day 1).

Title

Description

As measured at the central laboratory.

Time Frame

At 1 month after study vaccination.

Title

Description

As measured at the central laboratory.

Time Frame

From before study vaccination (Day 1) to 1 month after study vaccination.

Title

Description

As measured at the central laboratory.

Time Frame

At 1 month after study vaccination.

Title

Description

As measured at the central laboratory.

Time Frame

Before study vaccination (Day 1).

Title

Description

As measured at the central laboratory.

Time Frame

At 1 month after study vaccination.

Title

Description

As measured at the central laboratory.

Time Frame

From before study vaccination (Day 1) to 1 month after study vaccination.

Title

Description

As measured at the central laboratory.

Time Frame

At 1 month after study vaccination

Title

Description

As measured at the central laboratory.

Time Frame

At 1 month after study vaccination.

Title

Description

As measured at the central laboratory.

Time Frame

At 1 month after study vaccination.

Title

Description

As measured at the central laboratory.

Time Frame

At 1 month after study vaccination.

Title

Description

As measured at the central laboratory.

Time Frame

At 1 month after study vaccination.

Title

Description

As measured at the central laboratory

Time Frame

Before study vaccination (Day 1)

Title

Description

As measured at the central laboratory

Time Frame

At 1 month after study vaccination

Title

Description

As measured at the central laboratory

Time Frame

From before study vaccination (Day 1) to 1 month after study vaccination.

Title

Description

As measured at the central laboratory

Time Frame

At 1 month after study vaccination

Secondary Outcome Measure Information:

Title

Description

As measured at the central laboratory.

Time Frame

At 1 month after study vaccination.

Title

Description

As measured at the central laboratory.

Time Frame

Before study vaccination (Day 1).

Title

Description

As measured at the central laboratory.

Time Frame

At 1 month after study vaccination.

Title

Description

As measured at the central laboratory.

Time Frame

From before study vaccination (Day 1) to 1 month after study vaccination.

Title

Description

As measured at the central laboratory.

Time Frame

At 1 month after study vaccination.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: Cohort 1: 18 through 55 years of age. Cohort 2: 12 years of age and older. Cohort 3: 18 years of age and older. Cohort 4: 18 through 55 years of age. Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations. Healthy participants (stable pre-existing disease permitted). Capable of giving signed informed consent. Prior COVID-19 vaccination history: Cohort 1: - Received of 1 booster dose of a US-authorized COVID-19 vaccine, with the dose being 90 or more days before first study visit. Documented receipt of all prior COVID-19 vaccines is required. Cohorts 2 and 3: - Received 3 prior doses of 30 micrograms BNT162b2, with last dose being 150 to 365 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required. Cohort 4: - Received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized Omicron BA.4/BA.5-adapted vaccine and dose level at least 150 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required. Exclusion Criteria: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. Known or suspected immunodeficiency. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. Women who are pregnant or breastfeeding. Other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Immunosuppressants/radiotherapy: Cohorts 1 and 2: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. Cohorts 3 and 4: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. Blood/plasma products, immunoglobulin, or monoclonal antibodies: Cohorts 1, 2, 3: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study. Cohort 4: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for treatment/prevention of COVID-19 or those considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study. Other study participation: Cohorts 1 and 2: Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study. Cohorts 3 and 4: Participation in other studies involving receipt of a study intervention within 28 days before randomization. Anticipated participation in other studies involving a study intervention from randomization through the end of this study. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. Cohort 4 only: History of myocarditis or pericarditis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Anaheim Clinical Trials, LLC

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

California Research Foundation

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Bayview Research Group, LLC

City

Valley Village

State/Province

California

ZIP/Postal Code

91607

Country

United States

Facility Name

Diablo Clinical Research, Inc.

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Clinical Research Consulting

City

Milford

State/Province

Connecticut

ZIP/Postal Code

06460

Country

United States

Facility Name

Research Centers of America ( Hollywood )

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Acevedo Clinical Research Associates

City

Miami

State/Province

Florida

ZIP/Postal Code

33142

Country

United States

Facility Name

Clinical Research Atlanta

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

East-West Medical Research Institute

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Kentucky Pediatric/ Adult Research

City

Bardstown

State/Province

Kentucky

ZIP/Postal Code

40004

Country

United States

Facility Name

Clinical Research Professionals

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63005

Country

United States

Facility Name

Sundance Clinical Research

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Velocity Clinical Research, Omaha

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

South Jersey Infectious Disease

City

Somers Point

State/Province

New Jersey

ZIP/Postal Code

08244

Country

United States

Facility Name

Rochester Clinical Research, LLC

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Accellacare - Charlotte

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

Accellacare - Charlotte

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28211

Country

United States

Facility Name

PharmQuest Life Sciences, LLC

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Accellacare - Wilmington

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Senders Pediatrics

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44121

Country

United States

Facility Name

Centricity Research Columbus Ohio Multispecialty

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Kaiser Permanente Northwest Center for Health Research

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Clinical Neuroscience Solutions Inc.

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Benchmark Research

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Tekton Research, LLC.

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

DM Clinical Research - Bellaire

City

Houston

State/Province

Texas

ZIP/Postal Code

77081

Country

United States

Facility Name

IMA Clinical Research San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

DM Clinical Research

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

J. Lewis Research, Inc. / Foothill Family Clinic

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

J. Lewis Research, Inc. / Foothill Family Clinic South

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

Facility Name

Virginia Research Center

City

Midlothian

State/Province

Virginia

ZIP/Postal Code

23114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=C4591044

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

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A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

SARS-CoV-2 Infection, COVID-19

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial