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AzTrials

Influenza, HumanPhase 2NCT05596734

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza

A Phase 2 study testing bivalent BNT162b2 (original/Omi BA.4/BA.5), qIRV (22/23) and QIV in people with Influenza, Human and COVID-19, run by BioNTech SE at 59 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Human, COVID-19
What is being tested?
bivalent BNT162b2 (original/Omi BA.4/BA.5), qIRV (22/23) and QIV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,019 participants
Where
59 sitesUnited States
Study dates
28 Oct 2022to 28 Dec 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

SSA: Inclusion Criteria:

  • Male or female participants 18 years of age and older
  • Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Capable of giving signed informed consent as described in the protocol.
  • For participants 18 through 64 years of age: participants who have received 3 prior doses of 30 µg BNT162b2, with the last dose being 150 to 365 days before Visit 1 (Day 1).
  • For participants 65 years of age and older: participants who have received 4 or 5 prior doses of a modRNA SARS-CoV-2 vaccine, with the last dose being a bivalent vaccine, 120 days to 365 days before Visit 1 (Day 1).
  • For Participants 65 years of age and older: receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season 120 days or more before study intervention administration.

SSA: Exclusion Criteria:

  • History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  • Immunocompromised individuals with known or suspected immunodeficiency.
  • Bleeding diathesis or condition associated with prolonged bleeding.
  • Women who are pregnant or breastfeeding.
  • Allergy to egg proteins (egg or egg products) or chicken proteins.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior 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 chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study.
  • Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
  • For participants 18 through 64 years of age: vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration.
  • 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.
  • 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.
  • Participation in strenuous or endurance exercise through Visit 3 of the study.
  • Prior history of heart disease.
  • Any abnormal screening troponin I laboratory value.
  • Screening 12-lead ECG that, as judged by the investigator, is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.

SSB: Inclusion Criteria

  • Male or female participants 18 years of age and older
  • Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Capable of giving signed informed consent as described in the protocol.
  • Participants who have received at least 3 prior US-authorized mRNA COVID-19 vaccines, with the last dose being an updated (bivalent) vaccine given at least 150 days before Day 1.

SSB: Exclusion Criteria

  • Medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
  • Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study.
  • Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
  • Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza
  • Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in 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.
  • Initial enrollment only: Participation in strenuous or endurance exercise through Visit 3 (initial enrollment phase).
  • Initial enrollment only: Prior history of heart disease of concern
  • Initial enrollment only: Screening 12-lead ECG that, as judged by the investigator, is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • North Alabama Research Center

    Athens, Alabama, 35611

  • The Heart Center

    Athens, Alabama, 35611

  • Pradeep Chandra, DO, FACC

    Bridgeton, Missouri, 63044

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60640

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818

  • Retina Associates

    Elmhurst, Illinois, 60126

  • Michigan Center of Medical Research (MICHMER)

    Farmington Hills, Michigan, 48334

  • Proactive Clinical Research,LLC

    Fort Lauderdale, Florida, 33308

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Finlay Medical Research

    Greenacres City, Florida, 33467

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • Research Centers of America ( Hollywood )

    Hollywood, Florida, 33024

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37909

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37920

  • Orange County Research Center

    Lake Forest, California, 92630

  • Pioneer Heart Institute

    Lincoln, Nebraska, 68506

  • Main Street Physician's Care

    Little River, South Carolina, 29566

  • McLeod Cardiology Associates - Little River

    Little River, South Carolina, 29566

  • Angels Clinical Research Institute

    Miami, Florida, 33122

  • Miami Clinical Research

    Miami, Florida, 33155

  • Gerardo Polanco, MD

    Miami, Florida, 33156

  • Research Institute of South Florida

    Miami, Florida, 33173

  • Entrust Clinical Research

    Miami, Florida, 33176

  • Jackson Medical Group Cardiac Care

    Miami, Florida, 33176

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176

  • Palm Springs Community Health Center

    Miami Lakes, Florida, 33014

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Palm Springs Community Health Center

    Miami Lakes, Florida, 33016

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Affinity Health

    Oak Brook, Illinois, 60523

  • Alliance for Multispecialty Research, LLC

    Oak Brook, Illinois, 60523

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134

  • Orange County Heart Institute

    Orange, California, 92868

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • DBC Research USA

    Pembroke Pines, Florida, 33029

  • HOPE Research Institute

    Phoenix, Arizona, 85018

  • The Pain Center of Arizona

    Phoenix, Arizona, 85018

  • United Medical Research

    Port Orange, Florida, 32127

  • ActivMed Practices & Research, LLC.

    Portsmouth, New Hampshire, 03801

  • M3 Wake Research, Inc.

    Raleigh, North Carolina, 27612

  • California Research Foundation

    San Diego, California, 92123

  • Velocity Clinical Research, Savannah

    Savannah, Georgia, 31406

  • Savannah Medical Group

    Savannah, Georgia, 31419

  • Jadestone Clinical Research

    Silver Spring, Maryland, 20904

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • SUNY Upstate Medical University Institute for Global Health

    Syracuse, New York, 13215

  • DM Clinical Research, Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • DM Clinical Research

    Tomball, Texas, 77375

  • Orange County Research Center

    Tustin, California, 92780

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED MODIFIED RNA VACCINE CANDIDATES AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS

Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either:

  • qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations
  • qIRV (22/23) at dose level 1,
  • qIRV (22/23) at dose level 2, or
  • bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV).

Substudy B: This Phase 1/2 study will describe the safety, tolerability, and immunogenicity of quadrivalent influenza vaccine (qIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), trivalent influenza vaccine (tIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), and bivalent influenza vaccine (bIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5) when given concurrently with licensed quadrivalent influenza vaccine (QIV).

Being tested
bivalent BNT162b2 (original/Omi BA.4/BA.5), qIRV (22/23), QIV, bIRV, tIRV
Keywords
SARS-Cov-2, COVID-19, Influenza, Grippe, Flu, Vaccine, RNA vaccine
Medical subject headings
Influenza, Human, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bivalent BNT162b2 (original/Omi BA.4/BA.5)Biological

    Intramuscular injection

  • qIRV (22/23)Biological

    Intramuscular injection

  • QIVBiological

    Intramuscular injection

  • bIRVBiological

    Intramuscular injection

  • tIRVBiological

    Intramuscular injection

Study groups in NCT05596734
Study groupRoleWhat they receive
SSA: qIRV + bivalent BNT162b2 (dose level combination 1)ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)
SSA: qIRV + bivalent BNT162b2 (dose level combination 2)ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)
SSA: qIRV + bivalent BNT162b2 (dose level combination 3)ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)
SSA: qIRV (dose level 1)ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: qIRV (22/23)
SSA: qIRV (dose level 2)ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: qIRV (22/23)
SSA: bivalent BNT162b2 (dose level 1) + QIVExperimentalBNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: QIV
SSB: QIV + bivalent BNT162b2 (original/Omi BA.4/BA.5)ExperimentalBNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: QIV
SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5)ExperimentalBNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: QIV; Biological: bIRV
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 1ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 2ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 3ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 4ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 5ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 6ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 7ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 8ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)
SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5)ExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: tIRV
SSB: qIRVExperimentalAdministered intramuscularly into the deltoid muscle of the right arm
Receives: Biological: qIRV (22/23)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years)

    Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild (Grade 1): greater than (>) 2.0 cm to 5.0 cm; moderate (Grade 2): >5.0 cm to 10.0 cm; severe (Grade 3): >10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.

    Measured: SSA: From Day 1 to Day 7 after Vaccination

  2. SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years)

    Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): >2.0 cm to 5.0 cm; moderate (Grade 2): >5.0 cm to 10.0 cm; severe (Grade 3): >10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.

    Measured: SSA: From Day 1 to Day 7 after Vaccination

  3. SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years)

    Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature >=38.0 deg C and categorized as>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: >2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h.Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.

    Measured: SSA: From Day 1 to Day 7 after Vaccination

  4. SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years)

    Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature >=38.0 deg C and categorized as>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: >2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h.Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.

    Measured: SSA: From Day 1 to Day 7 after Vaccination

  5. SSA: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years)

    An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.

    Measured: SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination

  6. SSA: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years)

    An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.

    Measured: SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination

  7. SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years)

    An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.

    Measured: SSA: From Vaccination on Day 1 through 6 Months after Vaccination

  8. SSA: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years)

    An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.

    Measured: SSA: From Vaccination on Day 1 through 6 Months after Vaccination

  9. SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years)

    An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.

    Measured: SSA: 2 Days after Vaccination

  10. SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years)

    An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.

    Measured: SSA: 2 Days after Vaccination

  11. SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years)

    An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.

    Measured: SSA: 1 Week After Vaccination

  12. SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years)

    An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.

    Measured: SSA: 1 Week After Vaccination

  13. SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years)

    An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

    Measured: SSA: 2 Days after Vaccination

  14. SSA: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years)

    An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

    Measured: SSA: 2 Days after Vaccination

  15. SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years)

    An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

    Measured: SSA: 1 Week after Vaccination

  16. SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years)

    An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

    Measured: SSA: 1 Week after Vaccination

  17. SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years)

    An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.

    Measured: SSB: 2 Days after Vaccination

  18. SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years)

    An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.

    Measured: SSB: 1 Week after Vaccination

  19. SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years)

    An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

    Measured: SSB: 2 Days after Vaccination

  20. SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years)

    An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

    Measured: SSB: 1 Week after Vaccination

  21. SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years)

    Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): >2.0 cm to 5.0 cm; moderate (Grade 2): >5.0 cm to 10.0 cm; severe (Grade 3): >10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.

    Measured: SSB: From Day 1 to Day 7 after Vaccination

  22. SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years)

    Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature >=38.0 deg C and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: >2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.

    Measured: SSB: From Day 1 to Day 7 after Vaccination

  23. SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years)

    An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.

    Measured: SSB: From Vaccination on Day 1 through 4 Weeks after Vaccination

  24. SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years)

    An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.

    Measured: SSB: From Vaccination on Day 1 through 6 Months after Vaccination

Secondary outcomes (25)

  1. SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)

    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.

    Measured: SSA: Before Vaccination and 4 Weeks after Vaccination

  2. SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)

    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.

    Measured: SSA: Before Vaccination and 4 Weeks after Vaccination

  3. SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)

    GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.

    Measured: SSA: Before Vaccination to 4 Weeks after Vaccination

  4. SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years)

    GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.

    Measured: SSA: Before Vaccination to 4 Weeks after Vaccination

  5. SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)

    Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.

    Measured: SSA: 4 Weeks after Vaccination

  6. SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years)

    Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.

    Measured: SSA: 4 Weeks after Vaccination

  7. SSA: Percentage of Participants With Strain Specific HAI Titers Greater Than or Equal to (>=) 1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)

    Percentage of participants with HAI titer >=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.

    Measured: SSA: Before Vaccination and at 4 Weeks after Vaccination

  8. SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)

    Percentage of participants with HAI titer >=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.

    Measured: SSA: Before Vaccination and at 4 Weeks After Vaccination

  9. SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years)

    Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).

    Measured: SSA: 4 Weeks after Vaccination

  10. SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years)

    Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).

    Measured: SSA: 4 Weeks after Vaccination

  11. SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years)

    Percentage of participants achieving HAI titers >= 1:40 for each strain at 4 weeks after last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).

    Measured: SSA: 4 Weeks after Vaccination

  12. SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years)

    Percentage of participants achieving HAI titers >= 1:40 for each strain at 4 weeks after last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).

    Measured: SSA: 4 Weeks after Vaccination

  13. SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)

    GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination and at 4 week after vaccination were reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

    Measured: SSA: Before Vaccination and 4 Weeks after Vaccination

  14. SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)

    GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination and at 4 week after vaccination was reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

    Measured: SSA: Before Vaccination and 4 Weeks after Vaccination

  15. SSA: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)

    GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

    Measured: SSA: Before Vaccination to 4 Weeks after Vaccination

  16. SSA: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination to 4 Weeks After Vaccination (>=65 Years)

    GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

    Measured: SSA: Before Vaccination to 4 Weeks after Vaccination

  17. SSA: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (18- 64 Years)

    Seroresponse was defined as achieving >= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.

    Measured: SSA: 4 Weeks after Vaccination

  18. SSA: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (>=65 Years)

    Seroresponse was defined as achieving >= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.

    Measured: SSA:4 Weeks after Vaccination

  19. SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)

    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.

    Measured: SSB: Before Vaccination and 4 Weeks after Vaccination

  20. SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)

    GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.

    Measured: SSB: Before Vaccination to 4 Weeks after Vaccination

  21. SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)

    Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria,

    Measured: SSB: 4 Weeks after Vaccination

  22. SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)

    Percentage of participants with HAI titer >=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.

    Measured: SSB: Before Vaccination and at 4 Weeks after Vaccination

  23. SSB: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)

    GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination and at 4 week after vaccination was reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

    Measured: SSB: Before Vaccination and at 4 Weeks after Vaccination

  24. SSB: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)

    GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

    Measured: SSB: 4 Weeks after Vaccination

  25. SSB: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (18- 64 Years)

    Seroresponse was defined as achieving >= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.

    Measured: SSB: 4 Weeks after Vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2022
  2. Study start28 Oct 2022
  3. Primary completion28 Dec 2023
  4. Study completion28 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,019 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05596734
Sponsor's protocol ID
C5261001
Other IDs
NCT05596734
Status last verified
Jul 2025
First submitted
26 Oct 2022
Last updated
23 Jul 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bivalent BNT162b2 (original/Omi BA.4/BA.5), qIRV (22/23) and QIV in people with Influenza, Human and COVID-19, run by BioNTech SE at 59 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years) (time frame: SSA: From Day 1 to Day 7 after Vaccination). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05596734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.

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