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

NCT05596734 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: C5261001NCT05596734
• Study Type: interventional
• Target: 1,019
• Locations: 1 country
• Sites: 59

Brief 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). 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).

Conditions

Influenza, Human; COVID-19

Keywords

SARS-Cov-2; COVID-19; Influenza; Grippe; Flu; Vaccine; RNA vaccine

Outcome Measures

Primary Outcomes (24)

• 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.

  SSA: From Day 1 to Day 7 after Vaccination

• 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.

  SSA: From Day 1 to Day 7 after Vaccination

• 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.

  SSA: From Day 1 to Day 7 after Vaccination

• 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.

  SSA: From Day 1 to Day 7 after Vaccination

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

  SSA: 2 Days after Vaccination

• 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.

  SSA: 2 Days after Vaccination

• 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.

  SSA: 1 Week After Vaccination

• 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.

  SSA: 1 Week After Vaccination

• 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.

  SSA: 2 Days after Vaccination

• 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.

  SSA: 2 Days after Vaccination

• 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.

  SSA: 1 Week after Vaccination

• 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.

  SSA: 1 Week after Vaccination

• 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.

  SSB: 2 Days after Vaccination

• 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.

  SSB: 1 Week after Vaccination

• 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.

  SSB: 2 Days after Vaccination

• 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.

  SSB: 1 Week after Vaccination

• 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.

  SSB: From Day 1 to Day 7 after Vaccination

• 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.

  SSB: From Day 1 to Day 7 after Vaccination

• 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.

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

• 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.

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

Secondary Outcomes (25)

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

  SSA: Before Vaccination and 4 Weeks after Vaccination

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

  SSA: Before Vaccination and 4 Weeks after Vaccination

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

  SSA: Before Vaccination to 4 Weeks after Vaccination

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

  SSA: Before Vaccination to 4 Weeks after Vaccination

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

  SSA: 4 Weeks after Vaccination

Study Arms (18)

SSA: qIRV + bivalent BNT162b2 (dose level combination 1)

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)

SSA: qIRV + bivalent BNT162b2 (dose level combination 2)

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)

SSA: qIRV + bivalent BNT162b2 (dose level combination 3)

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)

SSA: qIRV (dose level 1)

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

Biological: qIRV (22/23)

SSA: qIRV (dose level 2)

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

Biological: qIRV (22/23)

SSA: bivalent BNT162b2 (dose level 1) + QIV

EXPERIMENTAL

BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm

Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: QIV

SSB: QIV + bivalent BNT162b2 (original/Omi BA.4/BA.5)

EXPERIMENTAL

BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm

Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: QIV

SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5)

EXPERIMENTAL

BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm

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 1

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

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 2

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

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 3

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

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 4

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

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 5

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

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 6

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

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 7

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

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 8

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23)

SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5)

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: tIRV

SSB: qIRV

EXPERIMENTAL

Administered intramuscularly into the deltoid muscle of the right arm

Biological: qIRV (22/23)

Interventions

bivalent BNT162b2 (original/Omi BA.4/BA.5) BIOLOGICAL

Intramuscular injection

SSA: bivalent BNT162b2 (dose level 1) + QIV; SSA: qIRV + bivalent BNT162b2 (dose level combination 1); SSA: qIRV + bivalent BNT162b2 (dose level combination 2); SSA: qIRV + bivalent BNT162b2 (dose level combination 3); SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5); SSB: QIV + bivalent BNT162b2 (original/Omi BA.4/BA.5); SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 1; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 2; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 3; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 4; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 5; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 6; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 7; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 8; SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5)

qIRV (22/23) BIOLOGICAL

Intramuscular injection

SSA: qIRV (dose level 1); SSA: qIRV (dose level 2); SSA: qIRV + bivalent BNT162b2 (dose level combination 1); SSA: qIRV + bivalent BNT162b2 (dose level combination 2); SSA: qIRV + bivalent BNT162b2 (dose level combination 3); SSB: qIRV; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 1; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 2; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 3; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 4; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 5; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 6; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 7; SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 8

QIV BIOLOGICAL

Intramuscular injection

SSA: bivalent BNT162b2 (dose level 1) + QIV; SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5); SSB: QIV + bivalent BNT162b2 (original/Omi BA.4/BA.5)

bIRV BIOLOGICAL

Intramuscular injection

SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5)

tIRV BIOLOGICAL

Intramuscular injection

SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioNTech SE: lead
• Pfizer: collaborator

Study Sites (59)

North Alabama Research Center

Athens, Alabama, 35611, United States

Location

The Heart Center

Athens, Alabama, 35611, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85018, United States

Location

The Pain Center of Arizona

Phoenix, Arizona, 85018, United States

Location

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Orange County Heart Institute

Orange, California, 92868, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, 33308, United States

Location

Finlay Medical Research

Greenacres City, Florida, 33467, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

Research Centers of America ( Hollywood )

Hollywood, Florida, 33024, United States

Location

Angels Clinical Research Institute

Miami, Florida, 33122, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Gerardo Polanco, MD

Miami, Florida, 33156, United States

Location

Research Institute of South Florida

Miami, Florida, 33173, United States

Location

Entrust Clinical Research

Miami, Florida, 33176, United States

Location

Jackson Medical Group Cardiac Care

Miami, Florida, 33176, United States

Location

Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States

Location

Palm Springs Community Health Center

Miami Lakes, Florida, 33014, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Palm Springs Community Health Center

Miami Lakes, Florida, 33016, United States

Location

Innovation Medical Research Center

Palmetto Bay, Florida, 33157, United States

Location

DBC Research USA

Pembroke Pines, Florida, 33029, United States

Location

United Medical Research

Port Orange, Florida, 32127, United States

Location

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States

Location

Savannah Medical Group

Savannah, Georgia, 31419, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, 60640, United States

Location

Retina Associates

Elmhurst, Illinois, 60126, United States

Location

Affinity Health

Oak Brook, Illinois, 60523, United States

Location

Alliance for Multispecialty Research, LLC

Oak Brook, Illinois, 60523, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67207, United States

Location

Jadestone Clinical Research

Silver Spring, Maryland, 20904, United States

Location

Michigan Center of Medical Research (MICHMER)

Farmington Hills, Michigan, 48334, United States

Location

Pradeep Chandra, DO, FACC

Bridgeton, Missouri, 63044, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Pioneer Heart Institute

Lincoln, Nebraska, 68506, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

Location

ActivMed Practices & Research, LLC.

Portsmouth, New Hampshire, 03801, United States

Location

SUNY Upstate Medical University Institute for Global Health

Syracuse, New York, 13215, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States

Location

Main Street Physician's Care

Little River, South Carolina, 29566, United States

Location

McLeod Cardiology Associates - Little River

Little River, South Carolina, 29566, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37909, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Prolato Clinical Research Center

Houston, Texas, 77054, United States

Location

DM Clinical Research, Martin Diagnostic Clinic

Tomball, Texas, 77375, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Related Links

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

MeSH Terms

Conditions

Influenza, Human; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases

Results Point of Contact

• Title: BioNTech clinical trials patient information
• Organization: BioNTech SE

patients@biontech.de

+49 6131 90840

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Substudy A: Open-label unblinded. Substudy B: Participants are blinded to their assigned study intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 27, 2022
• Study Start: October 28, 2022
• Primary Completion: December 28, 2023
• Study Completion: December 28, 2023
• Last Updated: July 23, 2025
• Results First Posted: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (59)