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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- BioNTech SE
- 入组人数
- 1,019
- 试验地点
- 54
- 主要终点
- SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Participant)
盲法说明
Substudy A: Open-label unblinded.
Substudy B: Participants are blinded to their assigned study intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5)
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: tIRV (Biological)
SSA: qIRV + bivalent BNT162b2 (dose level combination 1)
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSA: qIRV + bivalent BNT162b2 (dose level combination 1)
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSA: qIRV + bivalent BNT162b2 (dose level combination 2)
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSA: qIRV + bivalent BNT162b2 (dose level combination 2)
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSA: qIRV + bivalent BNT162b2 (dose level combination 3)
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSA: qIRV + bivalent BNT162b2 (dose level combination 3)
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSA: qIRV (dose level 1)
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSA: qIRV (dose level 2)
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 1
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 5
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSA: bivalent BNT162b2 (dose level 1) + QIV
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSA: bivalent BNT162b2 (dose level 1) + QIV
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
干预措施: QIV (Biological)
SSB: QIV + bivalent BNT162b2 (original/Omi BA.4/BA.5)
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSB: QIV + bivalent BNT162b2 (original/Omi BA.4/BA.5)
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
干预措施: QIV (Biological)
SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5)
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5)
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
干预措施: QIV (Biological)
SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5)
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
干预措施: bIRV (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 1
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 2
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 2
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 3
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 3
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 4
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 4
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 5
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 6
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 6
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 7
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 7
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 8
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 8
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5)
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)
SSB: qIRV
Administered intramuscularly into the deltoid muscle of the right arm
干预措施: qIRV (22/23) (Biological)
结局指标
主要结局
SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years)
时间窗: SSA: From Day 1 to Day 7 after Vaccination
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: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years)
时间窗: SSA: From Day 1 to Day 7 after Vaccination
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: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years)
时间窗: SSA: From Day 1 to Day 7 after Vaccination
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: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years)
时间窗: SSA: From Day 1 to Day 7 after Vaccination
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: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years)
时间窗: SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination
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: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years)
时间窗: SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination
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: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years)
时间窗: SSA: From Vaccination on Day 1 through 6 Months after Vaccination
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: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years)
时间窗: SSA: From Vaccination on Day 1 through 6 Months after Vaccination
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: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years)
时间窗: SSA: 2 Days after Vaccination
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years)
时间窗: SSA: 2 Days after Vaccination
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years)
时间窗: SSA: 1 Week After Vaccination
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years)
时间窗: SSA: 1 Week After Vaccination
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years)
时间窗: SSA: 2 Days after Vaccination
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: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years)
时间窗: SSA: 2 Days after Vaccination
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: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years)
时间窗: SSA: 1 Week after Vaccination
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: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years)
时间窗: SSA: 1 Week after Vaccination
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: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years)
时间窗: SSB: 2 Days after Vaccination
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years)
时间窗: SSB: 1 Week after Vaccination
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years)
时间窗: SSB: 2 Days after Vaccination
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: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years)
时间窗: SSB: 1 Week after Vaccination
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: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years)
时间窗: SSB: From Day 1 to Day 7 after Vaccination
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: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years)
时间窗: SSB: From Day 1 to Day 7 after Vaccination
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: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years)
时间窗: SSB: From Vaccination on Day 1 through 4 Weeks after Vaccination
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: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years)
时间窗: SSB: From Vaccination on Day 1 through 6 Months after Vaccination
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.
次要结局
- 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)
- SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years)(SSA: 4 Weeks after Vaccination)
- 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)(SSA: Before Vaccination and at 4 Weeks after Vaccination)
- SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)(SSA: Before Vaccination and at 4 Weeks After Vaccination)
- SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years)(SSA: 4 Weeks after Vaccination)
- SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years)(SSA: 4 Weeks after Vaccination)
- SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years)(SSA: 4 Weeks after Vaccination)
- SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years)(SSA: 4 Weeks after Vaccination)
- 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)(SSA: Before Vaccination and 4 Weeks after Vaccination)
- 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)(SSA: Before Vaccination and 4 Weeks after Vaccination)
- 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)(SSA: Before Vaccination to 4 Weeks after Vaccination)
- 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)(SSA: Before Vaccination to 4 Weeks after Vaccination)
- 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)(SSA: 4 Weeks after Vaccination)
- 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)(SSA:4 Weeks after Vaccination)
- SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)(SSB: Before Vaccination and 4 Weeks after Vaccination)
- SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)(SSB: Before Vaccination to 4 Weeks after Vaccination)
- SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)(SSB: 4 Weeks after Vaccination)
- SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)(SSB: Before Vaccination and at 4 Weeks after Vaccination)
- 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)(SSB: Before Vaccination and at 4 Weeks after Vaccination)
- 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)(SSB: 4 Weeks after Vaccination)
- 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)(SSB: 4 Weeks after Vaccination)