A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINES AGAINST INFLUENZA IN HEALTHY ADULTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,202
- 试验地点
- 59
- 主要终点
- SSA - Percentage of Participants Reporting Serious Adverse Events (SAE)
研究概览
简要总结
The purpose of this study is to learn if modified RNA (modRNA) vaccines for the prevention of influenza are:
- safe; and
- how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign.
RNA (also called ribonucleic acid) is one of two types of nucleic acid made by cells. RNA contains information that has been copied from DNA (the other type of nucleic acid). Cells make several different forms of RNA, and each form has a specific job in the cell. Many forms of RNA have functions related to making proteins. RNA is also the genetic material of some viruses instead of DNA. RNA can be made in the laboratory and used in research studies. Also called ribonucleic acid.
Influenza is term used for flu illness. It is an infection caused by a virus that affects your mouth, nose, and throat.
The study is seeking for participants who:
- are at least 18 years of age
- have not received an influenza vaccine within the last 6 months
- are generally healthy
This study will be divided into three sub-studies: Substudy A (SSA), Substudy B (SSB), and Substudy C (SSC).
All participants, regardless of sub-study, will receive 1 dose of either of the following vaccines as an injection into their arm:
- 1 of the modRNA influenza vaccines that is being studied; or
- an approved influenza vaccine approved for use in their respective age group.
Participants will be involved in this study for about 6 months. During this time, participants will have at least 3 clinic visits.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study will be an observer-blinded and Sponsor-unblinded study.
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
- •Applies to all 3 substudies:
- •participants ≥18 years of age.
- •generally healthy participants.
- •Substudy C ONLY:
- •- receipt of licensed influenza vaccination for the 2023-2024 flu season at least 6 months ago.
排除标准
- •All 3 substudies:
- •diagnosis of influenza (by clinical testing) in the last 6 months.
- •immunocompromised individuals with known or suspected immunodeficiency
- •receipt of any investigational or licensed influenza vaccines within 6 months.
研究组 & 干预措施
SSC: QIV3
- Single Dose on Day 1
干预措施: Quadrivalent Influenza Vaccine (QIV) (Biological)
SSC: Influenza ModRNA Vaccine 8C
- Single Dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSC: Influenza ModRNA Vaccine 9C
- Single dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSC: Influenza ModRNA Vaccine 6C
- Single Dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSC: Influenza ModRNA Vaccine 7C
- Single Dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSA: Influenza ModRNA Vaccine 2A
- Single Dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSA: Influenza ModRNA Vaccine 3A
- Single Dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSA: Influenza ModRNA Vaccine 4A
- Single Dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSA: Influenza ModRNA Vaccine 5A
- Single dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSA: QIV1
- Single dose on Day 1
干预措施: Quadrivalent Influenza Vaccine (QIV) (Biological)
SSB: Influenza ModRNA Vaccine 3B
- Single Dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSB: Influenza ModRNA Vaccine 4B
- Single Dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSB: Influenza ModRNA Vaccine 5B
- Single dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSB: QIV2
- Single Dose on Day 1
干预措施: Quadrivalent Influenza Vaccine (QIV) (Biological)
SSB: QIV3
- Single Dose on Day 1
干预措施: Quadrivalent Influenza Vaccine (QIV) (Biological)
SSC: Influenza ModRNA Vaccine 3C
- Single Dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSC: Influenza ModRNA Vaccine 4C
- Single Dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSC: Influenza ModRNA Vaccine 5C
- Single Dose on Day 1
干预措施: Influenza ModRNA Vaccine (Biological)
SSC: QIV2
- Single Dose on Day 1
干预措施: Quadrivalent Influenza Vaccine (QIV) (Biological)
结局指标
主要结局
SSA - Percentage of Participants Reporting Serious Adverse Events (SAE)
时间窗: From Day 1 Through 6 Months After Vaccination
As elicited by investigational site staff
SSA - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
时间窗: From Day 1 Through 6 Months After Vaccination
As elicited by investigational site staff
SSA - Percentage of Participants Reporting Medically Attended AEs (MAEs)
时间窗: From Day 1 Through 6 Months After Vaccination
As elicited by investigational site staff
SSB - Percentage of Participants Reporting Local Reactions After Vaccination
时间窗: From Day 1 Through at least Day 7 After Vaccination
Pain at injection site, redness, and swelling.
SSB - Percentage of Participants Reporting Systemic Events After Vaccination
时间窗: From Day 1 Through at least Day 7 After Vaccination
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
SSB - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
时间窗: From Day 1 Through 6 Months After Vaccination
As elicited by investigational site staff
SSC - Percentage of Participants Reporting Systemic Events After Vaccination
时间窗: From Day 1 Through at least Day 7 After Vaccination
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
SSB - Percentage of Participants Reporting Serious Adverse Events (SAE)
时间窗: From Day 1 Through 6 Months After Vaccination
As elicited by investigational site staff
SSB - Percentage of Participants Reporting Medically Attended AEs (MAEs)
时间窗: From Day 1 Through 6 Months After Vaccination
As elicited by investigational site staff
SSC - Percentage of Participants Reporting Local Reactions After Vaccination
时间窗: From Day 1 Through at least Day 7 After Vaccination
Pain at the injection site, redness, and swelling.
SSC - Percentage of Participants Reporting Adverse Events After Vaccination
时间窗: From Day 1 Through 4 Weeks After Vaccination
As elicited by investigational site staff
SSC - Percentage of Participants Reporting Serious Adverse Events (SAE)
时间窗: From Day 1 Through 6 Months After Vaccination
As elicited by investigational site staff
SSC - Percentage of Participants Reporting Medically Attended AEs (MAEs)
时间窗: From Day 1 Through 6 Months After Vaccination
As elicited by investigational site staff
SSA - Percentage of Participants Reporting Local Reactions After Vaccination
时间窗: From Day 1 Through at least Day 7 After Vaccination
Pain at the injection site, redness, and swelling.
SSA - Percentage of Participants Reporting Systemic Events After Vaccination
时间窗: From Day 1 Through at least Day 7 After Vaccination
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
SSA - Percentage of Participants Reporting Adverse Events After Vaccination
时间窗: From Day 1 Through 4 Weeks After Vaccination
As elicited by investigational site staff
SSC - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
时间窗: From Day 1 Through 6 Months After Vaccination
As elicited by investigational site staff
SSB - Percentage of Participants Reporting Adverse Events After Vaccination
时间窗: From Day 1 Through 4 Weeks After Vaccination
As elicited by investigational site staff
SSA: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
时间窗: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. All local reactions were graded based on center for biologics evaluation and research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
SSB: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
时间窗: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
SSC: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
时间窗: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
SSA: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
时间窗: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
SSB: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
时间窗: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
SSC: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
时间窗: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
时间窗: From study vaccination on Day 1 through 4 weeks after study vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
SSB: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
时间窗: From study vaccination on Day 1 through 4 weeks after study vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
SSC: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
时间窗: From study vaccination on Day 1 through 4 weeks after study vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
SSA: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
时间窗: From study vaccination on Day 1 through 6 months after study 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, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
SSB: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
时间窗: From study vaccination on Day 1 through 6 months after study 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, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
SSC: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
时间窗: From study vaccination on Day 1 through 6 months after study 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, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
SSA: Percentage of Participants With Medically Attended Adverse Events (MAEs) From Vaccination Through 6 Months After Vaccination
时间窗: From study vaccination on Day 1 through 6 months after study vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
SSB: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
时间窗: From study vaccination on Day 1 through 6 months after study vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
SSC: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
时间窗: From study vaccination on Day 1 through 6 months after study vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Through 6 Months After Vaccination
时间窗: From study vaccination on Day 1 through 6 months after study vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
SSB: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
时间窗: From study vaccination on Day 1 through 6 months after study vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
SSC: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
时间窗: From study vaccination on Day 1 through 6 months after study vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
次要结局
- SSA - The proportion of participants with HAI titers ≥1:40 for each strain(Baseline and 4 Weeks After Vaccination)
- SSB - HAI geometric mean titers (GMTs) for each strain(4 Weeks After Vaccination)
- SSA - HAI Geometric Mean Titers (GMTs) for each strain(4 Weeks After Vaccination)
- SSA - HAI geometric mean fold rise (GMFR) for each strain(4 Weeks After Vaccination)
- SSA - The proportion of participants achieving HAI seroconversion for each strain(4 Weeks After Vaccination)
- SSB - The proportion of participants achieving HAI seroconversion for each strain(4 Weeks After Vaccination)
- SSB - The proportion of participants with HAI titers ≥1:40 for each strain(Baseline and 4 Weeks After Vaccination)
- SSB - HAI geometric mean fold rise (GMFR) for each strain(4 Weeks After Vaccination)
- SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination(Baseline (before study vaccination on Day 1), 4 weeks after study vaccination)
- SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination(From before study vaccination on Day 1 up to 4 weeks after study vaccination)
- SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination(4 weeks after study vaccination)
- SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination(Baseline (before study vaccination on Day 1), 4 weeks after study vaccination)
- SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination(Baseline (before study vaccination on Day 1), 4 weeks after study vaccination)
- SSB: GMFRs of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination(From before study vaccination on Day 1 up to 4 weeks after study vaccination)
- SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination(4 weeks after study vaccination)
- SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination(Baseline (before study vaccination on Day 1), 4 weeks after study vaccination)