건강한 성인의 인플루엔자에 대한 변형된 RNA 백신에 관한 연구
2026년 6월 9일 업데이트: Pfizer
건강한 성인을 대상으로 인플루엔자에 대한 변형 RNA 백신의 안전성, 내약성 및 면역원성을 평가하기 위한 연구
이 연구의 목적은 인플루엔자 예방을 위한 변형 RNA(modRNA) 백신이 다음과 같은지 알아보는 것입니다.
- 안전한; 그리고
- 이 백신이 일반적으로 건강한 성인에게 어떻게 면역 반응을 일으키는지. 면역 반응은 신체가 해롭거나 이물질로 간주되는 것으로부터 자신을 보호하는 방식입니다.
RNA(리보핵산이라고도 함)는 세포에서 생성되는 두 가지 유형의 핵산 중 하나입니다. RNA에는 DNA(다른 유형의 핵산)에서 복사된 정보가 포함되어 있습니다. 세포는 여러 가지 다른 형태의 RNA를 만들고, 각 형태는 세포에서 특정한 역할을 합니다. 많은 형태의 RNA는 단백질 생성과 관련된 기능을 가지고 있습니다. RNA는 DNA 대신 일부 바이러스의 유전 물질이기도 합니다. RNA는 실험실에서 만들어지고 연구에 사용될 수 있습니다. 리보핵산이라고도 합니다.
인플루엔자는 독감 질환에 사용되는 용어입니다. 입, 코, 목에 영향을 미치는 바이러스에 의한 감염입니다.
이 연구에서는 다음과 같은 참가자를 찾고 있습니다.
- 18세 이상입니다
- 지난 6개월 이내에 인플루엔자 백신을 접종받지 않은 경우
- 일반적으로 건강하다
본 연구는 하위 연구 A(SSA), 하위 연구 B(SSB), 하위 연구 C(SSC)의 세 가지 하위 연구로 나누어집니다.
하위 연구에 관계없이 모든 참가자는 팔에 주사로 다음 백신 중 하나를 1회 투여받게 됩니다.
- 연구 중인 modRNA 인플루엔자 백신 중 1개; 또는
- 해당 연령 그룹에서 사용하도록 승인된 승인된 인플루엔자 백신.
참가자들은 약 6개월 동안 본 연구에 참여하게 됩니다. 이 기간 동안 참가자는 최소 3번의 진료소 방문을 하게 됩니다.
연구 개요
연구 유형
중재적
등록 (실제)
1202
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Mobile, Alabama, 미국, 36608
- AMR Clinical
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Arizona
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Scottsdale, Arizona, 미국, 85260
- Headlands Research - Scottsdale
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California
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Anaheim, California, 미국, 92801
- Anaheim Clinical Trials, LLC
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Lake Forest, California, 미국, 92630
- Orange County Research Center
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San Diego, California, 미국, 92103
- Artemis Institute for Clinical Research
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Walnut Creek, California, 미국, 94598
- Diablo Clinical Research, Inc.
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Connecticut
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Milford, Connecticut, 미국, 06460
- Clinical Research Consulting
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Florida
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Hialeah, Florida, 미국, 33012
- Indago Research & Health Center, Inc
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Hollywood, Florida, 미국, 33024
- Research Centers of America
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Hollywood, Florida, 미국, 33024
- Research Centers of America ( Hollywood )
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Miami Lakes, Florida, 미국, 33014
- Palm Springs Community Health Center
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Orlando, Florida, 미국, 32801
- Clinical Neuroscience Solutions, Inc.
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Orlando, Florida, 미국, 32819
- Headlands Research Orlando
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South Miami, Florida, 미국, 33143
- Qps-Mra, Llc
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Hawaii
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Honolulu, Hawaii, 미국, 96814
- East-West Medical Research Institute
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Louisiana
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New Orleans, Louisiana, 미국, 70119
- Alliance for Multispecialty Research, LLC
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Minnesota
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Saint Paul, Minnesota, 미국, 55114
- Prism Research LLC dba Nucleus Network
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Missouri
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Chesterfield, Missouri, 미국, 63005
- Clinical Research Professionals
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Kansas City, Missouri, 미국, 64114
- Alliance for Multispecialty Research, LLC
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New York
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Rochester, New York, 미국, 14609
- Rochester Clinical Research, LLC
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North Carolina
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Durham, North Carolina, 미국, 27703
- Duke Vaccine and Trials Unit
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Raleigh, North Carolina, 미국, 27612
- M3 Wake Research, Inc.
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- DM Clinical Research - Philadelphia
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Texas
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Brownsville, Texas, 미국, 78526
- Headlands Horizons LLC
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Mesquite, Texas, 미국, 75149
- SMS Clinical Research
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San Antonio, Texas, 미국, 78229
- Clinical Trials of Texas, LLC
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San Antonio, Texas, 미국, 78229
- Clinical Trials of Texas, LLC dba Flourish Research
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Tomball, Texas, 미국, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Utah
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Salt Lake City, Utah, 미국, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, 미국, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Virginia
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Charlottesville, Virginia, 미국, 22911
- Charlottesville Medical Research
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Norfolk, Virginia, 미국, 23502
- AMR Clinical
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
주요 포함 기준
3개 하위 연구 모두에 적용됩니다.
- 참가자는 18세 이상입니다.
- 일반적으로 건강한 참가자.
하위 연구 C만 해당:
- 최소 6개월 전에 2023~2024년 독감 시즌에 허가된 인플루엔자 예방접종을 받은 경우.
주요 제외 기준
3개 하위 연구 모두:
- 지난 6개월 동안 인플루엔자 진단(임상 테스트를 통해).
- 면역 결핍이 알려졌거나 의심되는 면역 저하자
- 6개월 이내에 연구용 또는 허가된 인플루엔자 백신을 접종한 경우.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: SSA: 인플루엔자 ModRNA 백신 2A
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSA: 인플루엔자 ModRNA 백신 3A
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSA: 인플루엔자 ModRNA 백신 4A
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSA: 인플루엔자 ModRNA 백신 5A
- 첫날 1회 투여
|
근육 주사
|
|
활성 비교기: SSA: QIV1
- 첫날 1회 투여
|
근육 주사
|
|
실험적: SSB: 인플루엔자 ModRNA 백신 3B
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSB: 인플루엔자 ModRNA 백신 4B
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSB: 인플루엔자 ModRNA 백신 5B
- 첫날 1회 투여
|
근육 주사
|
|
활성 비교기: SSB: QIV2
- 1일차에 단일 투여
|
근육 주사
|
|
활성 비교기: SSB: QIV3
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSC: 인플루엔자 ModRNA 백신 3C
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSC: 인플루엔자 ModRNA 백신 4C
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSC: 인플루엔자 ModRNA 백신 5C
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSC: 인플루엔자 ModRNA 백신 6C
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSC: 인플루엔자 ModRNA 백신 7C
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSC: 인플루엔자 ModRNA 백신 8C
- 1일차에 단일 투여
|
근육 주사
|
|
실험적: SSC: 인플루엔자 ModRNA 백신 9C
- 첫날 1회 투여
|
근육 주사
|
|
활성 비교기: SSC: QIV2
- 1일차에 단일 투여
|
근육 주사
|
|
활성 비교기: SSC: QIV3
- 1일차에 단일 투여
|
근육 주사
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
SSA: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
기간: 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.
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From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
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SSB: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
기간: 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.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
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SSC: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
기간: 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.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSA: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
기간: 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.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
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SSB: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
기간: 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.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSC: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
기간: 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.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
기간: 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.
|
From study vaccination on Day 1 through 4 weeks after study vaccination
|
|
SSB: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
기간: 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.
|
From study vaccination on Day 1 through 4 weeks after study vaccination
|
|
SSC: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
기간: 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.
|
From study vaccination on Day 1 through 4 weeks after study vaccination
|
|
SSA: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
기간: 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.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSB: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
기간: 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.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSC: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
기간: 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.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSA: Percentage of Participants With Medically Attended Adverse Events (MAEs) From Vaccination Through 6 Months After Vaccination
기간: 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.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSB: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
기간: 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.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSC: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
기간: 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.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Through 6 Months After Vaccination
기간: 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).
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSB: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
기간: 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).
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSC: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
기간: 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).
|
From study vaccination on Day 1 through 6 months after study vaccination
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
기간: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
|
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
기간: From before study vaccination on Day 1 up to 4 weeks after study vaccination
|
GMFR was defined as the geometric mean of the fold rise in the assay results from before vaccination to a specified time point 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
기간: 4 weeks after study vaccination
|
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 at least a 4-fold rise at the time point of interest.
|
4 weeks after study vaccination
|
|
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
기간: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
|
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
기간: Baseline (before study vaccination on Day 1), 4 weeks after study 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
기간: From before study vaccination on Day 1 up to 4 weeks after study 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
기간: 4 weeks after study vaccination
|
4 weeks after study vaccination
|
|
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SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
기간: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
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Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 5월 23일
기본 완료 (실제)
2025년 2월 5일
연구 완료 (실제)
2025년 2월 5일
연구 등록 날짜
최초 제출
2024년 5월 24일
QC 기준을 충족하는 최초 제출
2024년 5월 30일
처음 게시됨 (실제)
2024년 5월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 9일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- C4781013
- NCT06436703 (레지스트리 식별자: ClinicalTrials.gov)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
화이자는 식별되지 않은 개별 참가자 데이터 및 관련 연구 문서(예:
프로토콜, 통계 분석 계획(SAP), 임상 연구 보고서(CSR))는 자격을 갖춘 연구자의 요청에 따라 제공되며 특정 기준, 조건 및 예외가 적용됩니다.
화이자의 데이터 공유 기준 및 액세스 요청 프로세스에 대한 자세한 내용은 https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests에서 확인할 수 있습니다.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .