플루존® HD 백신의 면역원성에 대한 CD388 효과 평가 시험
플루존® 고용량 인플루엔자 백신과 신규 장기 지속형 항바이러스 접합체인 CD388을 동시 투여했을 때의 안전성과 면역원성을 평가하기 위한 1상, 이중 맹검, 무작위 임상시험
Approximately one billion cases of seasonal influenza occur annually. Of these, 3 to 5 million illnesses are severe and responsible for up to 650,000 deaths per year (WHO 2025). Yearly administration of an influenza vaccine for the prevention of influenza is currently recommended. However, the real-world vaccine effectiveness varied from 10% to 60% in the general population across the years of 2004 to 2024, with effectiveness in most years below 50% (CDC 2025) and decreasing to as low as 5% in immunocompromised individuals (Hughes 2021). Researchers are looking for other ways to prevent severe illness from the influenza virus.
The goals of this study are to learn if:
- MK-1406 (formerly CD388) is safe to take with Fluzone®
- MK-1406 affects the immune response to Fluzone®
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This is a Phase 1, double-blind, randomized trial to evaluate the immunogenicity of Fluzone® HD influenza vaccine when concomitantly administered with either MK-1406 or placebo, in healthy participants. This study will also evaluate the safety and tolerability of MK-1406 when administered with Fluzone® High-Dose (HD) compared to Fluzone® HD with placebo.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Toll Free Number
- 전화번호: 1-888-577-8839
- 이메일: Trialsites@msd.com
연구 장소
-
-
California
-
Glendale, California, 미국, 91206
- 모병
- Parexel ( Site 0001)
-
연락하다:
- Study Coordinator
- 전화번호: 888-228-7425
-
-
Maryland
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Baltimore, Maryland, 미국, 21225
- 모병
- Parexel ( Site 0002)
-
연락하다:
- Study Coordinator
- 전화번호: 410-350-3200
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Be ≥18 to ≤49 years of age
- Be deemed healthy by the Investigator
- Have not received any seasonal influenza vaccine and have not had a diagnosed or suspected influenza infection within 12 months prior to Day 1 of the trial
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Had an active malignancy within 5 years prior to screening, except basal cell or squamous cell skin cancer. Any history of breast cancer or melanoma is exclusionary.
- Has previously been diagnosed with Guillain-Barre Syndrome following a previous influenza vaccination.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Fluzone® High-Dose (HD) plus MK-1406
Participants will receive open-label Fluzone® HD influenza vaccine by intramuscular (IM) injection plus MK-1406 by subcutaneous (SC) injection on Day 1. |
Fluzone® HD injectable suspension administered by intramuscular (IM) injection
다른 이름들:
MK-1406 liquid for injection administered subcutaneously
다른 이름들:
|
|
위약 비교기: Fluzone® HD plus Placebo
Participants will receive open-label Fluzone® HD influenza vaccine by IM injection plus placebo by SC injection on Day 1. |
Fluzone® HD injectable suspension administered by intramuscular (IM) injection
다른 이름들:
MK-1406 matched liquid for SC injection |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Geometric Mean of Hemagglutinin Inhibition (HAI) Titers Against the Influenza Strains Contained in the Vaccine Among Participants Receiving Concomitant Fluzone® High-Dose (HD) and MK-1406 Compared to Participants Who Receive Fluzone® HD and Placebo
기간: Predose (Day 1), Day 15 and Day 29
|
Geometric mean of HAI titers at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. HAI testing will be performed using validated methods in accordance with applicable Good Clinical Laboratory Practice (GCLP) and laboratory Standard Operating Procedures (SOPs). Geometric Mean Titers (GMTs) will be summarized by treatment group and influenza strain. |
Predose (Day 1), Day 15 and Day 29
|
|
Percentage of Participants with Seroconversion Rates against the Influenza Strains Contained in the Vaccine Among Participants Receiving Concomitant Fluzone® HD and MK-1406 Compared to Participants Who Receive Fluzone® HD and Placebo
기간: Predose (Day 1), Day 15 and Day 29
|
Seroconversion is defined as a 4-fold increase in influenza titer as measured by HAI assay at each visit compared to baseline. Seroconversion rates at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. Seroconversion rates will be summarized by treatment group and influenza strain. |
Predose (Day 1), Day 15 and Day 29
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of participants with ≥1 Adverse Event (AE)
기간: Up to approximately Day 29
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
Up to approximately Day 29
|
|
Percentage of Participants Who Discontinued from the Study Due to an Adverse Event
기간: Up to approximately Day 29
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinued the study because of an AE (as defined above) will be assessed. |
Up to approximately Day 29
|
|
Percentage of Participants with a Solicited Injection-site Adverse Event
기간: Up to approximately Day 8 post-dose
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs assessed are redness/erythema, swelling, and tenderness/pain. |
Up to approximately Day 8 post-dose
|
|
Percentage of Participants with a Solicited Systemic Adverse Event
기간: Up to approximately Day 29
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The solicited systemic AEs assessed are muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. |
Up to approximately Day 29
|
공동 작업자 및 조사자
스폰서
스폰서
수사관
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 1406-007
- CD388.SQ.1.08 (기타 식별자: Cidara)
- MK-1406-007 (기타 식별자: MSD)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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