성인을 대상으로 한 새로운 폐렴구균 백신의 안전성과 면역반응에 관한 연구
18세 이상 성인을 대상으로 한 다가 폐렴구균 접합 백신의 안전성과 면역원성에 대한 1/2상, 무작위, 이중 맹검 시험
The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease.
This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulations) or 20vPnC (Prevnar 20) as a single shot given into the upper arm muscle.
Stage 2 will begin after participants have completed Stage 1, and a pneumococcal vaccine candidate has been decided.
Stage 2 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20). The vaccines will be given as a single shot into the upper arm muscle.
Stage 3 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or a licensed pneumococcal comparator vaccine. The vaccines will be given as a single shot into the upper arm muscle.
Stage 4 is seeking participants who are adults 50 years of age and older. The participants will receive either one of three pneumococcal vaccine candidates or one of two licensed pneumococcal comparator vaccines. The vaccines will be given as a single shot into the upper arm muscle.
Participants will take part in this study for about 6 months for Stage 1, Stage 3, and Stage 4 and 12 months for Stage 2. During this time participants will have from 2 to 4 clinic visits and 1 phone visit. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these clinic visits.
연구 개요
상태
정황
개입 / 치료
- 생물학적: Multivalent Pneumococcal Vaccine - Formulation 3
- 생물학적: Multivalent Pneumococcal Vaccine - Formulation 1
- 생물학적: 20-valent pneumococcal conjugate vaccine (20vPnC)
- 생물학적: Multivalent Pneumococcal Vaccine - Formulation 2
- 생물학적: Licensed pneumococcal comparator vaccine
- 생물학적: Multivalent Pneumococcal Vaccine - Formulation 4
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Florida
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Doral, Florida, 미국, 33172
- Alliance for Multispecialty Research, LLC
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Hialeah, Florida, 미국, 33012
- Indago Research & Health Center, Inc
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Georgia
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Stockbridge, Georgia, 미국, 30281
- Clinical Research Atlanta
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Illinois
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Peoria, Illinois, 미국, 61614
- Optimal Research
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Louisiana
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New Orleans, Louisiana, 미국, 70119
- Alliance for Multispecialty Research, LLC
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Michigan
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Southfield, Michigan, 미국, 48034
- Headlands Research - Detroit
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New York
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Rochester, New York, 미국, 14609
- Rochester Clinical Research, LLC
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Tarrytown, New York, 미국, 10591
- IMA Evaluations, LLC dba IMA Clinical Research
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North Carolina
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Wilmington, North Carolina, 미국, 28401
- Accellacare - Wilmington
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Tennessee
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Knoxville, Tennessee, 미국, 37909
- AMR Clinical
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Knoxville, Tennessee, 미국, 37920
- AMR Clinical
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Texas
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Brownsville, Texas, 미국, 78526
- Headlands Horizons LLC
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Houston, Texas, 미국, 77065
- DM Clinical Research- Cyfair
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San Antonio, Texas, 미국, 78229
- IMA Clinical Research San Antonio
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San Antonio, Texas, 미국, 78229
- Clinical Trials of Texas, LLC dba Flourish Research
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Sugarland, Texas, 미국, 77478
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Tomball, Texas, 미국, 77375
- DM Clinical 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, 84109
- J. Lewis Research, Inc.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female participants ≥18 to<50 years of age (Stage 1) and ≥50 years of age (Stage 2, Stage 3, and Stage 4) at the time of consent
- Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
- Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children
- Phase 1 (Stage 1): Adults 18 through 49 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve)
- Phase 2 (Stages 2, 3, and 4): Adults ≥50 through 64 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve) and adults 65 years of age and older with either no history of ever receiving a pneumococcal vaccine or who received PPSV23 >5 years prior to the first vaccination in this study (ie, experienced)
Exclusion Criteria:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
- Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
- Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
- Known or suspected immunodeficiency or other conditions associated with immunosuppression
- Planned receipt of any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
- Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3. |
Multivalent pneumococcal conjugate vaccine |
|
실험적: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
|
활성 비교기: Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC)
Participants to receive a single injection of 20vPnC. |
20-valent pneumococcal conjugate vaccine (20vPnC)
다른 이름들:
|
|
실험적: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
|
활성 비교기: Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine
Participants to receive a single injection of a licensed pneumococcal comparator vaccine. |
A licensed pneumococcal comparator vaccine |
|
실험적: Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4. |
Multivalent pneumococcal conjugate vaccine |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of participants reporting prespecified local reactions within 7 days after vaccination
기간: 7 days
|
Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination |
7 days
|
|
Percentage of participants reporting prespecified systemic events within 7 days after vaccination
기간: 7 days
|
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination |
7 days
|
|
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
기간: 1 month
|
Adverse events occurring within 1 month after vaccination |
1 month
|
|
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
기간: 6 months
|
SAEs occurring within 6 months after vaccination |
6 months
|
|
Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination
기간: 12 months
|
Related SAEs occurring through 12 months after vaccination |
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
기간: 1 month after vaccination
|
Pneumococcal OPA GMTs 1 month after vaccination |
1 month after vaccination
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- C4931001
- NCT06182124 (레지스트리 식별자: ClinicalTrials.gov)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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