Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
2015년 10월 29일 업데이트: Novartis
A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
연구 개요
연구 유형
중재적
등록 (실제)
2719
단계
- 2 단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Tlalpan, 멕시코, 14000
- Instituto Nacional de Ciencias
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Florida
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Miami, Florida, 미국, 33143
- Miami Research Associates
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Kansas
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Lenexa, Kansas, 미국, 66219
- Johnson County Clin-Trials
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Nebraska
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Omaha, Nebraska, 미국, 68134
- Meridien Clinical Research
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New York
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Endwell, New York, 미국, 13760
- Regional Clinical Research
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Rochester, New York, 미국, 14609
- Rochester Clinical Research, Inc
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North Carolina
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Cary, North Carolina, 미국, 27518
- Triangle Medical Research Associates
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Raleigh, North Carolina, 미국, 27609
- Triangle Medical Research Associates
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Winston-Salem, North Carolina, 미국, 27103
- Carolina Medical Trials
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Ohio
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Franklin, Ohio, 미국, 45005
- Prestige Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73103
- IPS Research
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Pennsylvania
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Erie, Pennsylvania, 미국, 16506
- West Ridge Family Practice (adult)
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Jefferson Hills, Pennsylvania, 미국, 15025
- Primary Physicians Research Inc. (adult)
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Rhode Island
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Warwick, Rhode Island, 미국, 02886
- Omega Clinical Research
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Texas
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Dallas, Texas, 미국, 75234
- Research Across America
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Houston, Texas, 미국, 77055
- West Houston Clinical Research Service
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Utah
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Salt Lake City, Utah, 미국, 84121
- J. Lewis Research, Inc./Foothill Family Clinic South
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Salt Lake City, Utah, 미국, 84109
- J.Lewis Research, Inc./Foothill Family Clinic
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Virginia
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Burke, Virginia, 미국, 22015
- Pi-Coor Clinical Research
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Fairfax, Virginia, 미국, 22030
- PI Coor Clinical Research
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Richmond, Virginia, 미국, 23219
- Virginia Commonwealth University
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion Criteria:
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
- Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
- For additional entry criteria, please refer to protocol.
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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 3.75_(50)MF59
50% of MF59 with 3.75 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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실험적: 7.5 w/o MF59
0% of MF59 with 7.5 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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실험적: 7.5_(50)MF59
50% of MF59 with 7.5 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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실험적: 7.5_(100)MF59
100% of MF59 with 7.5 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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실험적: 15 w/o MF59
0% of MF59 with 15 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
|
|
실험적: 15_(50)MF59
50% of MF59 with 15 µg A/H1N1 antigen
|
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
|
|
실험적: 15_(100)MF59
100% of MF59 with 15 µg A/H1N1 antigen
|
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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실험적: 30 w/o MF59
0% of MF59 with 30 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
기간: 21 days after each vaccination
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Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Seroprotection is defined as participants having HI antibody titer ≥1:40.
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21 days after each vaccination
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Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
기간: 21 days after each vaccination
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Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Seroprotection is defined as participants having HI antibody titer ≥1:40.
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21 days after each vaccination
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
기간: 21 days after each vaccination
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Geometric mean hemagglutinin inhibition (HI) titer = GMT
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21 days after each vaccination
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Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
기간: 21 days after each vaccination
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Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria.
Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
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21 days after each vaccination
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Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
기간: 21 days after each vaccination
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Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria.
Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
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21 days after each vaccination
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Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
기간: 21 days after vaccination
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Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria.
Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.
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21 days after vaccination
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Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
기간: 7 days after vaccination
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Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
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7 days after vaccination
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Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
기간: 7 days after vaccination
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Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
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7 days after vaccination
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Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
기간: 7 days after vaccination
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Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
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7 days after vaccination
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Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
기간: 7 days after vaccination
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Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
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7 days after vaccination
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 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
2009년 9월 1일
기본 완료 (실제)
2009년 11월 1일
연구 완료 (실제)
2010년 12월 1일
연구 등록 날짜
최초 제출
2009년 9월 2일
QC 기준을 충족하는 최초 제출
2009년 9월 7일
처음 게시됨 (추정)
2009년 9월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 12월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 10월 29일
마지막으로 확인됨
2015년 10월 1일
추가 정보
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. .