A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
2011년 8월 26일 업데이트: Sanofi
Immunogenicity and Safety of Multiple Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly.
Primary Objectives:
- To describe the immunogenicity of the candidate vaccines after a single injection.
- To describe the safety of the candidate vaccines after a single injection.
연구 개요
상태
완전한
상세 설명
Participants will receive a single injection of their randomized vaccine on Day 0.
연구 유형
중재적
등록 (실제)
548
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Anaheim, California, 미국, 92801
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Fountain Valley, California, 미국, 92708
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Florida
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South Miami, Florida, 미국, 33143
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Missouri
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Springfield, Missouri, 미국, 65802
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New York
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Rochester, New York, 미국, 14609
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North Carolina
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Raleigh, North Carolina, 미국, 27612
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Ohio
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Cincinnati, Ohio, 미국, 45227
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Cleveland, Ohio, 미국, 44122
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Pennsylvania
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Grove City, Pennsylvania, 미국, 16127
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Jefferson Hills, Pennsylvania, 미국, 15025
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Rhode Island
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Warwick, Rhode Island, 미국, 02886
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Tennessee
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Jackson, Tennessee, 미국, 38305
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Utah
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Salt Lake City, Utah, 미국, 84109
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Salt Lake City, Utah, 미국, 84124
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Springville, Utah, 미국, 84663
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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
예
연구 대상 성별
모두
설명
Inclusion Criteria :
- Healthy adults aged 18 years or older on the day of inclusion
- Informed consent has been signed and dated
- Able to attend all scheduled visits and comply with all trial procedures
- For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.
Exclusion Criteria :
- Known pregnancy or positive urine pregnancy test
- Currently breastfeeding a child
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for the inactivated seasonal influenza vaccine, within two weeks preceding trial vaccination
- Planned receipt of any vaccine prior to the Day 42 blood sample
- Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Chronic illness that in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator
- Previous participation in a swine-origin A/H1N1 pandemic flu trial except if performed in 1976
- Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
- Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C ]) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
- Personal or family history of Guillain-Barré syndrome
- Active neoplastic disease or a history of any hematologic malignancy
- Known seizure/epilepsy history and/or taking anti-seizure medication
- Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
- Any Grade 1, 2, or 3 liver function values (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and Alkaline phosphatase) observed in blood sample taken at Screening
- Any Grade 2 or Grade 3 laboratory abnormalities in blood sample taken at Screening
- Receipt of any monovalent 2009 pandemic H1N1 vaccine.
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 |
|---|---|
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실험적: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1 (with adjuvant)
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0.5 mL, Intramuscular on Day 0
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실험적: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant)
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0.5 mL, Intramuscular on Day 0
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활성 비교기: A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 vaccine formulation 3
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0.5 mL, Intramuscular on Day 0
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활성 비교기: A/H1N1 Vaccine Group 4
Participants will receive A/H1N1 vaccine formulation 4
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0.5 mL, Intramuscular on Day 0
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위약 비교기: Placebo Group 5
Participants will receive a placebo vaccine
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0.5 mL, Intramuscular on Day 0
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
기간: Day 0 and Day 21 post-vaccination
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Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.
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Day 0 and Day 21 post-vaccination
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Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
기간: Day 0 and Day 21 post-vaccination
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Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Seroprotection was defined as a titer ≥ 40 (1/dil).
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Day 0 and Day 21 post-vaccination
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Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
기간: Day 0 and Day 21 post-vaccination
|
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
|
Day 0 and Day 21 post-vaccination
|
|
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
기간: Day 0 and Day 21 post-vaccination
|
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
|
Day 0 and Day 21 post-vaccination
|
|
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
기간: Day 0 and Day 21 post-vaccination
|
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Seroprotection was defined as a titer ≥ 40 (1/dil).
|
Day 0 and Day 21 post-vaccination
|
|
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
기간: Day 0 and Day 21 post-vaccination
|
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
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Day 0 and Day 21 post-vaccination
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Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
기간: Day 0 up to Day 7 post-vaccination
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Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis.
Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
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Day 0 up to Day 7 post-vaccination
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Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
기간: Day 0 up to Day 7 post-vaccination
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Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis.
Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
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Day 0 up to Day 7 post-vaccination
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
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 10월 1일
기본 완료 (실제)
2010년 12월 1일
연구 완료 (실제)
2011년 3월 1일
연구 등록 날짜
최초 제출
2009년 8월 3일
QC 기준을 충족하는 최초 제출
2009년 8월 3일
처음 게시됨 (추정)
2009년 8월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 10월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 8월 26일
마지막으로 확인됨
2011년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FUF16
- UTN: U1111-1111-4882
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. .