Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging 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 Children and Adults Ages 3 to 64 Years
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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San Jose, 코스타리카
- Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children, adolescents, and adults 3 to 64 years of age 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.
For additional entry criteria, please refer to protocol.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 2x7.5adj
Two doses of MF59 adjuvanted (adj) A/H1N1
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MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
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실험적: 7.5adj_1_8
MF59 adjuvanted (adj) A/H1N1 on days 1 and 8
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MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
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실험적: 7.5adj_1_22
MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22
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MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
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실험적: 15_1_22
A/H1N1 on study days 1 and 22
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Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
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실험적: 2x15_1_22
Two doses of A/H1N1 (one in each arm) on study days 1 and 22
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Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
기간: Day 1 to day 387
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Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
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Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
기간: Day 1 to day 387
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Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS). |
Day 1 to day 387
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Age Distribution at Baseline
기간: Baseline
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Baseline
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Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
기간: Day 1 to day 387
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Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
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HI GMRs, in 3 to <9 Years and 9 to 17 Years
기간: Day 1 to day 387
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Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS). |
Day 1 to day 387
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HI GMR, in Adults 18 to 64 Years
기간: Day 1 to day 387
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Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
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Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
기간: 7 days and 21 days after each vaccination
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Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS). |
7 days and 21 days after each vaccination
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Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
기간: 7 days after each vaccination
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Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination |
7 days after each vaccination
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Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
기간: 7 days after each vaccination
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Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination. |
7 days after each vaccination
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Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
기간: 7 days after each vaccination
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Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set. |
7 days after each vaccination
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공동 작업자 및 조사자
수사관
- 연구 책임자: Novartis Vaccines, Novartis Vaccines
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
소설 2009 인플루엔자 H1N1에 대한 임상 시험
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University of RochesterNational Institutes of Health (NIH)빼는
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David ScheifeleCanadian Institutes of Health Research (CIHR); PHAC/CIHR Influenza Research Network완전한
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University of RochesterNational Institutes of Health (NIH)완전한
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Fluart Innovative Vaccine Ltd, Hungary완전한
MF59-eH1N1_f에 대한 임상 시험
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SeqirusNovartis Vaccines완전한
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SeqirusDepartment of Health and Human Services모병감염 | 바이러스 질환 | 호흡기 감염 | 인플루엔자, 인간 | 감염 바이러스필리핀 제도, 미국
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Sanofi Pasteur, a Sanofi Company완전한
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The University of QueenslandSyneos Health; Coalition for Epidemic Preparedness Innovations모집하지 않고 적극적으로
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HIV Vaccine Trials NetworkSouth Africa AIDS Vaccine Initiative완전한
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National Institute of Allergy and Infectious Diseases...GlaxoSmithKline; Bill and Melinda Gates Foundation; Medical Research Council; Sanofi Pasteur... 그리고 다른 협력자들완전한
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Biomedical Advanced Research and Development AuthorityPPD완전한
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National Institute of Allergy and Infectious Diseases...Novartis Vaccines; HIV Vaccine Trials Network; IPPOX Foundation완전한