이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

2019년 8월 2일 업데이트: Novartis Vaccines

A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.

연구 개요

연구 유형

중재적

등록 (실제)

1200

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Panevezys, 리투아니아
        • 2nd Department of Internal Diseases, Panevezys Hospital,
      • Vilnius, 리투아니아
        • Dept. Infectious Diseases and Microbiology of Vilnius University

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 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. 18 to <61 years of age
  2. mentally competent to understand the nature, the scope and the consequences of the study
  3. able and willing to give written informed consent prior to study entry
  4. in good health as determined by:

    1. medical history,
    2. physical examination,
    3. clinical judgment of the Investigator.

Exclusion Criteria:

  1. unwilling or unable to give written informed consent to participate in the study
  2. participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
  3. currently experiencing an acute infectious disease
  4. any serious disease, such as, for example:

    1. cancer,
    2. autoimmune disease (including rheumatoid arthritis),
    3. advanced arteriosclerotic disease or complicated diabetes mellitus,
    4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
    5. acute or progressive hepatic disease,
    6. acute or progressive renal disease,
    7. congestive heart failure
  5. surgery planned during the study period
  6. bleeding diathesis
  7. history of hypersensitivity to any component of the study medication or chemically related substances
  8. history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
  9. known or suspected impairment/alteration of immune function, for example resulting from:

    1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
    2. receipt of immunostimulants,
    3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
    4. high risk for developing an immunocompromising disease
  10. history of drug or alcohol abuse
  11. laboratory-confirmed influenza disease within 6 months prior to Visit 1
  12. receipt of influenza vaccine within 6 months prior to Visit 1
  13. receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
  14. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
  15. if female, pregnant or breastfeeding
  16. if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
  17. planned relocation abroad during the study period
  18. any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

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
실험적: cTIV_lot 1
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
실험적: cTIV_lot 2
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
실험적: cTIV_lot 3
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3
활성 비교기: TIV group
One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
기간: Day 22 postvaccination

The haemagglutinin Inhibition (HI) antibody titer response following

  1. one dose of cTIV for each of the three lots separately and
  2. one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs).

The HI GMTs were evaluated using egg-derived antigen assay.

Day 22 postvaccination
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
기간: Day 22 postvaccination

Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5.

Day 22 postvaccination
Percentage of Subjects With HI Titers ≥40
기간: Day 22 postvaccination

Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%.

Day 22 postvaccination
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine
기간: Day 22 postvaccination

Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is >40%.

As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination.

Day 22 postvaccination

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
기간: Day 1 to Day 7 postvaccination

To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV.
Day 1 to Day 7 postvaccination
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
기간: Day 1 - Day 181 postvaccination
Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.
Day 1 - Day 181 postvaccination

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 의자: Novartis Vaccines, Novartis Vaccines & Diagnostics

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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

2005년 9월 1일

기본 완료 (실제)

2005년 10월 1일

연구 완료 (실제)

2006년 4월 1일

연구 등록 날짜

최초 제출

2006년 4월 3일

QC 기준을 충족하는 최초 제출

2006년 4월 3일

처음 게시됨 (추정)

2006년 4월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 8월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 8월 2일

마지막으로 확인됨

2019년 8월 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. .

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