A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk
2019년 6월 13일 업데이트: GlaxoSmithKline
Observer-blind, Post-Marketing Study to Compare the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007-2008 Season) Made With New vs. Aged Bulk Material, in Adults Ranging in Age From 18 to 60 Years
Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.
Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.
Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.
연구 개요
연구 유형
중재적
등록 (실제)
1000
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Quebec, 캐나다, G1W 4R4
- GSK Investigational Site
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British Columbia
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Coquitlam, British Columbia, 캐나다, V3K 3P4
- GSK Investigational Site
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Newfoundland and Labrador
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Bay Roberts, Newfoundland and Labrador, 캐나다, A0A 1G0
- GSK Investigational Site
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Ontario
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Toronto, Ontario, 캐나다, M9W 4L6
- GSK Investigational Site
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Toronto, Ontario, 캐나다, M1L 4S4
- GSK Investigational Site
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Quebec
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Gatineau, Quebec, 캐나다, J8Y 6S8
- GSK Investigational Site
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Sherbrooke, Quebec, 캐나다, J1H 4J6
- GSK Investigational Site
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Sherbrooke, Quebec, 캐나다, J1H 1Z1
- GSK Investigational Site
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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 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Male and female adults, 18 to 60 years.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.
Exclusion Criteria:
- Acute disease at the time of enrollment.
- Any confirmed or suspected immunosuppressive condition
- Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- A history of any demyelinating disease including Guillain-Barré syndrome.
- Presence of an active neurological disorder.
- Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
- Receipt of an influenza vaccine within 6 months prior to study enrollment.
- Administration of any vaccines within 30 days prior to study enrollment or during the study period.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
- Any known or suspected allergy to any constituent of Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
- A history of severe adverse reaction to a previous influenza vaccination.
- Lactating/nursing female.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
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: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Old Bulk
This group receives a full dose of Fluviral made from aged bulk material
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One dose, Intramuscular injection
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활성 비교기: New Bulk
This group receives a full dose of Fluviral made from new material
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One dose, Intramuscular injection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Geometric Mean Titers (GMTs) of Anti-H3 and B Strains
기간: At Day 21
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GMTs for H1 strain is addressed as a secondary endpoint
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At Day 21
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains
기간: At Days 0 and 21
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The table contains GMTs of the H1 strains at Day 0 & 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)
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At Days 0 and 21
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Number of Participants Who Seroconverted.
기간: At Day 21.
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The table shows the number of participants who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a prevaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.
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At Day 21.
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Number of Seroprotected Participants.
기간: At Days 0 and 21
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The table presents the number of participants with a serum haemagglutination inhibition (HI) titer >= 1:40 that usually is accepted as indicating protection.
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At Days 0 and 21
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Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1
기간: At Day 21 compared to Day 0
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Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21.
This table presents the SCF for the H1 strain.
The SCF for the other strains are addressed in the next table.
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At Day 21 compared to Day 0
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The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B
기간: At Day 21 compared to Day 0
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The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table.
The "fold increase" corresponds to the Unit of Measure "Factor."
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At Day 21 compared to Day 0
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Number of Participants Reporting Solicited Local Symptoms
기간: During the 4-day follow up period following vaccination.
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Solicited local symptoms assessed include pain, redness and swelling.
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During the 4-day follow up period following vaccination.
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Number of Participants Reporting Solicited General Symptoms
기간: During the 4-day period following each vaccination.
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Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face
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During the 4-day period following each vaccination.
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Number of Participants Reporting Unsolicited Adverse Events (AE).
기간: During the 21-day period following each vaccination.
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An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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During the 21-day period following each vaccination.
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Number of Participants Reporting Serious Adverse Events (SAE)
기간: Within 21 days after vaccination
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An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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Within 21 days after 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.
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 (실제)
2007년 12월 14일
기본 완료 (실제)
2008년 1월 14일
연구 완료 (실제)
2008년 1월 14일
연구 등록 날짜
최초 제출
2007년 12월 21일
QC 기준을 충족하는 최초 제출
2007년 12월 21일
처음 게시됨 (추정)
2008년 1월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 6월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 6월 13일
마지막으로 확인됨
2019년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 111258
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
연구 데이터/문서
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주석이 달린 사례 보고서 양식
정보 식별자: 111258정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: 111258정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 111258정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 111258정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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개별 참가자 데이터 세트
정보 식별자: 111258정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 111258정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 111258정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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. .