- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01730378
Immunogenicity and Safety of PrepandrixTM in Korean Subjects Aged 18 to 60 Years Old
2018년 8월 9일 업데이트: GlaxoSmithKline
Immunogenicity and Safety of GlaxoSmithKline Biologicals' (Pre-) Pandemic Influenza Vaccine Prepandrix™ in Korean Subjects Aged 18 to 60 Years Old
This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean subjects.
A second group of subjects will receive FluarixTM vaccine as control.
연구 개요
상세 설명
Initially, 124 subjects were planned to be enrolled according to a 1:1 randomisation ratio. However, by mistake, the randomisation application was set up consistent with the vaccine supply ratio (2:1) rather than the treatment group randomization ratio (1:1). Subsequently, the protocol was amended to adjust the sample size and randomisation ratio for the study.
The study will enrol 126 subjects randomised 2:1. 84 subjects will receive Prepandrix™ and 42 subjects will receive Fluarix™.
연구 유형
중재적
등록 (실제)
131
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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Guro Gu, 대한민국, 152703
- GSK Investigational Site
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Gyeonggi, 대한민국, 442-723
- GSK Investigational Site
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Incheon, 대한민국, 400-711
- GSK Investigational Site
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Seoul, 대한민국, 150-950
- 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. Or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- Korean male or female subject between, and including, 18 and 60 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject/ from the parent(s)/ Legally Acceptable Representative(s).
- Healthy subjects or free of acute aggravation of the health status as established by medical history and clinical examination before entering into the study.
- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Acute disease and/or fever at the time of enrollment.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Diagnosed with cancer, or treatment for cancer, within the past three years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including history of human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without any clinically-apparent bleeding tendency, are eligible.
- History of any neurological disorders or seizures.
- An acute evolving neurological disorder or history of Guillan-Barré syndrome.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any administration of long-acting immune-modifying drugs within three months before study start, or a planned administration during the study period.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Clinically or virologically diagnosed influenza infection within six months preceding the study start.
- Administration of any vaccines within 30 days before vaccination, or planned administration during the study start.
- Previous vaccination against influenza with any seasonal or pandemic vaccine within six months preceding the administration of the study vaccine.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- History of allergy or reactions likely to be exacerbated by any component of the vaccines, including history of a severe adverse reaction to a previous dose of influenza vaccine.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Child in care.
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Prepandrix Group
Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21.
The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
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2 doses administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
다른 이름들:
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활성 비교기: Fluarix Group
Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
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1 dose administered intramuscularly in the deltoid region of non-dominant arm.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
기간: At Day 42
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A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
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At Day 42
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Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
기간: At Day 42
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MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).
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At Day 42
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Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
기간: At Day 42
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A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.
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At Day 42
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Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
기간: At Day 0 and Day 42
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Antibody titers were expressed as Geometric mean titers (GMTs).
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At Day 0 and Day 42
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
기간: At Day 21
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Antibody titers were expressed as Geometric mean titers (GMTs).
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At Day 21
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Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
기간: At Day 0 and Day 21
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A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.
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At Day 0 and Day 21
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Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
기간: At Day 21
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A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
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At Day 21
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Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
기간: At Day 21
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MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).
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At Day 21
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Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
기간: At Days 0 and 21
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Antibody titers were expressed as Geometric mean titers (GMTs).
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).
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At Days 0 and 21
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Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
기간: At Day 21
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A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).
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At Day 21
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Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
기간: At Day 21
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MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).
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At Day 21
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Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
기간: At Day 0 and Day 21
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A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).
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At Day 0 and Day 21
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
기간: During the 7-day (Day 0-6) period after each vaccination
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Solicited local symptoms assessed were pain, redness and swelling.
Any was defined as any solicited local symptom reported irrespective of intensity.
Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school.
Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.
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During the 7-day (Day 0-6) period after each vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
기간: During the 7-day (Days 0-6) post-vaccination period
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Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0
degrees Celsius (°C)].
Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination.
Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider.
Grade 3 fever = axillary temperature above 39.0°C
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs).
기간: During the entire study period (From Day 0 to Day 182)
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Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
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During the entire study period (From Day 0 to Day 182)
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Number of Subjects Reporting Unsolicited Adverse Events (AEs)
기간: During the 21 days (Day 0-20) post-vaccination period
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Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
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During the 21 days (Day 0-20) post-vaccination period
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Number of Subjects Reporting Unsolicted AEs
기간: During the 84-day (Days 0-83) post vaccination period
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Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
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During the 84-day (Days 0-83) post vaccination period
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Number of Subjects Any Unsolicited AEs
기간: During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group
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Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
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During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
기간: During the entire study period (From Day 0 to 182)
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A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
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During the entire study period (From Day 0 to 182)
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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
2012년 12월 5일
기본 완료 (실제)
2013년 12월 17일
연구 완료 (실제)
2013년 12월 17일
연구 등록 날짜
최초 제출
2012년 11월 15일
QC 기준을 충족하는 최초 제출
2012년 11월 15일
처음 게시됨 (추정)
2012년 11월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 9월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 8월 9일
마지막으로 확인됨
2016년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 114695
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. .
Prepandrix™에 대한 임상 시험
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Andrew ParrentUniversity of Western Ontario, Canada; Synaptive Medical알려지지 않은
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London Health Sciences CentreUniversity of Western Ontario, Canada; Synaptive Medical알려지지 않은뇌 손상, 만성 | Cerebellar Cognitive Affective Syndrome | 소뇌 함묵증
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Boston Scientific Corporation완전한일시적 허혈 발작 | 혈전색전성 뇌졸중 | 뇌졸중 예방미국, 아르헨티나, 독일
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CereVasc IncAlvaMed, Inc.; Simplified Clinical Data Systems, LLC; Bioscience Consulting, Inc.모병
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Medtronic Cardiovascular모집하지 않고 적극적으로대 동맥류독일, 뉴질랜드, 미국, 네덜란드, 스위스, 영국, 스페인, 호주, 이탈리아, 스웨덴, 프랑스, 오스트리아, 슬로바키아
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Asklepios Kliniken Hamburg GmbHUniversity of Kiel완전한기도 관리 | 후두 마스크 기도 | 광섬유 삽관법
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GlaxoSmithKline완전한파상풍 | 디프테리아 | 무세포 백일해 | 소아마비 | B형 헤모필루스 인플루엔자대한민국
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GlaxoSmithKline완전한