Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate
2018년 5월 9일 업데이트: GlaxoSmithKline
A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years and Above.
The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
연구 개요
상세 설명
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
연구 유형
중재적
등록 (실제)
678
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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Elverum, 노르웨이, 2408
- GSK Investigational Site
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Hamar, 노르웨이, 2301
- GSK Investigational Site
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Paradis, 노르웨이, 5231
- GSK Investigational Site
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Stavanger, 노르웨이, 4010
- 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
60년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials.
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of confirmed influenza infection within the last 12 months.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute disease at the time of enrolment.
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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활성 비교기: Fluarix Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study.
The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
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Single dose, intramuscular injection
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실험적: GSK1247446A Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study.
The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
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Single dose, intramuscular injection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
기간: During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited local symptoms were ecchymosis, pain, redness and swelling.
Any = Incidence of a particular solicited local symptom regardless of intensity grade.
Grade 3 pain = Pain that prevented normal everyday activity.
Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
기간: During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering.
Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination.
Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C).
Grade 3 symptom = Symptom that prevented normal activity.
Grade 3 fever = Axillary temperature > 39.0°C.
Related = Symptom considered by the investigator to have a causal relationship to study vaccination.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
기간: During the 30-day (Days 0-29) 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 = Any unsolicited AE regardless of intensity or relationship to vaccination.
Grade 3 = Unsolicited AE that prevented normal activity.
Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.
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During the 30-day (Days 0-29) post vaccination period
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Number of Subjects With Any and Related Serious Adverse Events (SAEs).
기간: During the entire study period (from Day 0 to Day 29)
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.
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During the entire study period (from Day 0 to Day 29)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
기간: At Day 21
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 21
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Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
기간: At Day 0 and Day 21
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A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 0 and Day 21
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
기간: At Day 21
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The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 21
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
기간: At Day 0 and Day 21
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Titers are presented as geometric mean titers (GMTs).
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
The seropositivity cut-off assay was 1:10.
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At Day 0 and Day 21
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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
2006년 10월 20일
기본 완료 (실제)
2007년 2월 1일
연구 완료 (실제)
2007년 2월 5일
연구 등록 날짜
최초 제출
2006년 10월 10일
QC 기준을 충족하는 최초 제출
2006년 10월 10일
처음 게시됨 (추정)
2006년 10월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 6월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 5월 9일
마지막으로 확인됨
2016년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 108708
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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개별 참가자 데이터 세트
정보 식별자: 108708정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 108708정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 108708정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 108708정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 108708정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: 108708정보 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. .
FluarixTM에 대한 임상 시험
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