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Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate

2018년 5월 9일 업데이트: GlaxoSmithKline

A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidates Compared to Fluarix™ Administered Intramuscularly in Subjects Aged 18-59 Years.

The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

300

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 벨기에
      • Wilrijk, 벨기에, 2610
        • GSK Investigational Site

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:

  • A male or female aged 18-59 years at the time of the first vaccination.
  • Free of obvious health problems

Exclusion Criteria:

  • Use of non-registered products
  • Administration of immune-modifying drugs.
  • Administration of vaccine 30 days before enrolment in study.
  • Immunosuppressive or immunodeficient condition.
  • Hypersensitivity to a previous dose of influenza vaccine
  • Previous vaccination against influenza in 2006
  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
  • History of confirmed influenza infection within the last 12 Months.
  • Acute disease at the time of enrolment/vaccination.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine

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: GSK1247446A Formulation 1 Group
Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
생물학적: GSK1247446A
Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
실험적: GSK1247446A Formulation 2 Group
Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
생물학적: GSK1247446A
Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
활성 비교기: Fluarix Group
Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
생물학적: Fluarix™
GlaxoSmithKline Biologicals' licensed influenza vaccine

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.
기간: At Day 0 and at Day 21.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.
At Day 0 and at Day 21.
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.
기간: At Day 0 and at Day 21.
A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).
At Day 0 and at Day 21.
Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed
기간: At Day 21.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.
At Day 21.
Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.
기간: At Day 21.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).
At Day 21.

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
기간: Within the 7-day follow-up period (Days 0-6) after vaccination
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.
Within the 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
기간: Within the 7-day follow-up period (Days 0-6) after vaccination
Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.
Within the 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
기간: Within the 30-day follow-up period (Days 0-29) after vaccination
An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.
Within the 30-day follow-up period (Days 0-29) after vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
기간: From study start to study end, from Day 0 to Day 30
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 = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
From study start to study end, from Day 0 to Day 30

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

간행물 및 유용한 링크

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

유용한 링크

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 3일

기본 완료 (실제)

2006년 11월 1일

연구 완료 (실제)

2006년 11월 30일

연구 등록 날짜

최초 제출

2006년 9월 8일

QC 기준을 충족하는 최초 제출

2006년 9월 8일

처음 게시됨 (추정)

2006년 9월 12일

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

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 108656

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

  1. 개별 참가자 데이터 세트
    정보 식별자: 108656
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  2. 데이터 세트 사양
    정보 식별자: 108656
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  3. 연구 프로토콜
    정보 식별자: 108656
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  4. 정보에 입각한 동의서
    정보 식별자: 108656
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  5. 임상 연구 보고서
    정보 식별자: 108656
    정보 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. .

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