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A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above

2018년 8월 9일 업데이트: GlaxoSmithKline

A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

119

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 독일
    • Sachsen
      • Dresden, Sachsen, 독일, 01309
        • GSK Investigational Site
      • Dresden, Sachsen, 독일, 01097
        • GSK Investigational Site
      • Dresden, Sachsen, 독일, 01099
        • GSK Investigational Site
      • Dresden, Sachsen, 독일, 01129
        • 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 이상 (성인, 고령자)

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.
  • A male or female aged 18 years or above at the time of vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
  • 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, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
  • Administration of an influenza vaccine within the six months preceding the study vaccination.
  • Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period.
  • Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
  • Acute disease and/or fever at the time of enrolment.
  • Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Chronic underlying disease, not stabilized or clinically serious.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of Guillain-Barré syndrome.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Anaphylaxis following the administration of vaccine(s).
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating 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: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Fluarix/Influsplit 18-60 Years Group
Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
생물학적: Fluarix/Influsplit SSW 2012-2013
1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
실험적: Fluarix/Influsplit > 60 Years Group
Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
생물학적: Fluarix/Influsplit SSW 2012-2013
1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains
기간: At Day 0 and Day 21
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).
At Day 0 and Day 21
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
기간: At Day 0 and Day 21
Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.
At Day 0 and Day 21
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
기간: At Day 21
A seroconverted subjects was defined as a vaccinee 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.
At Day 21
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
기간: At Day 21
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0.
At Day 21
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.
기간: At Day 21
SPP was defined as the number of vaccinees with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.
At Day 21

2차 결과 측정

결과 측정
측정값 설명
기간
Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
기간: At Day 0 and Day 21
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included H1N1, H3N2 and Yamagata antigens. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged greater than (>) 60 years.
At Day 0 and Day 21
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
기간: At Day 0 and Day 21
Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40. The outcome measure was assessed by the influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.
At Day 0 and Day 21
Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
기간: At Day 21
SCR was defined as the number of vaccinees 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 4-fold increase in post-vaccination titer. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.
At Day 21
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
기간: At Day 21
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. This outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.
At Day 21
Duration of Solicited Local Symptoms.
기간: During the 4-day follow-up period (Days 0-3) after vaccination
Duration was defined as number of days with any grade of local symptoms.
During the 4-day follow-up period (Days 0-3) after vaccination
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
기간: During the 4-day (Day 0-Day 3) follow-up period after vaccination
Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.
During the 4-day (Day 0-Day 3) follow-up period after vaccination
Duration of Solicited General Symptoms.
기간: During the 4-day follow-up period (Days 0-3) after vaccination
Duration was defined as number of days with any grade of general symptoms.
During the 4-day follow-up period (Days 0-3) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
기간: During the 4-day follow-up period (Day 0-3) after vaccination

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.

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. Grade 3 fever = axillary temperature above 39.0°C
During the 4-day follow-up period (Day 0-3) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
기간: During the 21-day follow-up period (Days 0-20) after vaccination
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. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
During the 21-day follow-up period (Days 0-20) after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
기간: During the entire study period (Days 0-21)
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.
During the entire study period (Days 0-21)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

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 7월 10일

기본 완료 (실제)

2012년 7월 31일

연구 완료 (실제)

2012년 7월 31일

연구 등록 날짜

최초 제출

2012년 5월 24일

QC 기준을 충족하는 최초 제출

2012년 5월 24일

처음 게시됨 (추정)

2012년 5월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 9월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 9일

마지막으로 확인됨

2013년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 116663
  • 2012-000789-39 (EudraCT 번호)

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. .

Fluarix/Influsplit SSW 2012-2013에 대한 임상 시험

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위치

3
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