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Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)

2018년 7월 31일 업데이트: GlaxoSmithKline

Immunogenicity and Safety Study of GSK Biologicals' Influenza Candidate Vaccine GSK2340274A

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.

연구 개요

상세 설명

This Protocol Posting has been updated following Protocol amendment 1& 2, October 2009. The sections impacted are study design and outcome measures

연구 유형

중재적

등록 (실제)

100

단계

  • 2 단계

연락처 및 위치

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

연구 장소

      • Fukuoka, 일본, 813-8588
        • GSK Investigational Site
      • Tokyo, 일본, 204-8585
        • 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

20년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive.
  • Good general health as assessed by medical history and physical examination
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • 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.
  • Females of non-childbearing potential may be enrolled in the study.
  • Female of childbearing potential may be enrolled in the study, if she:
  • 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 the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • History of previous administration of a novel [H1N1]v vaccine.
  • Previous participation in study NCT00742885.
  • Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
  • Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Presence of an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Diagnosed with cancer, or treatment for cancer within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
  • Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
  • Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome.
  • Administration of any vaccines within 30 days before vaccination or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182, with the exception of seasonal influenza vaccine.
  • Administration of any seasonal influenza vaccine within 14 days before vaccination on Day 0, or planned administration within the first vaccination up to blood sampling at Day 42 and within 14 days prior to blood sampling at Day 182.
  • Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known pregnancy or a positive urine test result prior to the time of first vaccination.
  • Lactating or nursing female.
  • Excessive underweight (Body Mass Index [BMI] < 18.5) or excessive obesity (BMI >= 30).
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: GSK2340274A GROUP
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Two intramuscular injections on Day 0 and Day 21, respectively

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 0
Titers are presented as geometric mean titers (GMTs).
At Day 0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 21
Titers are presented as geometric mean titers (GMTs).
At Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 42
Titers are presented as geometric mean titers (GMTs).
At Day 42
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 0
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
At Day 0
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 21
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
At Day 21
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 42
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
At Day 42
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
At Day 21
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
At Day 42
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 0
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
At Day 0
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 21
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
At Day 21
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 42
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
At Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 21
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.
At Day 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Day 42
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.
At Day 42

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
기간: At Days 0, 21, 42 and 182
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
At Days 0, 21, 42 and 182
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Days 0, 21, 42 and 182
Titers are presented as geometric mean titers (GMTs).
At Days 0, 21, 42 and 182
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Days 21, 42 and 182
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
At Days 21, 42 and 182
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Days 0, 21, 42 and 182
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
At Days 0, 21, 42 and 182
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
기간: At Days 21, 42 and 182
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.
At Days 21, 42 and 182
Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
기간: At Days 0, 21, 42 and 182
Titers are presented as geometric mean titers (GMTs).
At Days 0, 21, 42 and 182
Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
기간: At Days 0, 21, 42 and 182
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:8.
At Days 0, 21, 42 and 182
Number of Seroconverted Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
기간: At Days 21, 42 and 182
A seroconverted subject was defined as a vaccinated subject with a minimum 4-fold increase in post vaccination neutralizing titer.
At Days 21, 42 and 182
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
기간: During a 7-day (Days 0-6) follow-up after each vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
During a 7-day (Days 0-6) follow-up after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
기간: During a 7-day (Days 0-6) follow-up after each vaccination
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During a 7-day (Days 0-6) follow-up after each vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
기간: During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccination
An unsolicited AE covers 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 and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccination
Number of Subjects With Serious Adverse Events (SAEs)
기간: During the entire study period (Days 0-182)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
During the entire study period (Days 0-182)
Number of Subjects With Any Adverse Events of Specific Interest (AESIs).
기간: During the entire study period (Days 0-182)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
During the entire study period (Days 0-182)
Number of Days With Any Solicited Local Symptoms
기간: During a 7-day (Days 0-6) follow-up after each vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited local symptom was assessed in subjects who have reported at least once the symptom.
During a 7-day (Days 0-6) follow-up after each vaccination
Number of Days With Any Solicited General Symptoms
기간: During a 7-day (Days 0-6) follow-up after each vaccination
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited general symptom was assessed in subjects who have reported at least once the symptom.
During a 7-day (Days 0-6) follow-up after each vaccination

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

2009년 10월 1일

기본 완료 (실제)

2010년 4월 19일

연구 완료 (실제)

2010년 4월 19일

연구 등록 날짜

최초 제출

2009년 10월 1일

QC 기준을 충족하는 최초 제출

2009년 10월 1일

처음 게시됨 (추정)

2009년 10월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 1월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 7월 31일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

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. 임상 연구 보고서
    정보 식별자: 113519
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  2. 통계 분석 계획
    정보 식별자: 113519
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  3. 정보에 입각한 동의서
    정보 식별자: 113519
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  4. 개별 참가자 데이터 세트
    정보 식별자: 113519
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  5. 연구 프로토콜
    정보 식별자: 113519
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  6. 주석이 달린 사례 보고서 양식
    정보 식별자: 113519
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  7. 데이터 세트 사양
    정보 식별자: 113519
    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. .

Influenza investigational vaccine GSK2340274A에 대한 임상 시험

3
구독하다