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Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

2017년 7월 31일 업데이트: GlaxoSmithKline

Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

210

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 스페인
      • Bilbao, 스페인, 48013
        • GSK Investigational Site
      • Burgos, 스페인, 09005
        • GSK Investigational Site
      • Madrid, 스페인, 28046
        • GSK Investigational Site
      • Móstoles/Madrid, 스페인, 28935
        • GSK Investigational Site
      • Sevilla, 스페인, 41013
        • 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

3년 (어린이)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
  • Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
  • Healthy children as established by medical history and clinical examination when entering into the study.
  • Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • Clinically or virologically confirmed influenza infection within six months preceding the study start.
  • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
  • Acute disease and/or fever at the time of enrolment
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • Previous administration of any H1N1 A/California-like vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
  • Any known or suspected allergy to any constituent of influenza vaccines;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 use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
  • 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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 그룹 A
생물학적: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections and a booster IM injection

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
기간: At Day 0
The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
At Day 0
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
기간: At Day 42
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
At Day 42
Titers for Serum HI Antibodies
기간: At Day 0
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Day 0
Titers for Serum HI Antibodies
기간: At Day 42
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
기간: At Day 42
A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
기간: At Day 42
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Seroconversion Factor (SCF) for HI Antibody Titers
기간: At Day 42
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
At Day 42

2차 결과 측정

결과 측정
측정값 설명
기간
임의 및 등급 3 요청된 국소 증상이 있는 피험자의 수
기간: 백신 접종 후 7일(0-6일) 기간 동안 각 용량 및 용량에 걸쳐
평가된 요청된 국소 증상은 통증, 발적 및 부종이었습니다. Any = 강도 등급에 관계없이 증상의 발생. 3도 통증 = 정상적인 활동을 방해하는 통증. 3등급 발적/부기 = 주사 부위 50밀리미터(mm)를 넘어 확산되는 발적/부기.
백신 접종 후 7일(0-6일) 기간 동안 각 용량 및 용량에 걸쳐
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
기간: At Days 0, 21, 42 and at Month 12
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Titers for Serum HI Antibodies
기간: At Days 0, 21, 42 and at Month 12
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
기간: At Days 21, 42 and at Month 12
A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.
At Days 21, 42 and at Month 12
Number of Seroprotected Subjects in Terms of HI Antibodies
기간: At Days 0, 21, 42 and at Month 12
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Seroconversion Factor (SCF) for HI Antibody Titers
기간: At Days 21, 42 and at Month 12
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
At Days 21, 42 and at Month 12
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
기간: At Days 0, 21 and 42
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
At Days 0, 21 and 42
Titers for Serum Neutralizing Antibodies
기간: At Days 0, 21 and 42
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).
At Days 0, 21 and 42
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
기간: At Month 12
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
At Month 12
Titers for Serum Neutralizing Antibodies
기간: At Month 12
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was Flu A/Neth/602/09.
At Month 12
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
기간: At Days 21 and 42
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
At Days 21 and 42
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
기간: At Month 12
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
At Month 12
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
기간: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever [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 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
기간: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever [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 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any Medically-attended Events (MAEs)
기간: During the entire study period (from Day 0 up to Month 12)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
기간: During the entire study period (from Day 0 up to Month 12)
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 (from Day 0 up to Month 12)
Number of Subjects With Normal or Abnormal Biochemical Levels
기간: At Days 0, 21 and 42
Among biochemical parameters assessed were alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], bilirubin [BILI], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
At Days 0, 21 and 42
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
기간: During the 21-day (Days 0-20) follow-up period after the first 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 the 21-day (Days 0-20) follow-up period after the first vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
기간: During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period 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 the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
Number of Subjects With Serious Adverse Events (SAEs)
기간: During the entire study period (from Day 0 up to Month 12)
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 (from Day 0 up to Month 12)

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.

일반 간행물

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

2009년 9월 10일

기본 완료 (실제)

2010년 11월 27일

연구 완료 (실제)

2010년 11월 27일

연구 등록 날짜

최초 제출

2009년 8월 20일

QC 기준을 충족하는 최초 제출

2009년 8월 20일

처음 게시됨 (추정)

2009년 8월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 2월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 7월 31일

마지막으로 확인됨

2016년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 113528

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. 통계 분석 계획
    정보 식별자: 113528
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  2. 주석이 달린 사례 보고서 양식
    정보 식별자: 113528
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  3. 정보에 입각한 동의서
    정보 식별자: 113528
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  4. 임상 연구 보고서
    정보 식별자: 113528
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  5. 개별 참가자 데이터 세트
    정보 식별자: 113528
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  6. 연구 프로토콜
    정보 식별자: 113528
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  7. 데이터 세트 사양
    정보 식별자: 113528
    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. .

Pandemic influenza vaccine GSK2340272A에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Equatorial Guinea

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다