Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children
2018년 8월 22일 업데이트: GlaxoSmithKline
Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine GSK2321138A in Healthy Children
The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.
연구 개요
연구 유형
중재적
등록 (실제)
599
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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Mexico city, 멕시코, 04530
- GSK Investigational Site
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Estado De México
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Ecatepec de Morelos, Estado De México, 멕시코, 55075
- 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
1년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
For all subjects:
- Subjects who the investigator believes that they and/or their Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject/from the LAR(s).
For unprimed subjects:
- A male or female child aged 18 to 47 months at the time of the first vaccination.
- Children who did not have influenza vaccine in a previous season.
For primed subjects from study NCT00764790:
• Children who received Fluarix™ in the 111751 study NCT00764790.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- History of hypersensitivity to any vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Acute disease at the time of enrolment.
- History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
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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실험적: GSK2321138A Group
Subjects aged between 18 and 47 months received the GSK2321138A.
"Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28.
The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
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Intramuscular injection
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활성 비교기: Fluarix Group
Subjects aged between 18 and 47 months received the Fluarix™ vaccine.
"Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28.
The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
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Intramuscular injection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
기간: At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]
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Titers are presented as geometric mean titers (GMTs).
The reference cut-off value was 1:10.
The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.
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At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
기간: At Days 0 and 28.
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Titers are presented as geometric mean titers (GMTs).
The reference cut-off value was 1:10.
The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the primed groups.
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At Days 0 and 28.
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
기간: At Days 0, 28 and Day 56
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Titers are presented as geometric mean titers (GMTs).
The reference cut-off value was 1:10.
The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the unprimed groups.
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At Days 0, 28 and Day 56
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Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
기간: At Days 0 and 28
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A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10.
The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the primed groups.
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At Days 0 and 28
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Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
기간: At Days 0, 28 and 56
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A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10.
The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the unprimed groups.
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At Days 0, 28 and 56
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Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
기간: At Day 28
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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 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the primed groups.
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At Day 28
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Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
기간: At Days 28 and 56
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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 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the unprimed groups.
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At Days 28 and 56
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
기간: At Day 28
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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 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the primed groups.
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At Day 28
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
기간: At Days 28 and 56
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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 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the unprimed groups.
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At Days 28 and 56
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Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
기간: At Days 0 and 28
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A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the primed groups.
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At Days 0 and 28
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Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
기간: At Days 0, 28 and 56
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A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the unprimed groups.
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At Days 0, 28 and 56
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
기간: During the 7-day follow-up period (Days 0 to 6) after any vaccination
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Assessed solicited local symptoms were pain, redness and swelling at the injection site.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = cried when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
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During the 7-day follow-up period (Days 0 to 6) after any vaccination
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
기간: During the 7-day follow-up period (Days 0 to 6) after any vaccination
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Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius).
For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination.
Related = symptoms assessed by the investigator as related to vaccination.
Grade 3 drowsiness = prevented normal activity.
Grade 3 loss of appetite = not eating at all.
Grade 3 irritability= crying that could not be comforted/prevented normal activity.
Grade 3 temperature: ≥ 39.0°C.
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During the 7-day follow-up period (Days 0 to 6) after any vaccination
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
기간: During the 28-day follow-up period (Days 0 to 27) after vaccination
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An unsolicited AE covers any untoward medical occurrence in a 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 = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to vaccination.
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During the 28-day follow-up period (Days 0 to 27) after vaccination
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Number of Subjects With Any and Related Serious Adverse Events (SAEs).
기간: From Day 0 to Day 180 (study conclusion)
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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.
Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.
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From Day 0 to Day 180 (study conclusion)
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Number of Subjects With Any Adverse Events of Specific Interest (AESIs).
기간: From Day 0 to Day 180 (study conclusion)
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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.
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From Day 0 to Day 180 (study conclusion)
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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
2009년 10월 8일
기본 완료 (실제)
2010년 5월 21일
연구 완료 (실제)
2010년 5월 21일
연구 등록 날짜
최초 제출
2009년 9월 24일
QC 기준을 충족하는 최초 제출
2009년 9월 24일
처음 게시됨 (추정)
2009년 9월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 9월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 8월 22일
마지막으로 확인됨
2016년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 113237
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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정보에 입각한 동의서
정보 식별자: 113237정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 113237정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 113237정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 113237정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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개별 참가자 데이터 세트
정보 식별자: 113237정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 113237정보 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. .