A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
2015년 9월 20일 업데이트: Seqirus
A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years.
Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
402
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Los Angeles, California, 미국, 90036
- Site 286
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Idaho
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Boise, Idaho, 미국, 83642
- Site 289
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Missouri
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Saint Louis, Missouri, 미국, 63141
- Site 287
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New York
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Binghamton, New York, 미국, 13901
- Site 285
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North Carolina
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Durham, North Carolina, 미국, 27704
- Site 290
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Raleigh, North Carolina, 미국, 27609
- Site 281
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Winston-Salem, North Carolina, 미국, 27103
- Site 280
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South Carolina
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Charleston, South Carolina, 미국, 29403
- Site 284
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Texas
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Austin, Texas, 미국, 78705
- Site 283
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Fort Worth, Texas, 미국, 76135
- Site 282
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San Angelo, Texas, 미국, 76904
- Site 288
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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
5년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Males or females aged 5 to less than 9 years at the time of first study vaccination.
- The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
- In good health, as determined by medical history and a targeted physical examination (if warranted).
Exclusion Criteria:
- Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
- Clinical signs of significant active infection or an elevated oral temperature at study entry.
- A clinically significant medical or psychiatric condition.
- A history of seizures or febrile convulsions or Guillain-Barré syndrome.
- Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
- Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
- Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
- Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
- Currently receiving treatment with warfarin or other anticoagulants.
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: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
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Subjects will receive one or two study vaccinations depending on their influenza vaccine history.
The vaccine will be administered by intramuscular injection.
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활성 비교기: Comparator Quadrivalent Influenza Virus Vaccine
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
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Subjects will receive one or two study vaccinations depending on their influenza vaccine history.
The vaccine will be administered by intramuscular injection.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
기간: 7 days after each administration of vaccine.
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The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV.
A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F).
The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
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7 days after each administration of vaccine.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
기간: 7 days after each administration of vaccine.
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The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine.
A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F).
The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).
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7 days after each administration of vaccine.
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The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
기간: 7 days after each administration of vaccine.
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Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom.
Excludes subjects with missing intensity information for the whole 7 days.
Mild fever: ≥ 100.4 to < 101.3º
F (≥ 38.0 to < 38.5º C).
Moderate fever: ≥ 101.3 to < 102.2º
F (≥ 38.5 to < 39.0º C).
Severe fever: ≥ 102.2º
F (≥ 39.0º C).
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7 days after each administration of vaccine.
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The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
기간: 7 days after each administration of vaccine.
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The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
Percentages for intensity are based on the number of subjects with non-missing intensity data.
Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
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7 days after each administration of vaccine.
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The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
기간: 7 days after each administration of vaccine.
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The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
Percentages for intensity are based on the number of subjects with non-missing intensity data.
Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
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7 days after each administration of vaccine.
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The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
기간: 7 days after each administration of vaccine.
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The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality.
However, subjects can be counted more than once overall.
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7 days after each administration of vaccine.
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The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
기간: 7 days after each administration of vaccine.
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The number of subjects experiencing at least one SAE.
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7 days after each administration of vaccine.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: bioCSL Pty Ltd Clinical Program Director, Seqirus
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
2014년 9월 1일
기본 완료 (실제)
2014년 12월 1일
연구 완료 (실제)
2014년 12월 1일
연구 등록 날짜
최초 제출
2014년 8월 6일
QC 기준을 충족하는 최초 제출
2014년 8월 7일
처음 게시됨 (추정)
2014년 8월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 10월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 9월 20일
마지막으로 확인됨
2015년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CSLCT-USF-10-69
- 2015-000175-27 (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. .