Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults
2019년 3월 25일 업데이트: SK Chemicals Co., Ltd.
Randomized, Double-blinded, Controlled, Phase I Trial to Assess Safety, Tolerability and Immunogenicity of 'NBP607(Trivalent Inactivated Cell-Culture Influenza Vaccine)' Compared to Egg-based Influenza Vaccine in Healthy Adult
A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers
연구 개요
상세 설명
- Assessment of Safety
- Assessment of Immunogenicity
- Estimated Enrollment: 100
연구 유형
중재적
등록 (실제)
100
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Guro-gu
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Seoul, Guro-gu, 대한민국, 153-703
- Korea University Guro Hospital
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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
20년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- 20 to <60 years of age
- able and willing to give written informed consent prior to study entry
- if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
Exclusion Criteria:
- hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Immunodeficiency disease
- history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
- thrombocytopenia or Coagulation disorders
- experienced fever (>37.5°C) within the past 24 hours or any acute respiratory infection
- receipt of Immunosuppressants or Immunomodulators within the past 3 months
- receipt of blood products or immunoglobulin within the past 3 months
- received influenza vaccine within the past 6 months
- received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
- participation on another clinical trial within 1 month prior to the study vaccination
- history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
- any chronic diseases that interfere with the clinical trial or Malignant tumors
- pregnant or breastfeeding
- any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
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: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group 1
NBP607 0.5ml
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1 dose, 0.5ml, Intramuscular (IM) injection
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활성 비교기: Group 2
Agrippal 0.5ml
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1 dose, 0.5ml, Intramuscular (IM) injection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence rate of solicited local adverse events (AEs)
기간: Within 21 days after vaccination
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All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
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Within 21 days after vaccination
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Incidence rate of solicited systemic AEs
기간: Within 21 days after vaccination
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All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
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Within 21 days after vaccination
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Incidence rate of unsolicited AEs
기간: Within 21 days after vaccination
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All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
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Within 21 days after vaccination
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Pulse rate at each visit
기간: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Blood pressure(systolic/diastolic) at each visit
기간: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Body temperature at each visit
기간: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit
기간: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
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Rate of normal/abnormal results in physical examination at each visit
기간: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit
기간: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]
기간: 21-28 days after vaccination
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The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were <1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer
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21-28 days after vaccination
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Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
기간: 21-28 days after vaccination
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The mean increase in geometric mean HI titer
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21-28 days after vaccination
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Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]
기간: 21-28 days after vaccination
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The proportion of subjects with post-vaccination HI titers of ≥1:40
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21-28 days after vaccination
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Woo Joo Kim, Ph.D., Korea University Guro Hospital
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 9월 1일
기본 완료 (실제)
2012년 10월 1일
연구 완료 (실제)
2012년 11월 1일
연구 등록 날짜
최초 제출
2012년 12월 12일
QC 기준을 충족하는 최초 제출
2019년 3월 25일
처음 게시됨 (실제)
2019년 3월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 3월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 3월 25일
마지막으로 확인됨
2012년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NBP607_Flu_I_2012
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. .