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A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary

2019년 11월 15일 업데이트: GlaxoSmithKline

Seroprevalence of Bordetella Pertussis in Adults in Hungary

The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

The protocol posting was amended to correct the detailed title. Since a sample of blood will be collected from all subjects (outside of routine hospital procedure), the study does not meet GSK's definition of an observational study and hence the term "observational" was deleted from the detailed title.

연구 유형

중재적

등록 (실제)

2000

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 헝가리
      • Budapest, 헝가리, 1136
        • GSK Investigational Site
      • Budapest, 헝가리, 1182
        • GSK Investigational Site
      • Debrecen, 헝가리, 4027
        • GSK Investigational Site
      • Kecskemét, 헝가리, 6000
        • GSK Investigational Site
      • Zirc, 헝가리, 8420
        • 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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent will be obtained from subjects prior to performing any study procedures.
  • Males or females ≥ 18 years of age at the time of enrollment.
  • Agreeing to collection of a blood sample for the study.

Exclusion Criteria:

• Confirmed or suspected immunological disorder.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

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

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Study Group
Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
절차: Blood sampling
A blood sample (2.5 mL) will be collected from all subjects
다른: Data collection
Active questioning

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
기간: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 Optical Density (OD) units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations
기간: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)
기간: At the time of enrollment of each subject (Day 0).
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units).
At the time of enrollment of each subject (Day 0).
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)
기간: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)
기간: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)
기간: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)
기간: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)
기간: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
기간: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
기간: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
기간: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
기간: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)
기간: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)
기간: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (<) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)
기간: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)
기간: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (<) 1.0 OD units. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
기간: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
기간: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization)
기간: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)

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

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 (실제)

2014년 4월 24일

기본 완료 (실제)

2015년 4월 22일

연구 완료 (실제)

2015년 4월 24일

연구 등록 날짜

최초 제출

2013년 12월 12일

QC 기준을 충족하는 최초 제출

2013년 12월 12일

처음 게시됨 (추정)

2013년 12월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 11월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 11월 15일

마지막으로 확인됨

2019년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 116804

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

IPD for this study will be made available via the Clinical Study Data Request site.

IPD 공유 기간

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD 공유 액세스 기준

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

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. .

백일해에 대한 임상 시험

Blood sampling에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Morocco

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다