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Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations

2019년 6월 13일 업데이트: GlaxoSmithKline

A Phase IV, Open-Label, Multi-Center Study to Evaluate the Safety and the 1-year Persistence of Antibody Response Among Children Who Received 4 Doses of the GSK MenACWY Conjugate Vaccine at 2, 4, 6 and 12 Months of Age in South Korea

This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will be provided information about the trial. If interested and if eligible, they will then be asked to provide signed informed consent. The initial study visit can occur immediately after signed informed consent has been obtained. Approximately 135 subjects will be enrolled to receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

128

단계

  • 4단계

연락처 및 위치

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

연구 장소

  • 대한민국
      • Ansan si, 대한민국, 425 707
        • GSK Investigational Site
      • Incheon, 대한민국, 400 711
        • GSK Investigational Site
      • Jeonju, 대한민국, 561 712
        • GSK Investigational Site
      • Seongnam si, 대한민국, 463 707
        • GSK Investigational Site
      • Seoul, 대한민국, 110 744
        • GSK Investigational Site
      • Seoul, 대한민국, 158 710
        • 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

2개월 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Healthy male and female 2 month-old infants (55 - 89 days) on the day of consent.
  2. Infants whose parents or legal guardians have voluntary given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
  3. Infants whose parents or legal guardians can comply with study procedures including follow-up

Exclusion Criteria:

  1. Previously received any meningococcal A, C, W and Y vaccines.
  2. Previous confirmed or suspected disease caused by N. meningitidis or who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection at any time since birth.
  3. Progressive, unstable or uncontrolled clinical conditions.
  4. A history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component, such as latex allergy.
  5. Experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C [100.4°F]) within the previous 3 days.
  6. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  7. Received treatment with systemic administration corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth
  8. Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin) at any time since birth and for the full length of the study.
  9. Any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw.
  10. Any condition which, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
  11. Received or are planning to receive any investigational or non-registered medicinal product from birth and throughout the study.
  12. Received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled blood draw (topical antibiotics are acceptable, including antibiotic eye drops).
  13. Relatives of site research staff working on this study.

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: MenACWY Group
Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who will receive 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly at 2,4,6 ad 12 months of age.
생물학적: MenACWY
Four Intramuscular doses of MenACWY vaccine at 2, 4, 6 and 12 months of age followed by two blood samples at 13 and 24 months of age.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination.
기간: Within 30 minutes of each vaccination
Solicited signs and symptoms occurring within 30 minutes following each vaccination, include solicited local events (e.g. injection site erythema, induration and tenderness -threshold for Erythema and Induration: Type II- None [<10mm], Any[>=10 mm]), solicited systemic events (e.g. change in eating habits, sleepiness, irritability, vomiting, diarrhea, fever[ body temperature >=38°C measured preferably via tympanic route]), and any other solicited event like use of analgesic/antipyretics for treatment or for prophylaxis
Within 30 minutes of each vaccination
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination
기간: From Day 1 to Day 7 after each vaccination
Solicited local AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed local symptoms include injection site erythema, injection site induration and injection site tenderness. Any = incidence of a particular symptom regardless of intensity grade.Threshold for Erythema and Induration: Type II None (<10 mm), Any (>=10 mm)
From Day 1 to Day 7 after each vaccination
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination.
기간: From Day 1 to Day 7 after each vaccination
Solicited systemic AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed systemic symptoms include change in eating habits, sleepiness, irritability, vomiting, diarrhea and fever (body temperature ≥ 38°C (100.4°F)).
From Day 1 to Day 7 after each vaccination
Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal
기간: From Day 1 to Visit 6 (at 24 Months of age)
An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject parent(s)/legal guardian(s)] who has signed the informed consent. All medically attended unsolicited AEs were collected from Day 1 to Visit 6.
From Day 1 to Visit 6 (at 24 Months of age)
Number of Subjects With Serious AEs (SAEs)
기간: From Day 1 to Visit 6 (At 24 months of age)
Subjects reporting SAEs from day 1 to visit 6 (at 24 months of age) were assessed. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
From Day 1 to Visit 6 (At 24 months of age)
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age.
기간: At 24 months of age (Visit 6)
To assess antibody persistence against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.
At 24 months of age (Visit 6)
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age
기간: At 24 months of age (Visit 6)
To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement
At 24 months of age (Visit 6)
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age
기간: At 24 months of age (Visit 6)
To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement
At 24 months of age (Visit 6)

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
기간: At 13 months of age (Visit 5)
To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.
At 13 months of age (Visit 5)
Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
기간: At 13 months of age (Visit 5)
To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.
At 13 months of age (Visit 5)
Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
기간: At 13 months of age (Visit 5)
To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.
At 13 months of age (Visit 5)
hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age
기간: At 24 months of age (Visit 6)
To assess persistence of antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
At 24 months of age (Visit 6)
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age
기간: At 24 months of age (Visit 6)
To assess persistence of antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
At 24 months of age (Visit 6)
hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
기간: At 13 months of age (Visit 5)
To assess antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
At 13 months of age (Visit 5)
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age.
기간: At 13 months of age (Visit 5)
To assess antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
At 13 months of age (Visit 5)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

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)

2015년 7월 13일

기본 완료 (실제)

2017년 12월 28일

연구 완료 (실제)

2017년 12월 28일

연구 등록 날짜

최초 제출

2015년 5월 13일

QC 기준을 충족하는 최초 제출

2015년 5월 15일

처음 게시됨 (추정)

2015년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 6월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 6월 13일

마지막으로 확인됨

2019년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 205336
  • V59_75 (기타 식별자: Novartis)
  • 2014-005392-90 (EudraCT 번호)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

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. .

구독하다