Study Interchangeability Hep-B Vaccine Administered at Birth Dose
Randomized, Double-Blind, Interchangeability Study of In-House Recombinant Hepatitis B (Bio Farma) at Birth Dose Followed by RRegistered DTwP-HepB-IPV-Hib (HEXASIIL) Vaccine in Indonesian Infants
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
연구 개요
상태
상세 설명
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
Approximately 270 newborns will be enrolled in this trial, divided into 2 arms, with the ratio 1:1. The subject will receive one dose of In-House Recombinant Hepatitis B at birth or registered monovalent Hepatitis B as a control then followed by registered DTwP-HepB-IPVHib (HEXASIIL) vaccine
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Rini Mulia Sari, MD
- 전화번호: 14102 +622033755
- 이메일: rini.mulia@biofarma.co.id
연구 연락처 백업
- 이름: Mita Puspita, MD
- 전화번호: 5045 +622033755
- 이메일: mita.puspita@biofarma.co.id
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy, full term, newborn infants.
- Infant born between 37-42 weeks of pregnancy.
- Infant weigh between 2500 - 4000 gram at birth.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.
Exclusion Criteria:
- Infants concomitantly enrolled or scheduled to be enrolled in another trial.
- Infants evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C on Day 0).
- Infants suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis.
- Infants received or plans to receive any treatment likely to alter the immune response intravenously (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
- Infants received other vaccinations with the exception of BCG, poliomyelitis, rotavirus, and PCV.
- Infants with HbsAg and HIV positive (from cord blood)
- Mother suspected of immunodeficiency disease based on anamnesis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Hep B vaccine in-house
0,5 ml of In-house Recombinant Hepatitis B (Bio Farma) vaccine injected at birth |
0,5 ml In-House Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh |
|
활성 비교기: Registered Hep B vaccine
0,5 ml of Regstered Hepatitis B (Bio Farma) vaccine injected at birth |
0,5 ml Registered Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Protectivity of primary series In-House Recombinant Hepatitis B vaccine
기간: 28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
Percentage of subjects with anti HBsAg > 10mIU/ml after the completion of the primary series of recombinant hepatitis B and Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine for each group |
28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Immunogenicity of birth dose In-House Recombinant Hepatitis B vaccine
기간: 28 days after administration of Hep B birth dose vaccine
|
GMT and percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive after birth dose Hep B vaccine |
28 days after administration of Hep B birth dose vaccine
|
|
Immunogenicity of In-House recombinant Hepatitis B vaccine after the completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
기간: 28 days after the third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
GMT and percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive after completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine |
28 days after the third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
|
Safety of In-House Recombinant Hepatitis B vaccine
기간: 30 minutes, 7 days, 28 days after each dose
|
Percentage of subjects with solicited and unsolicited adverse events after each dose |
30 minutes, 7 days, 28 days after each dose
|
|
Serious Adverse Events
기간: 28 days after third dose of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine administration
|
Percentage of infants with at least one serious adverse events |
28 days after third dose of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine administration
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Rodman Tarigan Girsang, MD, Faculty of Medicine, Padjadjaran University, Bandung
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HepB0226
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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