Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns
Phase III Immunogenicity, Safety, Poliovirus Excretion and Acceptance of Vaccination OPV (Vero Cells) in Newborns Mexicans
Polio is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis in a matter of hours. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing muscles become immobilized. There is no cure for polio, it can only be prevented. Polio vaccine, given multiple times, can protect a child for life.
Compare in newborns the immunogenicity and safety of the vaccine OPV produced by Birmex compared with the vaccine OPV produced by Sanofi Pasteur, both produced in Vero cells.
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Estado de México
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Valle de Chalco, Estado de México, 멕시코, 56613
- 모병
- Hospital General de Chalco Dr. Fernando Quiroz Gutierrez
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수석 연구원:
- Monserrat Ávila-Flores, Pediatrics
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Newborns babies
- Weight ≥ 2.5 kg
- Have not received any doses of Polio Vaccine
- Whose parents or guardians reside in the work area
- Whose parent or guardian accept to sign written informed consent (by the other, father or guardian).
Exclusion Criteria:
- Born of a high-risk pregnancy.
- Weight ≤ 2.5 kg
- Presence of fever, diarrhea, known immunosuppression, respiratory infections.
- Treatment with immunosuppressants.
- Having neurological diseases.
- Require or received surgery in oropharynx.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Trivalent OPV Birmex
Newborns receive OPV vaccine produced in Vero cells by Birmex one dose of vaccine.
A second dose four weeks after the first application.
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Newborns who receive OPV vaccine produced in Vero cells by Birmex one dose of vaccine immediately after random allocation (at birth).
A second dose is given four weeks after the first application.
다른 이름들:
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활성 비교기: Trivalent OPV Sanofi Pasteur
Newborns who receive OPV vaccine produced in Vero cells by Sanofi Pasteur one dose of vaccine.
A second dose four weeks after the first application.
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Newborns who receive OPV vaccine produced in Vero cells by Sanofi Pasteur one dose of vaccine immediately after random allocation (at birth).
A second dose is given four weeks after the first application.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change seroconversion after one dose of trivalent vaccine OPV
기간: after the first dose is taken blood samples (baseline, 30 and 60 days)
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after the first dose is taken blood samples (baseline, 30 and 60 days)
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Evaluate the adverse events in newborns babies
기간: inmediately after treatment and during 60 days
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inmediately after treatment and during 60 days
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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Poliovirus Excretion
기간: Evaluate viral excretion rate, basal 7, 14, 21 and 28 days after vaccination of two vaccines against polio OPV in newborns Mexicans
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Evaluate viral excretion rate, basal 7, 14, 21 and 28 days after vaccination of two vaccines against polio OPV in newborns Mexicans
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mauricio Rodríguez Álvarez, PhD, Laboratorios de Biológicos y Reactivos de México S.A de C.V
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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