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.
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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-
Estado de México
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Valle de Chalco、Estado de México、メキシコ、56613
- 募集
- Hospital General de Chalco Dr. Fernando Quiroz Gutierrez
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主任研究者：
- Monserrat Ávila-Flores, Pediatrics
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
他の名前：
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アクティブコンパレータ：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.
|
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Change seroconversion after one dose of trivalent vaccine OPV
時間枠：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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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Evaluate the adverse events in newborns babies
時間枠：inmediately after treatment and during 60 days
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inmediately after treatment and during 60 days
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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Poliovirus Excretion
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Mauricio Rodríguez Álvarez, PhD、Laboratorios de Biológicos y Reactivos de México S.A de C.V
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。