EUCTR2015-000382-31-AT进行中（未招募）1 期
A Phase 3, Open-label, Multicenter Study to Evaluate Long-term Immunogenicity and Boostability of Immune Responses in Adults who Received Different Primary Vaccination Regimens of Pre-exposure Prophylaxis with Purified Chick-Embryo Cell Rabies Vaccine Administered Concomitantly or Separately from a Japanese Encephalitis Vaccine. - RABIES-018 BST:017 (V49_23E1)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 578
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
- •1.All individuals who were randomized to Conventional Rabies and JE vaccination or to Accelerated Rabies and JE vac-cination or to Conventional Rabies groups during the par-ent study, who received the full PrEP regimen and com-pleted the trial following V49_23 study protocol.
- •2.Individuals who have voluntarily given written informed con-sent after the nature of the study has been explained ac-cording to local regulatory requirements, prior to study en-try.
- •3.Individuals who can comply with study procedures
- •Females of non-childbearing potential
- •Females of childbearing potential who are using an effective birth control method which they intend to use for at least 6 months after the booster vaccination. This criterion is applicable only for those subjects who receive a booster dose.
- •Prior to receipt of booster vaccination during Ad hoc Clinic Visit, subjects must be evaluated to confirm that they are eligible. If subjects do not meet any of the original inclusion criteria listed above, they should not receive booster dose of rabies vaccine.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 578
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Prior to extension study entry, each subject must not have:
- •1. Completed the parent study V49_23 without receiving the full 3 rabies vaccine doses following the assigned pre-exposure prophylaxis regimen.
- •2. History of exposure to suspected or confirmed rabid animal.
- •3. Receipt of rabies immunoglobulins, rabies post exposure prophylaxis following completion of V49_23 study.
- •4. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
- •5. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- •6. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent or planning to receive them during the participation to the study.
- •7. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent or planning to receive them during the participation to the study.
- •8. Received immunoglobulins or any blood products within 180 days prior to informed consent or planning to receive them during the participation to the study.
- •9. Study personnel as well as their immediate family or household member.
- •10. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
- •Prior to Scheduled Visit, each subject must not have:
- •1. History of exposure to suspected or confirmed rabid animal.
- •2. Receipt of rabies immunoglobulins, non-study rabies vaccine following completion of V49_23 study.
- •3. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
- •4. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- •5. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent or planning to receive them during the participation to the study.
- •6. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent or planning to receive them during the participation to the study.
- •7. Received immunoglobulins or any blood products within 180 days prior to informed consent or planning to receive them during the participation to the study.
- •8. Study personnel as well as their immediate family or household member.
- •9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
- •Prior to booster vaccination, each subject eligible for booster vaccination (i.e., subjects with RVNA concentrations <0.5 IU/mL at the first visit of this extension study [Day 1, Year 3] or at the following year visits [Year 4 to Year 9]) should be in good health status and must not have none of the following:
- •1. Progressive, unstable or uncontrolled clinical conditions.
- •2. Abnormal function of the immune system resulting from:
- •a. Clinical conditions.
- •b. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to the Ad hoc visit or receipt or planning to receive them during the participation to the study.
- •c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to the Ad hoc visit or receipt or planning to receive them during t
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