EUCTR2008-002651-24-FI进行中（未招募）不适用
A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month Old Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 720
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
- •Subjects must meet all of the following criteria:
- •1. Male or female whose age on the day of randomization falls within one of the two age groups: Cohorts 1 and 2: 6 to < 24 months (=6 months of age and not yet reached their 2nd year birthday);
- •Cohorts 3, 4, and 5: 2 months +/- 4 weeks
- •2. Cohorts 1 and 2 only: Subject is seronegative to both RSV and hPIV3 at screening
- •3. Subject whose gestational age was = 36 weeks
- •4. Subject is in general good health with normal growth (ie, body weight > 3rd percentile per WHO simplified weight-per-age field tables)
- •5. Subject’s legal representative is available by telephone
- •6. Written informed consent obtained from the subject’s legal representative
- •7. Subject’s legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator
- •8. Subject is available to complete the follow-up period, which will be 1 year after receipt of the first dose of study vaccine
- •9. Subject’s legal representative must be willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 720
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects must have none of the following:
- •1. Any fever (greater than or equal to 100.4°F [greater than or equal to 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization
- •2. Moderate or severe nasal congestion that, in the investigator’s opinion, could interfere with intranasal delivery of study vaccine
- •3. Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
- •4. Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through 28 days after each study vaccine dosing, except that infrequent use of over-the-counter medications for the systemic treatment of common childhood symptoms (eg, pain relievers, decongestants or cough suppressants) are permitted according to the judgment of the investigator
- •5. Any current or expected receipt of immunosuppressive agents including steroids (greater than or equal to 2 mg/kg per day of prednisone or its equivalent, or greater than or equal to 20 mg/day if the subject weighs > 10 kg, given daily or on alternate days for greater than or equal to 14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for greater than or equal to 30 days; the use of topical steroids is permitted according to the judgment of the investigator
- •6. History of receipt of blood transfusion or expected receipt through the protocol-specified blood collection at 28 days after final study dosing
- •7. History of receipt of immunoglobulin products or expected receipt through the protocol-specified blood collection at 28 days after final study dosing
- •8. Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after final study dosing
- •9. Receipt of any live virus vaccine (excluding oral polio vaccine and rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any study vaccine dose
- •10. Receipt of any inactivated (ie, non-live) vaccine or oral polio vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose
- •11. Known or suspected immunodeficiency, including HIV infection
- •12. Expected to be living in the same home or enrolled in the same classroom at day care with infants < 6 months within 28 days after each dose
- •13. Living in a household with another child who is concurrently enrolled in a study of a live viral vaccine (including this study)
- •14. Expected contact with a pregnant caregiver within 28 days after each dose
- •15. A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 28 days after any study vaccine dose
- •16. Expected household contact within 28 days after each dose with a health care provider for immunocompromised patients or who is a day care provider for infants under the age of 6 months
- •17. History of allergic reaction to any component of the study vaccine
- •18. Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject
- •19. Known or suspected active or chronic hepatitis infection
- •20. History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonar
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