EUCTR2008-002651-24-GB进行中（未招募）1 期
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
- 1 期
- 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
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:
- •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 tha
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A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month Old InfantsMEDI-534 is being investigated for the prevention of respiratory syncytial virus (RSV) and human parainfluenza virus type 3 (hPIV3) infections and disease in young children and infants.MedDRA version: 14.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: PTClassification code 10061907Term: Parainfluenzae virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2008-002651-24-FIMedImmune, LLC720
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