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 Infants

• Conditions: MEDI-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 infestations; MedDRA version: 14.1Level: PTClassification code 10061907Term: Parainfluenzae virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2008-002651-24-FI
• Lead Sponsor: MedImmune, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-01
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified