Status:
COMPLETED
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety of MEDI-559 in Healthy 1 to <24 Month-Old Children
Lead Sponsor:
MedImmune LLC
Conditions:
Healthy
Eligibility:
All Genders
1-23 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10\^5 FFU when administered to healthy RSV seronegative children 1 t...
Detailed Description
This is a randomized, double-blind, placebo-controlled, multi-dose, Phase 1/2a multi-center trial to evaluate the safety, tolerability, viral shedding, immunogenicity, and genotypic and phenotypic sta...
Eligibility Criteria
Inclusion
- Male or female whose age on the day of randomization falls within one of the two age cohorts: Cohort 1: 5 to \<24 months (reached their 5th month birthday but not yet reached their 2nd year birthday); Cohort 2: 1 to \< 3 months (\>28 days of age and not yet reached their 3rd month birthday)
- Cohort 1 only: Subject is seronegative to RSV at screening
- Subject was the product of normal full term pregnancy (defined as 36-42 weeks gestation)
- Subject is in general good health
- Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative
- Subject's legal representative is willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol
Exclusion
- Any fever (≥ 100.4°F \[≥ 38.0°C\]), regardless of route within 7 days prior to randomization
- Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
- Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine
- Cohort 1 only: weight ≤ 5th percentile for age on the day of randomization
- Cohort 2 only: history of low birth weight (ie, \<2500 grams at birth) or weight ≤ 5th percentile for age on the day of randomization
- Living in the same home or enrolled in the same classroom at day care with infants \<6 months of age within 28 days after each dose (only one child per household may be enrolled into the study)
- Contact with pregnant caregiver within 28 days after each dose
- Living in a household with someone who is immunocompromised within 28 days after each dose; the subject should also avoid close contact with immunocompromised individuals for at least 28 days after each study vaccine dosing
- Living in a household with someone who works in the healthcare field and who has direct patient care responsibilities within 28 days after each dose
- Living in a household with someone who is a day care provider or preschool teacher for children \<6 months of age within 28 days after each dose
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00767416
Start Date
October 1 2008
End Date
December 1 2011
Last Update
July 20 2016
Active Locations (76)
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1
Research Site
Greenville, Alabama, United States, 36037
2
Research Site
Huntsville, Alabama, United States, 35802
3
Research Site
Mobile, Alabama, United States, 36608
4
Research Site
Conway, Arkansas, United States, 72034