A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety of MEDI-559 in Healthy 1 to <24 Month-Old Children

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Healthy

In brief

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 to \<24 months of age.

Key facts

Study ID: NCT00767416
Run by: MedImmune LLC
People needed: 116
Starts: 2008-10-01
Expected to finish: 2011-12-01
Last updated by the study team: 2016-07-20

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — Huntsville, Alabama, United States
Research Site — Mobile, Alabama, United States
Research Site — Conway, Arkansas, United States
Research Site — Little Rock, Arkansas, United States
Research Site — Little Rock, Arkansas, United States
Research Site — Anaheim, California, United States
Research Site — Cypress, California, United States
Research Site — Downey, California, United States
Research Site — Huntington Beach, California, United States
Research Site — Lakewood, California, United States
Research Site — Long Beach, California, United States
Research Site — Los Angeles, California, United States
Research Site — Los Angeles, California, United States
Research Site — Paramount, California, United States
Research Site — San Diego, California, United States
Research Site — Santa Ana, California, United States
Research Site — Thornton, Colorado, United States
Research Site — Hartford, Connecticut, United States
Research Site — Washington D.C., District of Columbia, United States
Research Site — Miami, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Orange City, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Dalton, Georgia, United States
Research Site — Greenville, Alabama, United States

Full record on ClinicalTrials.gov

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