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View Clinical Trial (Medical Research Study)
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A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Viral Shedding of MEDI-559 in Healthy 1 to <12 Month-Old Children - NCT00767416-78229A (Clinical Trial 244967)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy244967.aspx
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| City: |
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San Antonio |
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State:
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TX |
| Zip Code: |
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78229 |
| Conditions: |
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Healthy |
| Purpose: |
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The primary objective of this study is to describe the safety and tolerability of three doses
of MEDI-559 at 10:5 FFU when administered to healthy RSV seronegative children 1 to <12
months.
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| Study summary: |
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The primary objective of this study is to describe the safety and tolerability of three doses
of MEDI-559 at 10:5 FFU when administered to healthy RSV seronegative children 1 to <12
months of age and to healthy infants 1 to <3 months of age regardless of baseline
serostatus. |
| Criteria: |
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Inclusion Criteria:
- Male or female whose age on the day of randomization falls within one of the two age
cohorts: Cohort 1: 5 to <12 months (reached their 5th month birthday but not yet
reached their 1st 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 as determined by ELISA; or
the legal representative is willing to provide access to data documenting that the
subject was screened for another MedImmune trial after written informed consent was
obtained, and that the subject is seronegative to RSV within 21 days prior to
randomization into MI-CP147 as determined by ELISA at MedImmune
- Subject was the product of normal full term pregnancy (defined as 36-42 weeks
gestation)
- Subject is in general good health
- Subject's legal representative is available by telephone throughout the trial period
- Written informed consent and HIPAA authorization (if applicable) obtained from the
subject's legal representative
- Subject's legal representative is able to understand and comply with the requirements
of the protocol as judged by the investigator
- Subject is available to complete the follow-up period, which will be through the end
of RSV season (provisionally defined as 01Apr) or 180 days after the final dose of
study vaccine, whichever is later
- 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 Criteria:
- Any fever (≥ 100.4°F [≥ 38.0°C]), regardless of route within 7 days prior to
randomization; rectal temperature measurement is strongly preferred for accuracy;
temperature measurement by other methods is strongly discouraged
- 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 (see
APPENDIX D)
- Cohort 2 only: history of low birth weight (ie, <2500 grams at birth) or weight ≤ 5th
percentile for age on the day of randomization (see APPENDIX D)
- Any drug therapy (chronic or other) within 7 days prior to randomization or expected
receipt through the protocol-specified blood collection 28 days after each study
vaccine dosing, except that infrequent use of over-the-counter medications for the
symptomatic treatment of common childhood illnesses (eg, pain relievers,
decongestants, or cough suppressants) are permitted according to the judgment of the
investigator
- Any current or expected receipt of immunosuppressive agents including steroids (≥ 2
mg/kg per day of prednisone or its equivalent, or ≥ 20 mg/day if the subject weighs
>10 kg, given daily or on alternate days for ≥ 14 days); children in this category
should not receive study vaccine until immunosuppressive agents including
corticosteroid therapy have been discontinued for ≥ 30 days; the use of topical
steroids is permitted according to the judgment of the investigator
- History of receipt of blood transfusion or expected receipt through 28 days after
final study vaccine dosing
- History of receipt of immunoglobulin products or expected receipt through 28 days
after final study vaccine dosing
- Receipt of any investigational drug within 60 days prior to randomization or expected
receipt through 28 days after final study vaccine dosing
- Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior
to randomization or expected receipt within a 28-day window around any study vaccine
dose
- Receipt of any inactivated (eg, non-live) vaccine or rotavirus vaccine within 14 days
prior to randomization or expected receipt within a 14-day window around any study
vaccine dose
- Known or suspected immunodeficiency, including HIV infection
- Living in the same home or enrolled in the same classroom at day care with infants <24
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
- A household contact who is immunocompromised; the subject should also avoid close
contact with immunocompromised individuals for at least 28 days after each study
vaccine dosing
- A household contact who works in the healthcare field with direct patient care
responsibilities within 28 days after each dose
- A household contact who is a day care provider or preschool teacher for children <24
months of age within 28 days after each dose
- History of allergic reaction to any component of the study vaccine
- 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
- Known or suspected active or chronic hepatitis infection
- History of medical diagnosis of asthma, reactive airway disease, wheezing requiring
medication, bronchoconstriction or treatment with a β2 agonist (eg, albuterol), cystic
fibrosis, chronic lung disease of prematurity (eg, bronchopulmonary dysplasia),
chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory
illness, or mechanical ventilation for respiratory illness (excludes elective
mechanical ventilation during surgery for subjects in Cohort 1)
- Family member or household contact who is an employee of the research center or
otherwise involved with the conduct of the study
- Any condition that, in the opinion of the investigator, might interfere with study
vaccine evaluation |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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September 1, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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