Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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
This study is currently recruiting participants.
Verified by MedImmune LLC, October 2008
Sponsored by: MedImmune LLC
Information provided by: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00767416
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: MEDI-559
Other: Placebo
Phase I
Phase II

Drug Information available for: Sucrose
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-559, a Live Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus in Healthy 1 to <12 Month-Old Children

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • To describe the safety and tolerability of three (3) doses of Medi-559 at 10:5 FFU in seronegative children 5 to <12 mos. of age and in infants 1 to <3 mos. of age regardless of baseline serostability. [ Time Frame: Through day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence and magnitude of MEDI-559 shedding [ Time Frame: Days 7, 12, and 28 after each dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: October 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
MEDI-559
Biological: MEDI-559
Cohort 1 (5 to <12 months): N=80 MEDI-559 at 105 FFU at 0, 2, and 4 months N=80 Placebo at 0, 2, and 4 months
2: Experimental
MEDI-559
Biological: MEDI-559
Cohort 2 (1 to <3 months): N=80 MEDI-559 at 105 FFU at 0, 2, and 4 months N=80 Placebo at 0, 2, and 4 months
Placebo: Placebo Comparator
Placebo
Other: Placebo
frozen preparation filled into 0.5 ml; each 0.2 ml dose contains sucrose phosphate buffer.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Months to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767416

Contacts
Contact: Michele Jordan 301-398-4167
Contact: Mark Eickhoff 301-398-5038

Locations
United States, Arkansas
Arkansas Pediatric Research Division Recruiting
Bentonville, Arkansas, United States, 72712
Contact: Elise Campion     479-273-5437     elisecampion.chirp@yahoo.com    
Principal Investigator: Bryan Harvey, M.D.            
United States, Kentucky
IGLU Recruiting
Lexington, Kentucky, United States, 40503
Contact: Carol Rush     859-277-6516     simonrn@iglou.com    
Principal Investigator: Simon, M.D.            
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Raburn Mallory, M.D. MedImmune LLC
  More Information

Responsible Party: MedImmune LLC ( Raburn Mallory, MD )
Study ID Numbers: MI-CP147
Study First Received: October 3, 2008
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00767416  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Healthy

ClinicalTrials.gov processed this record on January 16, 2009