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

NCT00767416 | Completed Phase 1 DMC

• 1 other identifier: MI-CP147
• Study Type: interventional
• Target: 116
• Locations: 2 countries
• Sites: 76

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 to \<24 months of age.

Conditions

Healthy

Keywords

MEDI-559; Respiratory Syncytial Virus; RSV; Pediatric; Vaccine; respiratory syncytial virus, RSV, pediatric, vaccine

Outcome Measures

Primary Outcomes (10)

• Incidence of solicited symptoms after Dose 1

  Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis

  Through Day 28 after each dose

• Incidence of solicited symptoms after Dose 2

  Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis

  Through Day 28 after each dose

• Incidence of solicited symptoms after Dose 3

  Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis

  Through Day 28 after each dose

• Incidence of adverse events (AEs) after Dose 1

  As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  Through Day 28 after each dose

• Incidence of AEs after Dose 2

  As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  Through Day 28 after each dose

• Incidence of AEs after Dose 3

  As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  Through Day 28 after each dose

• Incidence of medically-attended lower respiratory illnesses (MA-LRIs) after Dose 1

  An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea

  Through Day 28 after each dose

• Incidence of MA-LRIs after Dose 2

  An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea

  Through Day 28 after each dose

• Incidence of MA-LRIs after Dose 3

  An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea

  Through Day 28 after each dose

• Incidence of SAEs

  An SAE is any adverse event that results in any of the following outcomes: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly/birth defect (in the offspring of a subject); an important medical event that may not result in death, threaten life or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, it may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.

  Administration of Dose 1 (Day 0) through Day 28 post final dose

Secondary Outcomes (13)

• Incidence of MEDI-559 shedding

  Day 7-10 after Dose 1, 2, and 3

• Incidence of MEDI-559 shedding

  Day 12-18 after Dose 1, 2, and 3

• Incidence of MEDI-559 shedding

  Day 28-34 post Dose 1, 2, and 3

• Post-vaccination seroresponse against RSV

  Day 28 post final dose

• Phenotypic stability of recovered vaccine-type virus

  Day 7-10 post any dose

Study Arms (2)

Cohort 1 MEDI-559

EXPERIMENTAL

MEDI-559

Biological: MEDI-559

Cohort 1 Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

MEDI-559 BIOLOGICAL

Cohort 1 (5 to \<24 months): N=80 MEDI-559 at 10\^5 FFU at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains 10\^5 FFU MEDI-559 in a sucrose phosphate glutamate buffer.

Cohort 1 MEDI-559

Placebo OTHER

Cohort 1 (5 to \< 24 months); N = 80 placebo at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains sucrose phosphate buffer.

Cohort 1 Placebo

Eligibility Criteria

• Age: 1 Month - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (76)

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Greenville, Alabama, 36037, United States

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Huntsville, Alabama, 35802, United States

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Mobile, Alabama, 36608, United States

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Conway, Arkansas, 72034, United States

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Little Rock, Arkansas, 72202, United States

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Little Rock, Arkansas, 72205, United States

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Anaheim, California, 92804, United States

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Cypress, California, 90630, United States

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Downey, California, 90241, United States

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Huntington Beach, California, 92647, United States

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Lakewood, California, 90712, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90015, United States

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Los Angeles, California, 90024, United States

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Paramount, California, 90723, United States

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San Diego, California, 92103, United States

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Santa Ana, California, 92705, United States

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Thornton, Colorado, 80223, United States

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Hartford, Connecticut, 06106, United States

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Washington D.C., District of Columbia, 20058, United States

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Miami, Florida, 33142, United States

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Miami, Florida, 33155, United States

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Orange City, Florida, 32763, United States

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Tampa, Florida, 33606, United States

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Dalton, Georgia, 30721, United States

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Chicago, Illinois, 60614, United States

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Fishers, Indiana, 46037, United States

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New Albany, Indiana, 47150, United States

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South Bend, Indiana, 46601, United States

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Ames, Iowa, 50010, United States

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Bardstown, Kentucky, 40004, United States

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Lexington, Kentucky, 40503, United States

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Lexington, Kentucky, 40509, United States

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Louisville, Kentucky, 40202, United States

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Louisville, Kentucky, 40207, United States

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Paducah, Kentucky, 42003, United States

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Metarie, Louisiana, 70006, United States

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Fredrick, Maryland, 21215, United States

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Boston, Massachusetts, 02111, United States

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Fall River, Massachusetts, 02724, United States

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Bridgeton, Missouri, 63044, United States

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Kansas City, Missouri, 64132, United States

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Omaha, Nebraska, 68131, United States

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Omaha, Nebraska, 68134, United States

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Brooklyn, New York, 11219, United States

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Endwell, New York, 13760, United States

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Stony Brook, New York, 11794, United States

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Syracuse, New York, 13210, United States

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Cleveland, Ohio, 44109, United States

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Cleveland, Ohio, 44121, United States

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Huber Heights, Ohio, 45424, United States

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Norman, Oklahoma, 73071, United States

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Tulsa, Oklahoma, 74127, United States

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Warwick, Rhode Island, 02886, United States

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Spartanburg, South Carolina, 29303, United States

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Franklin, Tennessee, 37067, United States

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Jackson, Tennessee, 38305, United States

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Johnson City, Tennessee, 37604, United States

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Kingsport, Tennessee, 37660, United States

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Corpus Christi, Texas, 78414, United States

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Houston, Texas, 77036, United States

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Houston, Texas, 77055, United States

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San Angelo, Texas, 76904, United States

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San Antonio, Texas, 78205, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78258, United States

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Tomball, Texas, 77375, United States

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Layton, Utah, 84041, United States

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St. George, Utah, 84790, United States

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Syracuse, Utah, 84075, United States

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Charlottesville, Virginia, 22902, United States

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Colonial Heights, Virginia, 23834, United States

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Midlothian, Virginia, 23113, United States

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Richmond, Virginia, 23219, United States

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Walla Walla, Washington, 99362, United States

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Caguas, 00726, Puerto Rico

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Related Publications (1)

• Malkin E, Yogev R, Abughali N, Sliman J, Wang CK, Zuo F, Yang CF, Eickhoff M, Esser MT, Tang RS, Dubovsky F. Safety and immunogenicity of a live attenuated RSV vaccine in healthy RSV-seronegative children 5 to 24 months of age. PLoS One. 2013 Oct 29;8(10):e77104. doi: 10.1371/journal.pone.0077104. eCollection 2013.

  PMID: 24204744 DERIVED

Related Links

• MEDI-559\_CP-147\_Protocol\_Redacted\_13Nov13

MeSH Terms

Interventions

MEDI-559

Study Officials

• Joseph Sliman, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 7, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

US (75); PR (1)