Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age

NCT00493285 | Completed Phase 1 Results DMC

• 1 other identifier: MI-CP149
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 30

Brief Summary

The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.

Conditions

Respiratory Viral Infections; Respiratory Syncytial Virus Infections; Parainfluenza Virus 3, Human

Keywords

Lower Respiratory Tract Illness; RSV and PIV3 infection

Outcome Measures

Primary Outcomes (9)

• Number of Participants With Solicited Adverse Events (SEs) After Dose 1

  The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.

  Days 0-28 after Dose 1 (Dose 1 was on Day 0)

• Number of Participants With SEs After Dose 2

  The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.

  Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)

• Number of Participants With SEs After Dose 3

  The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.

  Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

• Number of Participants With Adverse Events (AEs) After Dose 1

  Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.

  Days 0-28 after Dose 1 (Dose 1 was on Day 0)

• Number of Participants With AEs After Dose 2

  Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.

  Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)

• Number of Participants With AEs After Dose 3

  Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.

  Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

• Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs)

  An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea.

  Days 0 to 180 days after final dose or the end of the RSV season, whichever was later

• Number of Participants With Serious Adverse Events (SAEs)

  Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes.

  Days 0-28 after any dose

• Number of Participants With Significant New Medical Conditions (SNMCs)

  A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.

  Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later

Secondary Outcomes (27)

• Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation

  Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose.

• Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1

  Days 7-10 after Dose 1 (Dose 1 was on Day 0)

• Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1

  Days 12-18 after Dose 1 (Dose 1 was on Day 0)

• Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1

  Days 28-34 after Dose 1 (Dose 1 was on Day 0)

• Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1

  Days 0-34 after Dose 1 (Dose 1 was on Day 0)

Study Arms (3)

1

ACTIVE COMPARATOR

MEDI-534 at 10\^4 TCID50 at 0, 2, and 4 months (Nasal spray)

Biological: MEDI-534

2

ACTIVE COMPARATOR

MEDI-534 at 10\^5 TCID50 at 0, 2, and 4 months (Nasal Spray)

Biological: MEDI-534

3

ACTIVE COMPARATOR

MEDI-534 at 10\^6 TCID50 at 0, 2, and 4 months (Nasal Spray)

Biological: MEDI-534

Interventions

MEDI-534 BIOLOGICAL

Multiple doses of MEDI-534 or Placebo at 10\^4 TCID50

1

Eligibility Criteria

• Age: 6 Months - 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 is 6 to \<24 months (reached 6th month birthday and not yet reached 2nd year birthday)
• Subject is seronegative to both RSV and PIV3 at screening
• Subject was the product of normal full term pregnancy (defined as \>36 weeks gestation)
• Subject is in general good health
• Subject's legal representative is available by telephone
• 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 01/Apr for the United States) or 180 days after the final dose of study vaccine, whichever is later
• Subject's legal representative must be 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 (equal to or greater than 100.4°F \[equal to or greater than 38.0°C\], regardless of route) or lower respiratory illness (Section 4.1.2) within 7 days prior to randomization
• Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine
• 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 such as pain relievers 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 equal to or greater than 20 mg/day if the subject weighs \>10 kg, given daily or on alternate days for equal to or greater than 14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for equal to or greater than 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 30 days following final study vaccine dosing
• History of receipt of immunoglobulin products or expected receipt through 30 days after study vaccine dosing
• Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 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 (i.e., 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
• Living in the same home or enrolled in the same classroom at day care with infants \<24 months of age (only one child per household may be enrolled into the study)
• Contact with pregnant caregiver
• A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after any study vaccine dose
• A household contact who is a health care provider in contact with immunocompromised patients or who is a day care provider for infants under the age of 6 months
• History of allergic reaction to any component of the study vaccine

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (30)

Arkansas Pediatric Research Division

Conway, Arkansas, 72033, United States

Location

Arkansas Pediatric Clinic

Little Rock, Arkansas, 72205, United States

Location

THe Children's Hospital

Aurora, Colorado, 80045, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Pediatric Partners

Palm Beach Gardens, Florida, 33410, United States

Location

North Georgia Clinical Research Center

Dalton, Georgia, 30721, United States

Location

University Consultants in Allergy and Immunology

Chicago, Illinois, 60612, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 61614, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Tufts-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Craig A. Spiegel, MD

Bridgeton, Missouri, 63044, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Withrop University Hospital

Mineola, New York, 11501, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University Hospitals case Medical Center

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

St. Vincent Mercy Medical Center Mercy Children's Hospital

Toledo, Ohio, 43608, United States

Location

Primary Physicians Research, Inc.

Pittsburgh, Pennsylvania, 15241, United States

Location

Sanford Children's Specialty Clinic

Sioux Falls, South Dakota, 57117, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Health Science Center of Houston Medical School

Houston, Texas, 77030, United States

Location

Bear Care Pediatrics

Ogden, Utah, 84405, United States

Location

Copperview Medical Center

South Jordan, Utah, 84095, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Advanced Pediatrics

Vienna, Virginia, 22180, United States

Location

Rockwood Clinic Research Center

Spokane, Washington, 99202, United States

Location

Marshall University Joan C. Edwards School of Medicine

Huntington, West Virginia, 25701, United States

Location

West Virginia University Health Science Center

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• Bernstein DI, Malkin E, Abughali N, Falloon J, Yi T, Dubovsky F; MI-CP149 Investigators. Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine in seronegative children. Pediatr Infect Dis J. 2012 Feb;31(2):109-14. doi: 10.1097/INF.0b013e31823386f1.

  PMID: 21926667 RESULT

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Elissa Malkin, DO, MPH
• Organization: MedImmune, LLC

malkine@medimmune.com

301-398-0000

Study Officials

• Elissa Malkin, D.O.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 28, 2007
• Study Start: July 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: April 1, 2010
• Last Updated: July 19, 2012
• Results First Posted: April 9, 2012

Record last verified: 2012-07

Locations

US (30)