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Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age
This study has been completed.

First Received on June 26, 2007.   Last Updated on October 20, 2011   History of Changes
Sponsor: MedImmune LLC
Information provided by: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00493285
  Purpose

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 RSV and PIV3 disease in young infants.


Condition Intervention Phase
Respirovirus Infections
Respiratory Syncytial Virus Infections
Parainfluenza Virus 3, Human
Biological: MEDI-534
Phase I

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV), in Healthy Children 6 to <24 Months of Age

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 1-Incidence of solicited symptoms from administration of study vaccine through 28 days following each dose. [ Time Frame: Through study day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1-Incidence and magnitude of vaccine-like viral shedding of MEDI-534. [ Time Frame: At study days 7, 12, and 28 after each dose for each treatment group ] [ Designated as safety issue: No ]

Estimated Enrollment: 49
Study Start Date: May 2007
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
MEDI-534 at 10:4 TCID50 at 0, 2, and 4 months (Nasal spray)
Biological: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 to 4, 10 to 5, or 10 to 6 TCID50
Active Comparator: 2
MEDI-534 at 10:5 TCID50 at 0, 2, and 4 months (Nasal Spray)
Biological: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 to 4, 10 to 5 or 10 to 6 TCID50.
Active Comparator: 3
MEDI-534 at 10:6 TCID50 at 0, 2, and 4 months (Nasal Spray)
Biological: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 to 4, 10 to 5 or 10 to 6 TCID50.

Detailed Description:

The primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 at 10 to 4, 10 to 5, or 10 to 6 TCID50 when administered to RSV and PIV3 seronegative children 6 to <24 months of age.

  Eligibility

Ages Eligible for Study:   6 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation
  • 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: NCT00493285

  Show 30 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Elissa Malkin, D.O. MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Elissa Malkin, D.O., MedImmune LLC
ClinicalTrials.gov Identifier: NCT00493285     History of Changes
Other Study ID Numbers: MI-CP149
Study First Received: June 26, 2007
Last Updated: October 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Lower Respiratory Tract Illness
RSV and PIV3 infection

Additional relevant MeSH terms:
Paramyxoviridae Infections
Respirovirus Infections
Respiratory Syncytial Virus Infections
Virus Diseases
Mononegavirales Infections
RNA Virus Infections
Pneumovirus Infections

ClinicalTrials.gov processed this record on February 12, 2012