A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month Old Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00686075
First received: May 23, 2008
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

To describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to < 24 months of age and in infants 2 months of age (infants and children 1 to < 24 months.


Condition Intervention Phase
Respiratory Syncytial Virus (RSV)
Parainfluenza Virus Type 3 (PIV3)
Biological: MEDI-534
Biological: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 719
Study Start Date: July 2008
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI-534
Biological: MEDI-534
Cohort 1 (6 to < 24 mos): N = 80 MEDI-534 at 10:5 TCID:50 at 0, 2, and 4 months
Experimental: 2
MEDI-534
Biological: MEDI-534
Cohort 2 (6 to < 24 mos): N = 80 MEDI-534 at 10:6 TCID:50 at 0, 2, and 4 months
Experimental: 3
MEDI-534
Biological: MEDI-534
Cohort 3 (2 mos.): N = 40 MEDI-534 at 10:4 TCID:50 at 0, 2, and 4 months
Experimental: 4
MEDI-534
Biological: MEDI-534
Cohort 4 (2 mos.): N = 80 MEDI-534 at 10:5 TCID:50 at 0, 2, and 4 months
Experimental: 5
MEDI-534
Biological: MEDI-534
Cohort 5 (2 mos.): N = 80 MEDI-534 at 10:6 TCID:50 at 0, 2, and 4 months
Placebo Comparator: 6
Placebo
Biological: Placebo
N = 40 Placebo at 0, 2, and 4 months (for Cohort 3); N = 80 Placebo at 0, 2, and 4 months (for Cohorts 1,2,4 & 5)

Detailed Description:

The primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 at 10:5 or 10:6 TCID:50 in RSV and hPIV3 seronegative children 6 to < 24 months of age and at dosages of 10:4, 10:5 or 10:6 TCID:50 in unscreened infants 2 months of age.

  Eligibility

Ages Eligible for Study:   2 Months to 24 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 groups:

    • 1 to < 24 months (> 6 months of age and not yet reached their 2nd year birthday), Cohorts 1 and 2;
    • 2 months (± 4 weeks), Cohorts 3, 4, and 5
  • Cohorts 1 and 2 only: Subject is seronegative to both RSV and hPIV3 at screening
  • Subject whose gestational age was ≥ 36 weeks
  • Subject is in general good health with normal growth (ie, body weight > 3rd percentile per WHO simplified weight-per-age field tables
  • 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 1-year after receipt of the first dose of study vaccine
  • 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 (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization
  • Moderate or severe nasal congestion that in the investigator's opinion could interfere with intranasal delivery of study vaccine
  • Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
  • 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 systemic treatment of common childhood symptoms (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 the protocol-specified blood collection at 28 days after final study dosing
  • History of receipt of immunoglobulin products or expected receipt through the protocol-specified blood collection at 28 days after final study dosing
  • Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after final study dosing
  • Receipt of any live virus vaccine (excluding oral polio vaccine and 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 (ie, non-live) vaccine or oral polio 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
  • Expected to be living in the same home or enrolled in the same classroom at day care with infants < 6 months within 28 days after each dose
  • Living in a household with another child who is concurrently enrolled in a study of a live viral vaccine (including this study)
  • Expected contact with a 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 any study vaccine dose
  • Expected household contact within 28 days after each dose with a health care provider for 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 for respiratory illness (excludes elective mechanical ventilation during surgery for subjects in Cohorts 1 and 2)
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686075

  Show 88 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Elissa Malkin, D.O. MedImmune LLC
  More Information

Additional Information:
No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00686075     History of Changes
Other Study ID Numbers: MI-CP178
Study First Received: May 23, 2008
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Paramyxoviridae Infections
Virus Diseases
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on August 21, 2014