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Completed

NCT Number: NCT00113490

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children

The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.

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Key information

Conditions

Motavizumab Administration for a Second Season for RSV Prophylaxis

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pontificia Universidade Catolica Do Rio Grande, Porto Alegre, Brazil

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About this study

This was a Phase 1/2, randomized, double-blind study in which motavizumab (MEDI-524) or palivizumab was administered to children who previously participated in MI-CP104. Children who received at least 3 doses of motavizumab in MI-CP104 were eligible for enrollment. Subjects were randomized 1:1 to receive motavizumab or palivizumab at 15 mg/kg by IM injection every 30 days for a total of 4-5 injections during the 2004-05 RSV season subsequent to the season in which they were participants of MI-CP104. All subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations, one at 30 days and the other at 90-120 days after the last dose.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104
  • The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday)
  • The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months)
  • Written informed consent obtained from the patient's parent(s) or legal guardian

Exclusion criteria

  • Currently hospitalized
  • Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
  • Evidence of infection with hepatitis A, B, or C virus
  • Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
  • Suspected serious allergic or immune mediated events with prior receipt of MEDI-524
  • Acute illness or progressive clinical disorder
  • Active infection, including acute respiratory syncytial virus (RSV) infection at the time of enrollment
  • Previous reaction to IGIV, blood products, or other foreign proteins
  • Have ever received palivizumab
  • Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam(R)], IVIG), or any investigational agents (except MEDI-524)
  • Currently participating in any investigational study

Treatment and study plan

motavizumab (MEDI-524)

Biological

Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.

Other names: motavizumab, Rezield

palivizumab 15 mg/kg

Biological

Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.

Other names: synagis

Primary outcomes

  1. Number of Subjects Exhibiting Anti-motavizumab Antibodies

    Time frame: Day 0 through 120 days post final dose

    Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.

Secondary outcomes

  1. Number of Subjects Reporting Adverse Events (AEs)

    Time frame: Day 0 through 30 days post final dose

    Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.

  2. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Time frame: Day 0 through 30 days post final dose

    Assessments of SAEs were made by clinical investigators according to the protocol.

  3. Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations

    Time frame: Day 0 through 30 days post final dose

    Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation.

  4. Motavizumab Serum Concentrations at Each Data Collection Visit

    Time frame: Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose

    Mean serum concentration.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 9, 2005
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.