Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
Condition: Respiratory Syncytial Virus Infections; Chronic Lung Disease and <= 24 Months of Age or; Premature With Gestational Age <=35 Weeks and <=6 Months of Age
MeSH terms: Respiratory Syncytial Virus Infections; Lung Diseases
Intervention: Motavizumab, palivizumab; Palivizumab, motavizumab; Motavizumab
Intervention description: Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.; Palivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine.; Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.
Intervention MeSH terms: Palivizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: All
Maximum age: 24 Months
Healthy volunteers: No
Keywords: Respiratory Syncytial Virus; Premature and under 6 mos. of age; Chronic Lung Disease over 6 mos. of age; palivizumab; motavizumab; RSV

Summary:

      This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and
      palivizumab were administered sequentially to high-risk children during the same respiratory
      syncytial virus (RSV) season. A control group was administered only motavizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The child must have been born at less than or equal to 35 weeks gestation and be less
             than or equal to 6 months of age at the time of entry into the study (child must be
             entered on or before his/her 6-month birthday); or the child must be less than or
             equal to 24 months of age at the time of entry into the study (child must be entered
             on or before his/her 24-month birthday) and diagnosed with chronic lung disease (CLD)
             of prematurity with stable or decreasing doses of diuretics, steroids, or
             bronchodilators, or treatment with supplemental oxygen, within the previous 6 months.

          -  The child must be in general good health at the time of study entry.

          -  The child's parent(s)/legal guardian must provide written informed consent.

          -  The child must be able to complete the follow-up visits through 120-150 days from last
             injection of study drug.

          -  Parent(s)/legal guardian of patient must have available telephone access.

        Exclusion Criteria:

          -  Hospitalized at the time of study entry (unless discharge is expected within 10 days
             after entry into the study)

          -  Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry
             (including continuous positive airway pressure [CPAP])

          -  Congenital heart disease (CHD) (children with medically or surgically corrected
             [closed] patent ductus arteriosus and no other CHD may be enrolled)

          -  Evidence of infection with hepatitis A, B, or C virus

          -  Known renal impairment, hepatic dysfunction, chronic seizure disorder, or
             immunodeficiency or HIV infection (a child of a mother with known HIV infection must
             be proven to be uninfected at the time of enrollment)

          -  Suspected serious allergic or immune-mediated events with prior receipt of palivizumab

          -  Acute illness or progressive clinical disorder

          -  Active infection, including acute RSV infection, at the time of enrollment

          -  Previous reaction to intravenous immunoglobulin (IGIV), blood products, or other
             foreign proteins

          -  Received within the past 120 days or currently receiving immunoglobulin products (such
             as RSV-IGIV [RespiGam], IVIG, or palivizumab) or any investigational agents

          -  Previous participation in a clinical trial of motavizumab

          -  Currently participating in any investigational study