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A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.
Phase II, Double-blind, two-period, cross-over study to be conducted at 20 sites the U.S. A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence: Sequence A (single dose of the liquid formulation on Study Day 0 and a single dose of the lyophilized formulation on Study Day 30) or Sequence B (single dose of the lyophized forumation on Study Day 0 and single dose of the liquid formulation on Study Day 30). Children will be followed for adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-493 | Drug | Active Comparator |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and serious adverse events for 30 days after each injection of study drug. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Genevieve Losonsky, M.D. | "Unaffliliated" | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Packard Children's Hospital at Stanford | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D000069455 | Palivizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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