Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Motavizumab · 4 trials · 4 indications
An RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive central real-time reverse transcription polymerase chain reaction (RT-PCR) RSV test collected within 3 days of hospitalization or 2) new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test.
Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
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.
Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing
Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive IM dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season. |
| Motavizumab | ACTIVE_COMPARATOR | Participants will receive IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season. |
| Pailvizumab | ACTIVE_COMPARATOR | Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. |
| motavizumab (MEDI-524) 15 mg/kg | EXPERIMENTAL | A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. |
| palivizumab 15 mg/kg | ACTIVE_COMPARATOR | A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. |
| Motavizumab, 3 mg/kg as a single intravenous dose | EXPERIMENTAL | Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0 |
| Motavizumab, 15 mg/kg as a single intravenous dose | EXPERIMENTAL | Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0 |
| Motavizumab, 30 mg/kg as a single intravenous dose | EXPERIMENTAL | Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0 |
| Placebo, as a single intravenous dose | PLACEBO_COMPARATOR | Placebo, as a single intravenous dose administered on Day 0 |
| Name | Type | Description |
|---|---|---|
| Motavizumab | BIOLOGICAL | Intramuscular dose of motavizumab 15 mg/kg will be administered every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season. |
| Placebo | OTHER | Intramuscular dose of placebo matched to motavizumab will be administered every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season. |
| Palivizumab | BIOLOGICAL | 15 mg/kg IM administered at monthly intervals |
| motavizumab (MEDI-524) | BIOLOGICAL | Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections. |
| palivizumab 15 mg/kg | BIOLOGICAL | Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections. |
Inclusion Criteria: * 6 months of age or younger at randomization (child must be randomized on or before their 6-month birthday) * Male or female Native American * General state of good health * Written informed consent obtained from the participant's parent(s) or legal guardian Exclusion Criteria...
Motavizumab is an investigational monoclonal antibody being studied for the prevention of Respiratory Syncytial Virus (RSV) disease. It has been evaluated in clinical trials for RSV prophylaxis in children, including those with congenital heart disease and healthy Native American Indian infants. It is not approved and remains in clinical development.
Motavizumab targets Respiratory Syncytial Virus (RSV). It is a monoclonal antibody designed to neutralize the virus and prevent RSV infection. Clinical trials have assessed its safety and efficacy in preventing RSV disease in pediatric populations.
Motavizumab is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca has conducted clinical trials to evaluate the drug's safety and efficacy for RSV prophylaxis.
Motavizumab is in Phase 2 clinical development. It has completed multiple trials, including Phase 1, Phase 2, and Phase 3 studies. However, it remains investigational and is not yet approved by regulatory authorities for any indication.
Motavizumab has been studied in several completed clinical trials, including NCT00113490, NCT00121108, NCT00192504, and NCT00538785. These trials evaluated its use for RSV prophylaxis in children, including those with congenital heart disease and healthy infants.
Yes, Motavizumab is also known as MEDI-524. Clinical trial records refer to the drug by both names, with studies such as NCT00113490 and NCT00538785 evaluating MEDI-524 (Motavizumab) for RSV prophylaxis.