Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Motavizumab, palivizumab · 2 trials · 3 indications
RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).
Number of participants reporting one or more AEs
Number of participants reporting one or more AEs considered related to study drug by the investigator
Number of participants reporting one or more SAEs
Number of participants reporting one or more SAEs considered related to study drug by the investigator
Adverse events events were graded by severity; Level 1, 2, 3, or 4
Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs
Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.
| Arm | Type | Description |
|---|---|---|
| palivizumab | ACTIVE_COMPARATOR | 15 mg/kg administered intramuscularly for 5 monthly doses |
| motavizumab (MEDI-524) | EXPERIMENTAL | 15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses |
| Motavizumab followed by Palivizumab | EXPERIMENTAL | 2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Palivizumab followed by motavizumab | EXPERIMENTAL | 2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Motavizumab control | EXPERIMENTAL | 5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Name | Type | Description |
|---|---|---|
| motavizumab (MEDI-524) | BIOLOGICAL | Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses |
| palivizumab | BIOLOGICAL | Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses |
| Motavizumab, palivizumab | BIOLOGICAL | 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, motavizumab | BIOLOGICAL | 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 | BIOLOGICAL | 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. |
Inclusion Criteria: * 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) wit...
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.