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Also known as Synagis, ABT-315
Palivizumab · 2 trials · 2 indications
An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).
Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose).
| Arm | Type | Description |
|---|---|---|
| Children at High Risk of severe RSV Infection | EXPERIMENTAL | A single IM injection every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled. |
| Palivizumab | EXPERIMENTAL | 15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of severe respiratory syncytial virus (RSV) during the RSV season. |
| Name | Type | Description |
|---|---|---|
| Palivizumab | DRUG | Palivizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed to an epitope in the A antigenic site of the F (fusion) protein of RSV. |
Inclusion Criteria: Infants at high risk of severe RSV infection defined as fulfilling at least one of the following: * Infants born ≤ 35 weeks gestational age AND are ≤ 6 months of age at enrollment * Infants ≤ 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (BPD...
Palivizumab is used to prevent serious respiratory syncytial virus (RSV) infection in children at high risk of severe disease. It is studied in newborns, infants, and young children, including those with immunocompromising medical conditions. Its development focuses on RSV prevention in pediatric populations.
Palivizumab is developed by AbbVie Inc., which trades under the ticker ABBV. The company has sponsored Phase 3 clinical studies of the monoclonal antibody in pediatric patients at high risk of severe RSV infection.
Palivizumab is in Phase 3 clinical development. It is an investigational monoclonal antibody, and the completed Phase 3 trials evaluated its safety and effectiveness in children at high risk of severe RSV infection. It has not been approved by the FDA based on the available development data.
Palivizumab has been studied in completed Phase 3 trials, including NCT02968173, which assessed its safety and effectiveness in children at high risk of severe RSV in the Russian Federation and Belarus, and NCT01466062, which evaluated it in Japanese newborns, infants, and young children with immunocompromising conditions.
Palivizumab is a monoclonal antibody, a type of antibody therapy. It is designed to target respiratory syncytial virus (RSV) to help prevent severe RSV infection in high-risk pediatric patients. Its mechanism involves antibody-mediated activity against the virus.