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Vaccine · 1 trial · 1 indication
To compare single booster vaccination (Arm A) to full revaccination (Arm B) in terms of immune response at 24 months post cancer directed systemic therapy in pediatric subjects who have received cancer directed systemic therapy for any malignancy.
| Arm | Type | Description |
|---|---|---|
| Arm A - Single booster vaccines | OTHER | Those subjects randomized to Arm A, single dose vaccine boosters, will receive non live vaccine boosters at the 3 month visit. Boosters for live vaccines will be given at the 6 month visit. Boosters will only be given as applicable for low titers tested at the baseline assessment visit. Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine. |
| Arm B - Staged revaccination series | OTHER | Those subjects randomized to Arm B, the full revaccination series, will receive applicable vaccines when titers are low (below normal range) at baseline. When indicated, non-live vaccines will be given at the 3, 6, and 9 month visits, live vaccines will be given at the 6 and 9 month visit. Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine. |
| Name | Type | Description |
|---|---|---|
| Vaccine | BIOLOGICAL | Patients will have lab evaluations for immune function at baseline, 3, 6, 9 and 24 months post completion of treatment. At 3 months off therapy, patients with abnormal vaccine antibody titers will be randomized to receive either single booster vaccines or to begin a full revaccination series that models post-hematopoietic stem cell transplant vaccination strategies. |
Inclusion Criteria: 1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian. 2. Age greater than or equal to 2 years and less than 22 years at the time of consent 3. Lansky/Karnofsky Perform...
Vaccine is an investigational therapy being studied for use in pediatric cancer. It is currently in Phase 2 clinical development, with an active trial evaluating immune function and response to vaccination after cancer therapy in pediatric patients. The drug is being developed by Atrium Therapeutics, Inc.
Vaccine is being developed by Atrium Therapeutics, Inc., a biopharmaceutical company. The company is conducting a Phase 2 clinical trial of the drug in pediatric cancer patients. Atrium Therapeutics is the sponsor of the ongoing study.
Vaccine is currently in Phase 2 clinical development. It is being studied in an active, recruiting clinical trial for pediatric cancer. The drug is investigational and has not yet been approved by regulatory authorities.
Vaccine is being studied in one active Phase 2 clinical trial, NCT04948619, titled 'Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients.' This trial is recruiting 64 participants in the United States, with a minimum age of 2 years.
Vaccine is the drug candidate being developed by Atrium Therapeutics, Inc. for pediatric cancer. It is currently in Phase 2 testing. The ongoing trial, NCT04948619, is evaluating immune function and response to vaccination after cancer therapy in pediatric patients.