High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant

Summary

This phase II randomized trial studies how well high dose flu vaccine works in treating children who have undergone done stem cell transplant. Higher dose flu vaccine may build a better immune response and may provide better protection against the flu than the standard vaccine.

Timeline

Start

2016-09

Primary completion

2021-12-01

Completion

2024-09

Outcome

Met primary endpoint

paper were more immunogenic than 2 doses of standard-dose quadrivalent influenza vaccine (SD-QIV). PMID 39279435 ↗

Publications

• Bahakel H, Spieker AJ, Hayek H, Schuster JE, Hamdan L, Dulek DE, Kitko CL, Stopczynski T, Batarseh E, Haddadin Z, Stewart LS, Stahl A, Potter M, Rahman H, Amarin J, Kalams SA, Bocchini CE, Moulton EA, Coffin SE, Ardura MI, Wattier RL, Maron G, Grimley M, Paulsen G, Harrison CJ, Freedman J, Carpenter PA, Englund JA, Munoz FM, Danziger-Isakov L, Halasa N; Pediatric HCT Flu Study. Immunogenicity and Reactogenicity of High- or Standard-Dose Influenza Vaccine in a Second Consecutive Influenza Season. J Infect Dis. 2025 Feb 4;231(1):e123-e131. doi: 10.1093/infdis/jiae454.
• Schuster JE, Hamdan L, Dulek DE, Kitko CL, Batarseh E, Haddadin Z, Stewart LS, Stahl A, Potter M, Rahman H, Kalams SA, Bocchini CE, Moulton EA, Coffin SE, Ardura MI, Wattier RL, Maron G, Grimley M, Paulsen G, Harrison CJ, Freedman JL, Carpenter PA, Englund JA, Munoz FM, Danziger-Isakov L, Spieker AJ, Halasa NB; Pediatric HCT Flu Study. The Durability of Antibody Responses of Two Doses of High-Dose Relative to Two Doses of Standard-Dose Inactivated Influenza Vaccine in Pediatric Hematopoietic Cell Transplant Recipients: A Multi-Center Randomized Controlled Trial. Clin Infect Dis. 2024 Jan 25;78(1):217-226. doi: 10.1093/cid/ciad534.

Drugs

Indications