drugset / Trial / NCT06054269

Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP

Phase 3 Completed 192 enrolled Centers for Disease Control and Prevention Hospital Nacional Arzobispo Loayza · collab Hospital Nacional Cayetano Heredia · collab Peruvian Clinical Research · collab U.S. Naval Medical Research Unit No.6 (NAMRU-6) · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This randomized, double-blinded trial will assess humoral immune responses to adjuvanted, egg-based quadrivalent influenza vaccines compared to standard dose, egg-based quadrivalent influenza vaccines among healthcare personnel (HCP). The trial will be conducted at two sites in Lima, Peru during 2022 and 2023.

Timeline

Start: 2022-11-04
Primary completion: 2023-07-25
Completion: 2026-05-04

Outcome

Mixed primary results

registry analysis (superiority test); FLUAD Quadrivalent vs FluQuadri; p = 0.004; Wilcoxon (Mann-Whitney) NCT06054269 ↗

registry analysis (superiority test); FLUAD Quadrivalent vs FluQuadri; p = 0.066; Wilcoxon (Mann-Whitney) NCT06054269 ↗

registry analysis (superiority test); FLUAD Quadrivalent vs FluQuadri; p <0.001; Chi-squared NCT06054269 ↗

registry analysis (superiority test); FLUAD Quadrivalent vs FluQuadri; p = 0.468; Chi-squared NCT06054269 ↗

Publications

Marcenac P, Soto G, Yau T, Carreon JD, Romero C, Gonzales M, La Rosa S, Arriola CS, Prouty M, Diaz RAH, Romero FA, Llanos-Cuentas A, Prado EDM, Silva M, Fowlkes A, Levine MZ, Azziz-Baumgartner E, Duca LM, Neyra J. Comparison of the immunogenicity of adjuvanted and conventional egg-based quadrivalent influenza vaccines among healthcare personnel in Lima, Peru: A randomized controlled trial. Int J Infect Dis. 2026 Jan;162:108205. doi: 10.1016/j.ijid.2025.108205. Epub 2025 Nov 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FLUAD Quadrivalent	Vaccine	0.5 ml	Intramuscular
Comparator	FluQuadri	Vaccine	0.5 ml	Intramuscular