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

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

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

Summary

Timeline

Publications

Drugs

Indications