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

NCT06054269 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-05-19

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

FLUAD Quadrivalent

0.5 mL intramuscular dose of FLUAD Quadrivalent

BIOLOGICAL

FluQuadri

0.5 mL intramuscular dose of FluQuadri

Sponsors & Collaborators

  • Peruvian Clinical Research

    collaborator OTHER

  • Hospital Nacional Cayetano Heredia

    collaborator UNKNOWN

  • Hospital Nacional Arzobispo Loayza

    collaborator OTHER

  • U.S. Naval Medical Research Unit No.6 (NAMRU-6)

    collaborator UNKNOWN

  • Centers for Disease Control and Prevention

    lead FED

Principal Investigators

  • Giselle Soto, MD, MPH · Naval Medical Research Unit- 6

  • Roger Antonio Hernandez Diaz, MD, MSc · Hospital Nacional Cayetano Heredia

  • Eduardo Demetrio Matos Prado, MD · Hospital Nacional Arzobispo Loayza

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2023-07-25
Completion
2026-05-04
FDA Drug
Yes

Countries

  • Peru

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06054269 on ClinicalTrials.gov