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NCT06054269

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

Randomized Controlled Trial, Double Blind, Phase III, to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among Health Care Personnel (EDUCATE)
Centers for Disease Control and Prevention·Phase 3·ClinicalTrials.gov·biologicalRecruitment Completed
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Influenza
Drug/Device/Intervention
FLUAD Quadrivalent
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Centers for Disease Control and Prevention
Location
Lima,Lima, Peru
Timeline & enrollment
Phase
Phase 3
Start date
Nov 04, 2022
End date
Nov 04, 2023
Enrollment
192 participants
Primary outcome

Hemagglutination inhibition (HI) geometric mean titers (GMT) pre- (Day 0) and post-vaccination (Day 28) of each vaccine reference virus,HI GMT pre- (Day 0) and post-vaccination (6 months),Geometric Mean Fold Rise (MFR) of each vaccine reference virus post-vaccination,MFR of each vaccine reference virus post-vaccination,Seroconversion rate (SCR) of each vaccine reference virus post-vaccination,SCR of each vaccine reference virus post-vaccination

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.

ICD-10 classifications
Influenza and pneumoniaInfluenza due to identified seasonal influenza virusInfluenza with other manifestations, seasonal influenza virus identifiedInfluenza with pneumonia, seasonal influenza virus identifiedInfluenza due to identified zoonotic or pandemic influenza virus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06054269
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06054269 through Pure Global AI's free database. This Phase 3 trial is sponsored by Centers for Disease Control and Prevention and is currently Recruitment Completed. The study focuses on Influenza. Target enrollment is 192 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.