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Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP - Trial NCT06054269

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.

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NCT06054269
Phase 3
Recruitment Completed
biological
Trial Details
ClinicalTrials.gov โ€ข NCT06054269
View on ClinicalTrials.gov
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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)

Study Focus

Influenza

FLUAD Quadrivalent

Interventional

biological

Sponsor & Location

Centers for Disease Control and Prevention

Lima,Lima, Peru

Timeline & Enrollment

Phase 3

Nov 04, 2022

Nov 04, 2023

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 pneumonia
Influenza due to identified seasonal influenza virus
Influenza with other manifestations, seasonal influenza virus identified
Influenza with pneumonia, seasonal influenza virus identified
Influenza due to identified zoonotic or pandemic influenza virus

Data Source

ClinicalTrials.gov

NCT06054269

Non-Device Trial