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Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

NCT01262846 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2017-04-13

Study results available
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Summary

The overall goal of this study is to compare the safety and immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals. Our hypothesis is that Fluzone® HD will be safe and more immunogenic than the currently used vaccine

Conditions

  • HIV Infection

Interventions

BIOLOGICAL

Fluzone®

Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.

BIOLOGICAL

Fluzone®

Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.

Sponsors & Collaborators

Principal Investigators

  • PABLO TEBAS, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01262846 on ClinicalTrials.gov