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Systems Biology of Trivalent Influenza Vaccine (TIV) in Young and Elderly

NCT01232868 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2015-11-30

Study results available
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Summary

Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population.

In this trial, the investigators will study the immunologic differences of an FDA approved licensed influenza vaccine between a younger and an older group. Twenty two healthy volunteers between the age of 25-40 and forty four healthy volunteers above the age of 65 will be enrolled in the study. Each participant in the study will be given one flu shot. Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen days, as well as one month and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.

Conditions

Interventions

BIOLOGICAL

trivalent Influenza vaccine (TIV)

0.5 ml IM as a single dose in a prefilled syringe.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Nadine Rouphael, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01232868 on ClinicalTrials.gov