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NCT01232868 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Emory University.

Completed
Registry status
NA
Development phase
66
Enrollment target

NCT01232868: Completed NA study, sponsored by Emory University.

NCT01232868 is a NA study that has completed, run by Emory University. The registered enrollment target is 66 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01232868, a NA study, has completed, sponsored by Emory University.

COMPLETED
Registry status
NA
Development phase
66 participants
Enrollment target

Study 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.

Primary Outcome

The number of subjects with a change in innate immunity signatures correlating with the level of antibodies was recorded. The innate immune signatures were assessed by Fluorescence Activated Cell Sorting (FACS)/Luminex assays. The levels of antibodies to the influenza virus prior to TIV (trivalent influenza vaccine) administration and on Day 180 after receiving TIV was assessed and the number of subjects who exhibited an increase in the antibodies and, therefore, a change in their innate immune

Interventions

  • BIOLOGICAL trivalent Influenza vaccine (TIV)

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2010-10
Est. Completion 2011-10
Phase NA
Emory University

1,208 total trials

What the finished NCT01232868 record still lists

NCT01232868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which trivalent Influenza vaccine (TIV) is the first listed.

NCT01232868 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01232868 about?

NCT01232868 is a clinical study titled "Systems Biology of Trivalent Influenza Vaccine (TIV) in Young and Elderly". 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....

What is the current status of trial NCT01232868?

This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2010-10. Estimated completion is 2011-10.

What interventions are being tested in trial NCT01232868?

The interventions under investigation include: trivalent Influenza vaccine (TIV) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01232868?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01232868's enrollment target sits among peer trials

66 1139th of 2000 higher than 857 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01232868, the US trial registry maintained by the National Library of Medicine. NCT01232868 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.