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NCT01737710 · ClinicalTrials.gov registry record · NA

Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study

A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
NA
Development phase
368
Enrollment target

NCT01737710: Completed NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT01737710 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 368 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01737710, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
NA
Development phase
368 participants
Enrollment target

Study Summary

Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People who have atopic dermatitis often have complications from skin infections; these can include eczema herpeticum after herpes simplex virus infection or eczema vaccinatum after smallpox vaccination. People with atopic dermatitis may suffer from skin infections and may therefore respond differently to vaccinations. A new flu vaccine which is injected into the skin instead of into muscle has recently been approved by the Food and Drug Administration for vaccination of the general population including patients with atopic dermatitis. This new vaccine has been shown to work as well as the vaccine which is injected into muscle when tested in people without atopic dermatitis. The main purpose of this study is to compare how people with atopic dermatitis respond to this new flu vaccine compared to non-atopic volunteers without atopic dermatitis. The second purpose is to look at how people with atopic dermatitis respond to the new vaccine which is injected into the skin compared to the vaccine which is injected into muscle.

Primary Outcome

The difference in the percent of participants that achieved seroprotection against influenza B at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achi

Interventions

  • BIOLOGICAL Fluzone® Intradermal Vaccine
  • BIOLOGICAL Fluzone® (Intramuscular) vaccine

Trial Details

FieldValue
Enrollment Target 368 participants
Start Date 2012-10
Est. Completion 2013-05
Phase NA

What the finished NCT01737710 record still lists

NCT01737710 is an interventional study that assigns participants to a tested intervention. The registered 368 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 2 interventions - of which Fluzone® Intradermal Vaccine is the first listed.

NCT01737710 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01737710 about?

NCT01737710 is a clinical study titled "Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study". Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People who have atopic dermatitis often have complications from skin infections; these can include eczema herpeticum after herpes simplex virus infection or eczema vaccinatum after smallpox va...

What is the current status of trial NCT01737710?

This trial is currently completed. It is a NA study. The enrollment target is 368 participants. The study started on 2012-10. Estimated completion is 2013-05.

What interventions are being tested in trial NCT01737710?

The interventions under investigation include: Fluzone® Intradermal Vaccine (BIOLOGICAL), Fluzone® (Intramuscular) vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01737710?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01737710's enrollment target sits among peer trials

368 283rd of 2000 higher than 1,717 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 NCT01737710, the US trial registry maintained by the National Library of Medicine. NCT01737710 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.