Immunogenicity and Safety of Different Doses of Fluzone® Influenza

ClinicalTrials.gov ID: NCT00253734

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Official title

Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route Compared to an Intramuscular Vaccination With Fluzone® in Healthy Adults

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. If using smaller doses in this manner is effective, the current supply of vaccine could be used to make more doses to give to more people. About 217 healthy adults, 18 to 49 years of age, will participate. The study will be conducted at one site in the United States and subjects are expected to participate for about 6 months. Blood samples will be taken to assess the immune system response. Local and systemic safety will be evaluated in the 28 days following vaccination.

Study identification

NCT ID: NCT00253734
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID); NIH
Enrollment: 217 participants

Conditions and interventions

Conditions

Influenza

Interventions

Fluzone® (IM) Biological
Fluzone® Biological

Biological

Eligibility (public fields only)

Age range: 18 Years to 49 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 2005 (Type not available)
Primary completion: Oct 2006 (Actual)
Completion: Nov 2006 (Actual)
Last update posted: Jun 3, 2013

2005 – 2006

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Saint Louis University	St Louis	Missouri	63110	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00253734, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 3, 2013 · Synced Nov 15, 2026