Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
Public ClinicalTrials.gov record NCT00391391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Healthy Infants and Young Children.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: * To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. * To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
Study identification
- NCT ID
- NCT00391391
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 520 participants
Conditions and interventions
Interventions
- Split, Inactivated, Trivalent Influenza Vaccine Biological
- Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Months to 8 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
- Oct 2006 (Type not available)
- Primary completion
- Mar 2007 (Actual)
- Completion
- Oct 2007 (Actual)
- Last update posted
- Dec 1, 2011
2006 – 2007
United States locations
- U.S. sites
- 19
- U.S. states
- 9
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Harrisburg | Arkansas | 72432 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Trumann | Arkansas | 72472 | — |
| Not listed | Bellflower | California | 90706 | — |
| Not listed | Downey | California | 90241 | — |
| Not listed | Fountain Valley | California | 92708 | — |
| Not listed | Paramount | California | 90723 | — |
| Not listed | Owensboro | Kentucky | 42303 | — |
| Not listed | Bossier City | Louisiana | 71111 | — |
| Not listed | Shreveport | Louisiana | 71105 | — |
| Not listed | Brainerd | Minnesota | 56401 | — |
| Not listed | Cleveland | Ohio | 44121 | — |
| Not listed | Erie | Pennsylvania | 16505 | — |
| Not listed | Pittsburgh | Pennsylvania | 15277 | — |
| Not listed | Uniontown | Pennsylvania | 15401 | — |
| Not listed | Wexford | Pennsylvania | 15090 | — |
| Not listed | Fort Worth | Texas | 76107 | — |
| Not listed | Salt Lake City | Utah | 84109 | — |
| Not listed | Salt Lake City | Utah | 84121 | — |
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 NCT00391391, 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 Dec 1, 2011 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00391391 live on ClinicalTrials.gov.