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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
- Sep 30, 2006
- Primary completion
- Feb 28, 2007
- Completion
- Sep 30, 2007
- Last update posted
- Nov 30, 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 Nov 30, 2011 · Synced Sep 15, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00391391 live on ClinicalTrials.gov.