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NCT00858468 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 394
- Enrollment target
NCT00858468 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 394 participants.
The verdict
NCT00858468, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 394 participants
- Enrollment target
Study Summary
Primary Objective: To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups. Observational Objective: To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.
Interventions
- BIOLOGICAL Influenza virus vaccine (2004-2005 Formulation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 394 participants |
| Start Date | 2005-04 |
| Est. Completion | 2006-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00858468
The ClinicalTrials.gov registry entry for NCT00858468 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 394 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Influenza virus vaccine (2004-2005 Formulation) is the first listed.
NCT00858468 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00858468 about?
NCT00858468 is a clinical study titled "Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age". Primary Objective: To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups. Observational O...
What is the current status of trial NCT00858468?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 394 participants. The study started on 2005-04. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00858468?
The interventions under investigation include: Influenza virus vaccine (2004-2005 Formulation) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00858468?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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