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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: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00858468 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 394 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (557% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
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 |
What the finished NCT00858468 record still lists
NCT00858468 is an interventional study that assigns participants to a tested intervention. The registered 394 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (557% higher).
The record links to 0 conditions, and to 1 intervention - of which Influenza virus vaccine (2004-2005 Formulation) is the first listed.
NCT00858468 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00858468's enrollment target sits among peer trials
394 77th of 2000 higher than 1,924 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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