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NCT00885105 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 242
- Enrollment target
NCT00885105 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 242 participants.
The verdict
NCT00885105, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 242 participants
- Enrollment target
Study Summary
The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine. Observational Objectives: * To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.
Interventions
- BIOLOGICAL Influenza Virus Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2005-10 |
| Est. Completion | 2007-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00885105
The ClinicalTrials.gov registry entry for NCT00885105 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 242 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 is the first listed.
NCT00885105 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00885105 about?
NCT00885105 is a clinical study titled "Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age". The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine. Observational Objectives: * To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each...
What is the current status of trial NCT00885105?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 242 participants. The study started on 2005-10. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00885105?
The interventions under investigation include: Influenza Virus Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00885105?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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