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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: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00885105 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 242 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
Interventions
- BIOLOGICAL Influenza Virus Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2005-10 |
| Est. Completion | 2007-09 |
| Phase | Phase 3 |
What the finished NCT00885105 record still lists
NCT00885105 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 1 intervention - of which Influenza Virus Vaccine is the first listed.
NCT00885105 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00885105's enrollment target sits among peer trials
242 1270th of 2000 higher than 729 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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