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NCT00645411 · ClinicalTrials.gov registry record · Phase 2
Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents
A Phase 2 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 2
- Development phase
- 3,604
- Enrollment target
NCT00645411 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 3,604 participants.
The verdict
NCT00645411, a Phase 2 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3,604 participants
- Enrollment target
Study Summary
The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).
Interventions
- BIOLOGICAL Cell culture-derived influenza subunit vaccine (cTIV)
- BIOLOGICAL Egg derived influenza subunit vaccine (eTIV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,604 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00645411
The ClinicalTrials.gov registry entry for NCT00645411 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 3,604 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cell culture-derived influenza subunit vaccine (cTIV) is the first listed.
NCT00645411 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00645411 about?
NCT00645411 is a clinical study titled "Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents". The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and...
What is the current status of trial NCT00645411?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3,604 participants. The study started on 2007-10. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00645411?
The interventions under investigation include: Cell culture-derived influenza subunit vaccine (cTIV) (BIOLOGICAL), Egg derived influenza subunit vaccine (eTIV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00645411?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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