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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: Completed Phase 2 study, sponsored by Novartis.
NCT00645411 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 3,604 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2610% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age. GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
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 |
What the finished NCT00645411 record still lists
NCT00645411 is an interventional study that assigns participants to a tested intervention. Its 3,604 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2610% higher).
The record links to 0 conditions, and to 2 interventions - of which Cell culture-derived influenza subunit vaccine (cTIV) is the first listed.
NCT00645411 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00645411's enrollment target sits among peer trials
3,604 6th of 2000 higher than 1,995 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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