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NCT01857206 · ClinicalTrials.gov registry record · Phase 3
Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
A Phase 3 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,055
- Enrollment target
NCT01857206: Completed Phase 3 study, sponsored by Novartis Vaccines.
NCT01857206 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 2,055 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (166% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01857206, a Phase 3 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,055 participants
- Enrollment target
Study Summary
Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.
Primary Outcome
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Interventions
- BIOLOGICAL Mammalian cell based flu vaccine
- BIOLOGICAL Egg based flu vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,055 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01857206 record still lists
NCT01857206 is an interventional study that assigns participants to a tested intervention. Its 2,055 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (166% higher).
The record links to 0 conditions, and to 2 interventions - of which Mammalian cell based flu vaccine is the first listed.
NCT01857206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01857206 about?
NCT01857206 is a clinical study titled "Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age". Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.
What is the current status of trial NCT01857206?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,055 participants. The study started on 2013-05. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01857206?
The interventions under investigation include: Mammalian cell based flu vaccine (BIOLOGICAL), Egg based flu vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01857206?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01857206's enrollment target sits among peer trials
2,055 99th of 2000 higher than 1,902 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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