CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,116 enrolled
Drug / intervention
TIV +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01209780
NCT01209780Phase 3Completed
CompareCT.gov

A Multi-center, Phase III, Randomized, Observer Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of a Trivalent Subunit Inactivated Flu Vaccine in Healthy Children and Adolescents 3 to 17 Years of Age

Novartis Vaccines·interventional·Posted Sep 27, 2010·Updated Mar 11, 2014

In Brief

A Phase 3 clinical trial evaluating TIV, TIVf, and 1 other intervention for Seasonal Influenza. Completed, enrolled 3,116 participants across 13 sites in 4 countries.

Detailed Summary

This study will evaluate the safety and immunogenicity in healthy children and adolescents after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Influenza
CountriesColombia, Mexico, Panama, Philippines
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2010
Enrollment StartSep 1, 2010
Primary CompletionMar 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.8 years ago

Interventions

TIVbiological

Investigational egg-derived trivalent subunit influenza vaccine.

TIVfbiological

US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years.

Comparator TIVbiological

US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children \<4 years.