CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7,109 enrolled
Drug / intervention
MF59 adjuvanted trivalent subunit influenza vaccine (aTIV) +1 morebiological
Likely dose
MF59 adjuvanted trivalent subunit influenza vaccine (aTIV) 0.5 mLfrom 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/NCT01162122
NCT01162122Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity and the Consistency of Three Consecutive Lots of a MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects Aged 65 Years and Older

Novartis Vaccines·interventional·Posted Jul 14, 2010·Updated Jun 26, 2014

In Brief

A Phase 3 clinical trial evaluating MF59 adjuvanted trivalent subunit influenza vaccine (aTIV) and Non-adjuvanted trivalent subunit influenza vaccine (TIV) for Influenza. Completed, enrolled 7,109 participants across 38 sites in 4 countries.

Detailed Summary

The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesColombia, Panama, Philippines, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2010
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.0 years ago

Interventions

MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)biological

one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm

Non-adjuvanted trivalent subunit influenza vaccine (TIV)biological

one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm