CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 440 enrolled
Drug / intervention
Virosomal influenza vaccine (AdImmune HA Antigen) +1 morebiological
Likely dose
Virosomal influenza vaccine (AdImmune HA Antigen) 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/NCT01412281
NCT01412281Phase 3Completed
CompareCT.gov

Randomized, Parallel-group, Double-blind, Single-center Phase III Study to Assess the Immunogenicity and Safety of the 2011/2012-season Influenza Vaccine Formulated With HA Antigen From Two Suppliers, in Elderly and Young Adult Subjects Using the Current EMA Regulations as Guideline

Crucell Holland BV·interventional·Posted Aug 9, 2011·Updated Sep 9, 2013

In Brief

A Phase 3 clinical trial evaluating Virosomal influenza vaccine (AdImmune HA Antigen) and Virosomal influenza vaccine (CSL HA Antigen) for Influenza. Completed, enrolled 440 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesSwitzerland
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.9 years ago

Interventions

Virosomal influenza vaccine (AdImmune HA Antigen)biological

Virosomal influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA Antigen) 2011/2012, with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Virosomal influenza vaccine (CSL HA Antigen)biological

Virosomal influenza vaccine (surface antigen, inactivated, virosome, using CSL HA antigen) 2011/2012 with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus