CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 440 enrolled
Drug / intervention
Inflexal V influenza vaccine (CSL HA Antigen) 2010 +1 morebiological
Likely dose
Inflexal V influenza vaccine (CSL HA Antigen) 2010 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/NCT01229371
NCT01229371Phase 3Completed
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Randomized, Parallel-group, Double-blind Multi-center Phase III Study to Assess the Immunogenicity and Safety of the 2010/2011-season Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers, in Elderly and Young Adults

Crucell Holland BV·interventional·Posted Oct 27, 2010·Updated Sep 9, 2013

In Brief

A Phase 3 clinical trial evaluating Inflexal V influenza vaccine (CSL HA Antigen) 2010 and Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011 for Influenza. Completed, enrolled 440 participants across 2 sites.

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
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 27, 2010
Enrollment StartOct 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.7 years ago

Interventions

Inflexal V influenza vaccine (CSL HA Antigen) 2010biological

Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011, 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

Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011biological

Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 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