CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 114 enrolled
Drug / intervention
Inflexal Vbiological
Likely dose
Inflexal V 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/NCT01306253
NCT01306253Phase 4Completed
CompareCT.gov

Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2009/2010-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations

Crucell Holland BV·interventional·Posted Mar 1, 2011·Updated Sep 9, 2013

In Brief

A Phase 4 clinical trial evaluating Inflexal V for Influenza. Completed, enrolled 114 participants across 1 site.

Detailed Summary

This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines.

Study Details

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

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 1, 2011
Enrollment StartJun 1, 2009
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 15.3 years ago

Interventions

Inflexal Vbiological

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: * 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus * 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus * 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1