CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
CSL Influenza Vaccinebiological
Likely dose
CSL Influenza Vaccine 45 mcgfrom 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/NCT01591837
NCT01591837Phase 4Completed
CompareCT.gov

A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2012/2013 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged 18 to 59 Years) and 'Older Adults' (Aged 60 Years or Older)

Seqirus·interventional·Posted May 4, 2012·Updated Jun 27, 2018

In Brief

A Phase 4 clinical trial evaluating CSL Influenza Vaccine for Influenza, Human. Completed, enrolled 120 participants across 1 site.

Detailed Summary

This is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or older.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2012
Enrollment StartMay 1, 2012
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.2 years ago

Interventions

CSL Influenza Vaccinebiological

The study vaccine (CSL Influenza Vaccine) is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2012/2013 influenza season). The vaccine will be administered by intramuscular or subcutaneous injection.