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Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers

NCT01412281 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2013-09-09

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Virosomal influenza vaccine (AdImmune HA Antigen)

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

BIOLOGICAL

Virosomal influenza vaccine (CSL HA Antigen)

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

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Michael Seiberling, MD · Covance Clinical Research Unit AG

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01412281 on ClinicalTrials.gov