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Safety and Immunogenicity of a Subunit Trivalent Influenza Vaccine, Northern Hemisphere Formulation 2013/2014, Including MF59C.1 Adjuvant, in Healthy Adults ≥65 Years of Age

NCT01879540 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2014-03-26

Study results available
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Summary

The present study is designed to confirm the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant, formulation 2013/2014 Northern Hemisphere, in adults ≥65 years of age.

For the immunogenicity endpoints the antibody response to each influenza vaccine antigen, will be measured by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post immunization.

The vaccine composition will be based on the World Health Organization (WHO) recommended influenza strains for 2013/2014 Northern Hemisphere.

The results of this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same, in compliance with the requirements of the current European Union (EU) recommendations for clinical trials related to yearly licensing of influenza vaccines.

Conditions

  • Human Influenza

Interventions

BIOLOGICAL

aTIV

Adjuvanted Trivalent Influenza Virus Vaccine (surface antigen, inactivated, adjuvanted with MF59C.1, egg-derived)

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines and Diagnostics · Novartis Vaccines

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Belgium

Study Locations

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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 NCT01879540 on ClinicalTrials.gov