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Safety and Immunogenicity of a Subunit Trivalent Influenza Vaccine, Northern Hemisphere Formulation 2013/2014, in Healthy Adults Aged 18 Years and Above

NCT01879553 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2014-03-12

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 in 2 age cohorts: 18 to ≤60 years and ≥61 years.

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

The vaccine composition will be based on the WHO-recommended influenza strains for the 2013/2014 Northern Hemisphere vaccine, and 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

TIV

Trivalent Influenza Virus Vaccine (surface antigen, inactivated, 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
18 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 NCT01879553 on ClinicalTrials.gov