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Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

NCT01162122 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7109

Last updated 2014-06-26

Study results available
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Summary

The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.

Conditions

Interventions

BIOLOGICAL

MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)

one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm

BIOLOGICAL

Non-adjuvanted trivalent subunit influenza vaccine (TIV)

one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-08-31
Completion
2011-11-30

Countries

  • United States
  • Colombia
  • Panama
  • Philippines

Study Locations

More Related Trials

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 NCT01162122 on ClinicalTrials.gov