MedTrace Logo

Study of Inactivated, Split-Virion Influenza Vaccine Compared With the Reference Vaccine Vaxigrip® in the Elderly

NCT00383526 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3707

Last updated 2014-01-14

No results posted yet for this study

Summary

Vaccination against influenza is a high priority for the elderly population who present the highest morbidity and mortality rate. However, due to their weak antibody response an improvement of the immune response to influenza vaccination remains an unmet medical need. The purpose of an investigational influenza vaccine candidate administered by an alternate route is to improve immune responses to the vaccine in the elderly population, which could provide additional reductions in influenza-associated morbidity and mortality in this population.

Primary Objective:

To demonstrate that the investigational vaccine induces a better immunogenicity than the reference vaccine in terms of seroprotection rate after the first vaccination.

Secondary Objectives:

Immunogenicity:

To describe the antibody persistence induced by both vaccines at 3, 6, and 12 months after the first vaccination in a subset of subjects.

To describe the immunogenicity of the investigational vaccine after each vaccination using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96) specific to elderly subjects.

Safety:

To demonstrate the tolerance of the investigational vaccine after the first vaccination, in terms of pre-defined solicited systemic reactions.

To describe the safety profile after each vaccination. To describe the effect of repetitive injections on the safety profile.

Conditions

  • Orthomyxoviridae Infection
  • Influenza
  • Myxovirus Infection

Interventions

BIOLOGICAL

Inactivated, split-virion influenza vaccine

Vaccine

BIOLOGICAL

Inactivated, split-virion influenza vaccine

Vaccine

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-06-30
Completion
2009-09-30

Countries

  • Belgium
  • France
  • Italy
  • Lithuania

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 NCT00383526 on ClinicalTrials.gov