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Immunogenicity, Safety, and Tolerability of an MF59-Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in Patients With Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus

NCT01032395 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2013-06-14

No results posted yet for this study

Summary

This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus, and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.

Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.

Conditions

  • H1N1 Influenza Virus
  • Chronic Pulmonary Disease
  • Chronic Heart Disease
  • Diabetes Mellitus

Interventions

BIOLOGICAL

Focetria®

7.5 ug of HA antigen; adjuvanted; monovalent

BIOLOGICAL

Fluad®

15 ug of HA antigen; adjuvanted; trivalent

BIOLOGICAL

Begrivac®

15 ug of antigen; non-adjuvanted; trivalent

Sponsors & Collaborators

  • Chiltern Pesquisa Clinica Ltda

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-10-31
Completion
2012-08-31

Countries

  • Brazil

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 NCT01032395 on ClinicalTrials.gov