NCT01032395

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

A Phase 3, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Chiltern Pesquisa Clinica Ltda · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-10-01
• Completion: 2012-08-01
• First posted: 2009-12-15
• Last updated: 2013-06-14

Locations

2 sites across 1 country: Brazil