Clinical Trial to Compare the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Influenza Vaccine Versus Non-Adjuvanted A(H1N1) Influenza Vaccines in Patients With Invasive Solid Tumors

H1N1 Influenza Virus Clinical Trial

Official title:
A Phase III, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Vaccine Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Invasive Solid Tumors

Status Completed

Clinical Trial 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 Solid Invasive Tumors 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01031719
Study type	Interventional
Source	Chiltern Pesquisa Clinica Ltda
Contact
Status	Completed
Phase	Phase 3
Start date	August 2010
Completion date	July 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00978120` - Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma	Phase 2
Completed	`NCT00992836` - Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth	Phase 2
Completed	`NCT00992017` - Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women	Phase 2
Completed	`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	Phase 3
Enrolling by invitation	`NCT01277380` - Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR	N/A
Completed	`NCT01032408` - Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in Patients With HIV-1 Infection	Phase 3