NCT01031719

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Chiltern Pesquisa Clinica Ltda · Industry
• Sex: All
• Age: 2 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 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.

Conditions

• H1N1 Influenza Virus
• Invasive Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	adjuvanted A(H1N1) influenza vaccine	7.5 ug of HA antigen; adjuvanted; monovalent
BIOLOGICAL	non-adjuvanted A(H1N1) influenza vaccine	15ug of HA antigen, non-adjuvanted; trivalent
BIOLOGICAL	non-adjuvanted A(H1N1) influenza vaccine	15 mcg of antigen; non-adjuvanted; trivalent

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-09-01
• Completion: 2012-07-01
• First posted: 2009-12-15
• Last updated: 2012-09-13

Locations

3 sites across 1 country: Brazil