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

Chiltern Pesquisa Clinica Ltda3 sites in 1 country59 target enrollmentAugust 2010

ConditionsH1N1 Influenza Virus Invasive Solid Tumors

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: H1N1 Influenza Virus
Sponsor: Chiltern Pesquisa Clinica Ltda
Enrollment: 59
Locations: 3
Primary Endpoint: The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with invasive solid tumors
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

July 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chiltern Pesquisa Clinica Ltda

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For Invasive Solid Tumor Subjects:
•Subjects between 2 and 70 years of age (inclusive)
•Any sex or ethnicity
•Confirmed diagnosis of Invasive Solid Tumor or hematological malignancies in complete remission for at least 3 months and not more than 18 months after the last neo-adjuvant and/or adjuvant chemotherapy cycle according to investigators assessment and the subjects medical records
•Previous use of neo-adjuvant and/or adjuvant chemotherapy for the treatment on an invasive solid tumor
•Life expectancy of at least 12 months
•Karnofsky Performance Scale \> 40%
•Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
•Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
•Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole intercourse

Exclusion Criteria

•For Invasive Solid Tumor Subjects:
•Previous laboratory confirmed diagnosis of an infection by the novel H1N1 virus
•Administration of other vaccine against the novel H1N1 virus within 3 months prior to inclusion in the study
•Any recent vaccine given within the last 21 days (inclusive)
•History of allergic reaction to an influenza vaccine in the past, or a current or previous occurrence of allergy to egg or egg protein, kanamycin, and neomycin sulfate
•Acute febrile disease (vaccination may be delayed up to 3 days after the resolution of the symptoms)
•Presence of other diseases, not related to cancer with confirmed immunosuppression
•Chemotherapy, biologic therapy or radiation within 3 months prior to inclusion in the study
•History of chronic hepatic or renal disease
•History of cognitive disorders

Outcomes

Primary Outcomes

The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with invasive solid tumors

Time Frame: 3 months

Secondary Outcomes

Assess whether the adjuvanted vaccine offers a meaningful benefit in relation to the non-adjuvanted vaccine in this at-risk population(3 months)
Assess whether two doses of either study vaccine will provide meaningful benefit in comparison to one dose(3 months)
Assess the persistence of antibody levels in the two vaccine groups(3 months)
Gain further insight into the safety of the adjuvanted and non-adjuvanted H1N1 vaccines in this high-risk patient population(3 months)