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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

NCT01031719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2012-09-13

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 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

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

Sponsors & Collaborators

  • Chiltern Pesquisa Clinica Ltda

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-09-30
Completion
2012-07-31

Countries

  • Brazil

Study Locations

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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 NCT01031719 on ClinicalTrials.gov