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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 Human Immunodeficiency Virus Type 1 (HIV-1) Infection 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


NCT number NCT01032408
Study type Interventional
Source Chiltern Pesquisa Clinica Ltda
Contact
Status Completed
Phase Phase 3
Start date April 2010
Completion date July 2012

See also
  Status Clinical Trial Phase
Completed NCT00978120 - Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma Phase 2
Completed NCT00992017 - Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women Phase 2
Completed NCT00992836 - Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth 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 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 Phase 3