Influenza Clinical Trial
Official title:
A Phase II Study in Adults With Rheumatoid Arthritis Receiving TNF-alpha-inhibitor Therapy to Assess the Immunogenicity and Safety of Trivalent Inactivated Vaccine (TIV) and High Dose Trivalent Inactivated Vaccine (High-Dose TIV) Administered at Two Dosage Levels
A randomized, double-blinded, Phase II study in adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy aged 18 to 64 years of age and healthy gender-and age-matched control subjects . This study will investigate the immunogenicity, safety, and reactogenicity of two different doses of inactivated trivalent influenza virus vaccine (Sanofi Pasteur Fluzone [15 mcg x 3 strains] and Sanofi Pasteur Fluzone High Dose [60 mcg x 3 strains]) administered intramuscularly in individuals with rheumatoid arthritis receiving anti-TNF-alpha (TNFi) therapy and healthy age- and gender- matched controls.
This is a randomized, double-blinded, Phase II study in adults with Rheumatoid Arthritis receiving TNF-alpha inhibitor therapy, aged 18 years to 64 years of age. This study is designed to investigate the immunogenicity, safety, and reactogenicity of two different doses of inactivated trivalent influenza virus vaccine given at two dose levels (15 mcg and 60 mcg) administered IM in individuals with rheumatoid arthritis receiving anti-TNF-alpha therapy or age and gender matched control subjects. The study is conducted over two seasons, 2011-2012 and 2012-2013. Subjects enrolling between October 2011 and February 2012 will receive the 2011-2012 vaccine, while those enrolling after July 2012 will receive the 2012-2013 vaccine. Immunogenicity testing will determine the proportion of subjects in each group with titer a 4-fold rise in HAI titers (defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer >/=1:40 or a pre-vaccination HAI titer >/=1:10 and a minimum four-fold rise in post-vaccination HAI titer) against each of the specific influenza strains included in vaccine the subject received at day 21 following vaccination. The proportion of subjects in each group achieving a serum HAI titer of >/= 1:40 or a 4-fold rise in HAI titer or greater in HAI titer against each strain in the vaccine compared to the controls subjects. Safety testing will assess the occurrence of vaccine-associated Serious adverse events (SAEs) throughout the course of the study, and the occurrence of solicited local and systemic adverse events (AEs) within 8 days post vaccination. Solicited AEs (including rheumatoid arthritis clinical status) will be assessed during the course of the study. Subjects will have four face to face visits and one telephone contact. Day 0 will include the consent process, a medical history and physical exam for the RA subjects to assess the activity of their RA at the time of enrollment, vital signs, phlebotomy for prevaccine serology. Subjects will be randomized to receive IM seasonal TIV or High-Dose TIV at this visit and will receive the assigned vaccine. They will be observed for 20 minutes and will be taught to fill out a 7 day memory aid that will assess daily temperature, local and systemic reactogenicity. A telephone call will be made to assess reactogenicity and to review the memory aid on day 3. Subjects will return on day 7 for review of the memory aid, AEs/SAEs, vital signs and phlebotomy for serology. A physical exam will be performed if indicated. They will return on day 21 and at 6 months for review of AEs/SAEs, vital signs and phlebotomy for serology. A physical exam will be performed if indicated. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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