CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled
Drug / intervention
Trivalent inactivated influenza vaccine +1 morebiological
Likely dose
Trivalent inactivated influenza vaccine 60 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01436370
NCT01436370Phase 2Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Sep 19, 2011·Updated Dec 24, 2014

In Brief

A Phase 2 clinical trial evaluating Trivalent inactivated influenza vaccine for Influenza. Completed, enrolled 102 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 19, 2011
Enrollment StartOct 1, 2011
Primary CompletionFeb 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.8 years ago

Interventions

Trivalent inactivated influenza vaccinebiological

Inactivated trivalent influenza virus vaccine (Sanofi Pasteur Fluzone® High Dose \[60 mcg x 3 strains\]), as a single intramuscular dose. 80 and up to 100 subjects. Subjects enrolling between October 2011 and February 2012 will receive the 2011-2012 vaccine and subjects enrolling after July 2012 will receive the 2012-2013 vaccine.

Trivalent inactivated influenza vaccinebiological

Inactivated trivalent influenza virus vaccine (Sanofi Pasteur Fluzone® \[15 mcg x 3 strains\]), as a single intramuscular dose. 80 and up to 100 subjects. Subjects enrolling between October 2011 and February 2012 will receive the 2011-2012 vaccine and subjects enrolling after July 2012 will receive the 2012-2013 vaccine.