A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT02543918
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ixekizumab — DRUG
    Administered by SQ injection
  • Boostrix® — DRUG
    Administered by IM injection
  • Pneumovax®23 — DRUG
    Administered by IM injection

Study Details

The purpose of this study is to compare the body's immune response when vaccines are given alone versus when vaccines are given along with the study drug called ixekizumab. The vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with follow-up at 12 weeks.

Key Dates

Start date
Sep 30, 2015
Status verified
Nov 2016
Primary completion
Nov 30, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Ixekizumab + Boostrix® + Pneumovax®23
    Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
  • Other: Boostrix® + Pneumovax®23
    Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.

Primary Outcome Measure

Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations [ Time Frame: Week 6 ]

Locations (3)

FacilityCityStateZIPSite coordinators
CovanceDaytona BeachFlorida32117-
CovanceEvansvilleIndiana47710-
CovanceDallasTexas75247-

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