Clinical Trial: Observational Study Describing the Immune Profile Induced By Pertussis Vaccines

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Characterization of Humoral and Cell-Mediated Immune Responses Following a Booster Dose of Pertussis Vaccine

Brief Summary: This is an observational study designed to describe the immune profile of toddlers and preschoolers with acellular priming after receiving a booster dose of pertussis vaccine.

Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome:

• Anti Pertussis antibody concentrations pre and post vaccination [ Time Frame: Day 30 post vaccination ]
  The change in antibody concentrations will be measured from pre to post vaccination
• Change in magnitude of T-cell responses to pertussis-containing combination vaccines over time [ Time Frame: Day 30 post vaccination ]
  The change in cell mediated immune responses will be evaluated from pre to post vaccination

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: May 8, 2017
Date Started: April 12, 2017
Date Completion: November 2017
Last Updated: May 9, 2017
Last Verified: May 2017