Clinical Trial: Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults
Brief Summary:
This is a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the US.
Primary Objective
- To describe the safety profile of each SP0173 investigational formulation.
Observational Objective:
- To describe the immunogenicity of each SP0173 investigational formulation.
Detailed Summary: All subjects will receive a single dose of vaccine, and will be assessed for immunogenicity at baseline (pre-vaccination) and at 30 days post-vaccination. They will also be monitored for safety from day of vaccination up to Day 180 post-vaccination.
Sponsor: Sanofi Pasteur, a Sanofi Company
Current Primary Outcome: Number of participants reporting solicited reactions, unsolicited adverse events and serious adverse events following vaccination in all groups. [ Time Frame: Day 0 up to Day 180 post-vaccination ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: October 22, 2015
Date Started: October 2015
Date Completion: November 2017
Last Updated: August 17, 2016
Last Verified: August 2016