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 ]

Solicited injection-site: Pain, Redness, Swelling, Change in limb circumference and Extensive limb swelling. Solicited systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia. Unsolicited adverse events; medically-attended adverse events and serious adverse events will also be collected


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