Clinical Trial: A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety and Immunogenicity of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines

Brief Summary:

The aim of the study is to generate safety and immunogenicity data with Oral Cholera Vaccine (Shanchol™) in The Philippines

Objectives:

  • To describe the safety after each dose of Shanchol vaccine.
  • To describe the immunogenicity after each dose of Shanchol vaccine.

Detailed Summary: Healthy toddlers, children, adolescents and adults, aged 1 year and older will receive two doses of vaccine 14 days apart, and will be assessed baseline immunogenicity (pre-vaccination), and 14 days after each vaccine dose. Safety data will be collected for 14 days after the first dose and 30 days after the second dose.
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome:

  • Number of participants reporting unsolicited systemic adverse events; solicited systemic reactions including serious adverse events following administration Oral Cholera Vaccine (Shanchol™) [ Time Frame: Day 0 up to Day 44 post oral vaccination ]
    Solicited systemic reaction: Vomiting, Diarrhea, Fever (temperature), Abdominal pain, Itching, Rash, Weakness, Cough, Vertigo, and Dryness of Mouth
  • Summary of titers of serum vibriocidal antibodies Before and 14 days after each Oral Cholera Vaccine (Shanchol™) [ Time Frame: Day 0 (before) and Day 14 post oral vaccination ]
    Serum vibriocidal antibody (against V. cholerae O1 Inaba serogroup, V. cholerae O1 Ogawa serogroup, and V. cholerae O139 serogroup) will be assessed using the microtiter technique.


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of participants with 4-fold or greater rises in titers 14 days after each Oral Cholera Vaccine (Shanchol™) relative to baseline [ Time Frame: Day 0 (before) and Day 14 post oral vaccination ]

Serum vibriocidal antibody (against V. cholerae O1 Inaba serogroup, V. cholerae O1 Ogawa serogroup, and V. cholerae O139 serogroup) will be assessed using the microtiter technique.


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: September 20, 2013
Date Started: March 2014
Date Completion:
Last Updated: September 3, 2015
Last Verified: September 2015