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

NCT01949675 Phase 4 COMPLETED

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.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 4
Status	COMPLETED
Enrolment	336
Start date	2014-03
Completion	2015-08

Conditions

• Cholera

Interventions

• Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
• Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
• Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

Primary outcomes

• Number of participants reporting unsolicited systemic adverse events; solicited systemic reactions including serious adverse events following administration Oral Cholera Vaccine (Shanchol™) — 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™) — 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.

Countries

Philippines