Safety and Immunogenicity of a Killed Oral Cholera Vaccine Among Infants 10 Weeks to Less Than 12 Months of Age When Given Concomitantly With EPI Vaccines

NCT00548054 Phase 2 UNKNOWN

In order to assess whether the bivalent killed oral cholera vaccine may be used safely among infants who are most at risk for cholera, the investigators need to determine the safety and immunogenicity of the killed oral cholera vaccine among infants less than 1 year of age when given with the expanded program on immunization (EPI) vaccines including diptheria, pertussis and tetanus (DPT), oral polio vaccine (OPV), Hepatitis B vaccines and measles vaccine. Furthermore, the investigators also need to make sure that immune interference does not occur among all the other vaccine antigens given at the same time. Findings from this study will pave the way for the possible use of the killed whole cell oral cholera vaccine (OCV).

Details

Lead sponsor	International Vaccine Institute
Phase	Phase 2
Status	UNKNOWN
Enrolment	300
Start date	2015-12
Completion	2016-12

Conditions

• Cholera
• Diarrhea
• Vibrio Infections

Interventions

• Bivalent killed oral cholera vaccine
• Killed Escherichia coli K12 placebo

Primary outcomes

• Safety: proportion of subjects with diarrhea — entire study period
• Immunogenicity: proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline — 14 days after each dose

Countries

India