Cholera Cholera
Conditions
Interventions
WC-OCV
Placebo
Sponsors
International Vaccine Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adults aged 18 years and above; and children aged 1 -17 years who is available for follow-up visits and specimen collection. a. The subject should be able to continue in the study for the next 4 weeks b. The subject (or parent/guardian)should be willing to provide 3 blood samples 2. For females of reproductive age, non pregnant (as determined by urine pregnancy test). 3.Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 ¿ 17 years. 4.Healthy subjects as determined by: a.Medical history b.Physical examination c.Clinical judgment of the investigator
Exclusion criteria
Exclusion criteria: 1. Ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician. 2. Ongoing acute illness. 3. For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening) 4. Immunocompromising condition or on chronic systemic steroid therapy 5. Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment 6. Intake of any anti-diarrhea medicine in the past week 7. Abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours 8. Temperature ¿38ºC (oral or axillary) warrants deferral of the vaccination pending recovery of the subject 9. Previous hypersensitivity to formaldehyde. 10. Receipt of immunoglobulin or any blood product during the past 3 months 11. Receipt of oral cholera vaccine in the past three years 12. Any potential subject currently participating or who will participate within the next six months in another clinical trial 13. Positive screening urine pregnancy test for females greater than 12 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects given investigational product with any of the following adverse events (immediate adverse events, any severe adverse events, reactogenicity);Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline;2. Geometric mean serum vibriocidal titers at baseline;Occurence of any severe adverse event | — |
Countries
Ethiopia
Contacts
Public ContactZenebe Akalu
Medical Doctor, Clinical Coordinator
Outcome results
None listed