Study of Alternative Vaccination Schedule of Oral Cholera Vaccine (NCT01233362) | Clinical Trial Compass
CompletedPhase 2
Study of Alternative Vaccination Schedule of Oral Cholera Vaccine
India386 participantsStarted 2010-12
Plain-language summary
The absence of a boosting response after a 14 day interval with the two-dose regimen of the modified killed oral cholera vaccine raises the possibility that a longer dosing interval may be required to observe a boost in the immune response. This study will compare the immune responses following 14-day and 28-day dosing intervals.
Who can participate
Age range1 Year
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Healthy, non-pregnant adults aged 18 years and above and healthy children aged 1 - 17 will be recruited in Kolkata.
Inclusion Criteria:
* Males or non-pregnant females aged 18 years and above and children aged 1 -17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).
* Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 - 17 years.
* Healthy subjects as determined by:
* Medical history
* Physical examination
* Clinical judgment of the investigator
Exclusion Criteria:
* Ongoing serious chronic disease
* For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
* Immunocompromising condition or therapy (for corticosteroids this would mean ≥0.5 mg/kg/day)
* Diarrhea (3 or more loose/watery stools within a 24-hour period) 6 weeks prior to enrollment
* One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
* One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
* Intake of any anti-diarrhea medicine in the past week
* Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
* Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC warrants deferral of the vaccination pending recovery of …
What they're measuring
1
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after last dose of study agent in each dose-interval group
Timeframe: 14 days after the last dose of the study agent