Status:
COMPLETED
Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.
Conditions:
Cholera
Eligibility:
All Genders
1-45 years
Phase:
PHASE1
PHASE2
Brief Summary
Cholera, a rapidly dehydrating watery diarrheal disease transmitted through water or food contaminated with the bacterium, Vibrio cholerae, is a major cause of morbidity and mortality in low income co...
Detailed Description
Background : Cholera continues to be a major cause of morbidity and mortality in low income countries including Bangladesh. It is estimated that there are at least 300,000 severe cases and over 4,500 ...
Eligibility Criteria
Inclusion
- Age: 1years to less than 5 years for the younger children group; 5- less than18 years for older children and adolescent group and 18- 45 years (inclusive) for the adult group.
- Sex: Male, Female, Transgender.
- Consent: Informed consent from study participants and guardian in case of children along with assent in children 11-17 years (inclusive) of age.
- Apparently healthy.
Exclusion
- Suffering from diarrhoea or abdominal pain or vomiting in the past 24 hours or diarrhoea lasting for more than 2 weeks in the past 6 months
- History of taking oral cholera vaccine.
- History of taking any other live or killed enteric vaccine in the last 8 weeks.
- History of anaphylaxis or serious vaccine reaction.
- Currently use of any immunosuppressive or immune-modifying drugs.
- Receipt of blood or blood products or parenteral immunoglobulin preparation in the past 3 months.
- Currently on antimicrobial therapy (taking antibiotics within 24 hours during screening and vaccination).
- Severe malnutrition defined as wt-for-ht z-score \<-3.0 with or without oedema.
- For married females pregnancy or plans to become pregnant during the study period (as determined by verbal screening) will be excluded. In addition, pregnancy test will be done by pregnancy strip test before each day of vaccination (Day 0 and day 14) for married female.
- Culture positive V. cholerae, ETEC, Salmonella and Shigella in stool.
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT02823899
Start Date
July 1 2016
End Date
November 1 2017
Last Update
November 2 2018
Active Locations (1)
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1
International Centre for Diarrhoeal disease Research,Bangladesh
Dhaka, Bangladesh, 1212