|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 April 2021 |
|
Main ID: |
NCT03373669 |
|
Date of registration:
|
04/12/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine
|
|
Scientific title:
|
Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine |
|
Date of first enrolment:
|
November 16, 2017 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03373669 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Zambia
| | | | | | | |
|
Contacts
|
|
Name:
|
Amanda K Debes, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Johns Hopkins Bloomberg School of Public Health |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Age =1 year, stratified into different age groups
2. Living in the Waya Clinic Catchment Area
3. Good health condition, without clinically significant medical history (by participant
or guardian, in case of minor)
4. Not pregnant for female subjects.
5. Available to participate for the study duration, including all planned follow-up
visits for up to 9 months from screening.
6. Signed informed consent
Exclusion Criteria:
1. Presence of a significant medical or psychiatric condition (Examples include:
Diagnosis and treatment of tuberculosis (TB) or HIV; renal insufficiency; hepatic
disease; oral or parenteral medication known to affect the immune function, such as
corticosteroids, other immunosuppressant drugs; or behavioural or memory issues)
2. Ever having received oral cholera vaccine.
3. Receipt of an investigational product (within 30 days before vaccination).
4. History of diarrhoea in 7 days prior to first dose of vaccine (defined as =3 unformed
loose stools in 24 hours).
5. History of chronic diarrhea (lasting for more than 2 weeks in the past 6 months)
6. Current use of laxatives, antacids, or other agents to lower stomach acidity?
7. Planning to become pregnant in the next 2 years.
Age minimum:
1 Year
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cholera
|
|
Vibrio Cholerae Infection
|
|
Intervention(s)
|
|
Biological: Oral Cholera Vaccine
|
|
Biological: Adjusted Dose Oral Cholera Vaccine
|
|
Primary Outcome(s)
|
|
Change in Vibriocidal GMT
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
IgG ELISA Antibody Response
[Time Frame: 2 weeks and 6 months]
|
|
IgA ELISA Antibody Response
[Time Frame: 2 weeks and 6 months]
|
|
Age specific vibriocidal response
[Time Frame: 2 weeks and 6 months]
|
|
Vibriocidal Antibody Response Rates
[Time Frame: 2 weeks and 6 months]
|
|
Secondary ID(s)
|
|
IRB00008066
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|