Home » Trials » SLCTR/2016/010
Inactivated Polio Vaccine (IPV) Mucosal Immunity Boosting Trial in Kalutara District, Sri Lanka 2016
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SLCTR Registration Number
SLCTR/2016/010
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Inactivated Polio Vaccine (IPV) Mucosal Immunity Boosting Trial in Kalutara District, Sri Lanka 2016
Public Title of Trial
Inactivated Polio Vaccine (IPV) Mucosal Immunity Boosting Trial in Kalutara District, Sri Lanka 2016
Disease or Health Condition(s) Studied
Polio virus immunity
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1177-2137
Any other number(s) assigned to the trial and issuing authority
SLMA-ERC no.015-042
What is the research question being addressed?
What is the difference in poliovirus mucosal immunity among children previously immunized with oral polio vaccine (OPV) who receive one full dose of inactivated polio vaccine (IPV) compared to those who receive a fractional dose of IPV or no IPV?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Dose comparison
Assignment
Parallel
Purpose
Basic science
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out at field settings, in 3 MOH areas in the Kalutara district. Participants meeting inclusion/exclusion criteria will be allocated into 3 arms using block randomization
Arm 1 will receive a single full dose of IPV Arm 2 will receive a fractional dose of IPV (1/5th of the standard dose) Arm 3 will not receive IPV
At 30 days, all participants will be given a standard dose of OPV (OPV challenge)
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Polio immunity as determined by IgG antibody levels (blood) |
[ IgG antibodies in blood: day 0 and day 30 following IPV ] |
|
2.
Polio virus excretion rates (stools) |
[ Polio virus excretion in stools: day 30 following IPV as a baseline, and then day 3, day 7 and day 14 following OPV ] |
|
3.
Duration of polio virus excretion (stools) |
[] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
300 (100 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2016-04-18
Anticipated end date
2016-05-30
Date of first enrollment
2016-04-02
Date of study completion
Recruitment status
Recruiting
Funding source
World Health Organisation
Regulatory approvals
Status
Approved
Date of Approval
2016-05-10
Approval number
03/2016
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Medical Research Institute, Ministry of Health |
| Institutional Address: | P.O. Box 527, Dr Danister De Silva Mawatha (Baseline Road), Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2693532 (Extension: 353) |
| Email: | erc_mri2016@hotmail.com |
Contact person for Scientific Queries/Principal Investigator
Deepa Gamage
Consultant Epidemiologist
Epidemiology Unit, No:231, De Saram Place, Colombo 10,
Sri Lanka
Tel: 0112695112
Mob: 0777295158
Fax: 0112696583
deepagamage@gmail.com
Contact Person for Public Queries
Deepa Gamage
Consultant Epidemiologist
Epidemiology Unit, No:231, De Saram Place, Colombo 10,
Sri Lanka
Tel: 0112695112
Mob: 0777295158
Fax: 0112696583
deepagamage@gmail.com
Primary study sponsor/organization
World Health Organization Head Quarters
No. 20, Avenue Appia-CH-1211
Geneva 27,
Switzerland
Tel: +41 22 7912111
Fax :+41227913111
macho@who.int, sutterr@who.int
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
