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

01 Apr 2016

The date of last modification

Jan 29, 2019



Application Summary


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


Trial Details


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

  1. Children aged 10-12 years
  2. Residence in the selected areas of the Kalutara District
  3. Parent/Guardian provides consent for child’s participation

Exclusion criteria

  1. Contraindication for venipuncture
  2. Sick child requiring hospitalization for acute or chronic illness
  3. Diagnosis or suspicion of congenital immunodeficiency disorder in the subject or an immediate family member


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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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