Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000124437p
Ethics application status
Submitted, not yet approved
Date submitted
3/12/2015
Date registered
3/02/2016
Date last updated
3/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of boosting of mucosal immunity after full and fractional dose of inactivated poliovirus vaccine, clinical trial in children in Sri Lanka, 2016
Scientific title
Comparison of boosting of mucosal immunity after full and fractional dose of inactivated poliovirus vaccine, a randomized clinical trial in 300 children aged 10-12 years of age living in Kalutara district of Sri Lanka, 2016
Secondary ID [1] 288059 0
nil
Universal Trial Number (UTN)
U1111-1177-2137
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poliomyelitis 296928 0
Condition category
Condition code
Infection 297169 297169 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Full one dose (0.5 ml) of inactivated poliovirus vaccine administered intramuscularly
or
Fractional one dose (0.1 ml) of inactivated poliovirus vaccine administered intradermally
Intervention code [1] 293380 0
Prevention
Comparator / control treatment
no vaccine administered in the control group
Control group
Active

Outcomes
Primary outcome [1] 296776 0
Difference in proportion of children excreting vaccine polioviruses (by serotype) between arms among those who serologically respond to IPV measured by isolation of poliovirus in stool
Timepoint [1] 296776 0
7 days after administration of live oral poliovirus vaccine
Secondary outcome [1] 319326 0
Difference in duration of poliovirus excretion between arms measured by isolation of poliovirus in stool
Timepoint [1] 319326 0
42 days after challenge with oral poliovirus vaccine

Eligibility
Key inclusion criteria
Any child 10-12 years of age residing in the determined area of Kalutara
Parent/Guardian provides consent for child’s participation, including vaccination with IPV/OPV and blood and stool sample collections
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindication for venepuncture
Sick child requiring hospitalization for acute or chronic condition
Diagnosis or suspicion of congenital immunodeficiency disorder in the subject or an immediate family member

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 7392 0
Sri Lanka
State/province [1] 7392 0

Funding & Sponsors
Funding source category [1] 292498 0
Other
Name [1] 292498 0
World Health Organisation
Country [1] 292498 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization
Address
Avenue Appia 20
CH-1211 Geneva 27 Switzerland
Country
Switzerland
Secondary sponsor category [1] 291207 0
None
Name [1] 291207 0
none
Address [1] 291207 0
none
Country [1] 291207 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293964 0
World Health Organisation
Ethics committee address [1] 293964 0
Avenue Appia 20
CH-1211 Geneva 27 Suisse
Ethics committee country [1] 293964 0
Switzerland
Date submitted for ethics approval [1] 293964 0
01/12/2015
Approval date [1] 293964 0
Ethics approval number [1] 293964 0

Summary
Brief summary
This study will evaluate the effect of fIPV on boosting mucosal immunity against polioviruses in Sri Lanka, a country with high routine immunization coverage with OPV and IPV introduced in its routine immunization schedule. It will enable decision makers in Sri Lanka as well as in other countries in similar situation, to evaluate risks and benefits of fIPV use for OBR in case of cVDPV2 outbreak following the tOPV to bOPV switch.

After April 2016, no country will be allowed to use tOPV therefore this is a last chance to conduct this type of a study and all study procedures must be completed by the end of April 2016.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61958 0
Dr Paba Palihawadana
Address 61958 0
Epidemiology Unit , Ministry of Health,Sri Lanka.
231, De Saram Road, Colombo 10
Country 61958 0
Sri Lanka
Phone 61958 0
+94-112 695 112
Fax 61958 0
Email 61958 0
paba@health.gov.lk
Contact person for public queries
Name 61959 0
Dr Ondrej Mach
Address 61959 0
World Health Organization
Avenue Appia 20
CH-1211 Geneva 27 Suisse
Country 61959 0
Switzerland
Phone 61959 0
+41227911863
Fax 61959 0
Email 61959 0
macho@who.int
Contact person for scientific queries
Name 61960 0
Dr ondrej mach
Address 61960 0
World Health Organization
Avenue Appia 20
CH-1211 Geneva 27 Suisse
Country 61960 0
Switzerland
Phone 61960 0
+41227911863
Fax 61960 0
Email 61960 0
macho@who.int

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.