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Trial registered on ANZCTR


Registration number
ACTRN12615000305527
Ethics application status
Approved
Date submitted
23/01/2015
Date registered
1/04/2015
Date last updated
7/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of immune response of fractional doses, administered intradermally vs. full doses administered intramuscularly of inactivated poliovirus vaccine (IPV) in male adults in Camaguey, Cuba.
Scientific title
Comparison of immune response of fractional doses, administered intradermally vs. full doses administered intramuscularly of inactivated poliovirus vaccine (IPV) in male adults in Camaguey, Cuba.
Secondary ID [1] 285984 0
nil
Universal Trial Number (UTN)
U1111-1166-1588
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poliomyelitis 293924 0
Condition category
Condition code
Infection 294228 294228 0 0
Other infectious diseases
Public Health 294229 294229 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will receive two doses of intradermal injection of Salk IPV (20:32:64 DU/dose) 0.1 ml, 1 month apart
Intervention code [1] 290959 0
Prevention
Comparator / control treatment
Controls will recieve two doses of Salk IPV (20:32:64 DU/dose) 0.5 ml intramuscularly, 1 month apart
Control group
Active

Outcomes
Primary outcome [1] 294032 0
The primary endpoint is a boosting immune response, defined as the proportion (%) of subjects with a change from seronegative (reciprocal titer of less than 1:8 dilution) to seropositive after vaccine administration or an increase of four times or more in reciprocal titer for seropositive subjects (those with baseline reciprocal titer greater than 1:8)
Timepoint [1] 294032 0
At day 0 (baseline; visit 1), day 7 (after single dose; visit 2), day 28 (after single dose; visit 3) and day 56 (after two doses; visit 4)
Secondary outcome [1] 312367 0
The safety will be assessed by the number and intensity of local (e.g. redness, swelling ,infection) and systemic adverse reactions (e.g. fever)
Timepoint [1] 312367 0
Subjects will be observed during the first 60 minutes after vaccination in order to record the occurrence of acute reactions.
A diary will be given to each subject for reporting of adverse events in the first seven days after vaccination. Follow-up is done at 24 hours, 48 hours, 72 hours, and 7 days after vaccination

Eligibility
Key inclusion criteria
Subjects have to fulfill all of the following criteria:
*Males age 18 to 30, inclusive at the time of enrollment; and
*in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator; and
*must have received polio vaccinations with at least one dose of OPV according to the Cuban National Immunization Program as a child; and
*willing to sign an informed consent form.
Minimum age
18 Years
Maximum age
30 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria for vaccination are
* IPV or OPV booster dose after the age of 12 years; or
* Known or suspected exposure to wild poliovirus
* known or suspected allergy against any of the vaccine components; or
* history of unusual or severe reactions to any previous vaccination; or
* known or suspected disease or use of medication that may influence the immune system; or
* known or suspected immune deficiency, and/or known HIV infection; or
* systemic treatment with corticosteroids or immunosuppressant within one month before screening or during the study; or
* administration of plasma (including immunoglobulins) or blood products three months prior to the study during the study; or
* blood donation within one month before screening; or
* any vaccination within three months before screening and during the study until the last visit; or
* history of any neurological disorder including epilepsy or febrile seizures; or
*evidence of excessive alcohol use or drug use; or
*any infectious disease; or
*participation in another clinical trial within three months before enrollment.
*Bleeding disorders or the usage of anticoagulants.

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
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6595 0
Cuba
State/province [1] 6595 0
Camaguey

Funding & Sponsors
Funding source category [1] 290571 0
Other
Name [1] 290571 0
World Health Organization
Address [1] 290571 0
Avenue Appia 20
Geneva
CH-1211
Country [1] 290571 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization
Address
Avenue Appia 20
Geneva
CH-1211
Country
Switzerland
Secondary sponsor category [1] 289260 0
None
Name [1] 289260 0
Address [1] 289260 0
Country [1] 289260 0
Other collaborator category [1] 278296 0
Other Collaborative groups
Name [1] 278296 0
Instituto Pedro Kouri (IPK)
Address [1] 278296 0
Marianao 13, Ciudad de La Habana
Country [1] 278296 0
Cuba
Other collaborator category [2] 278298 0
Other Collaborative groups
Name [2] 278298 0
Provincial Center for Health, Epidemiology and Microbiology (CPHEM), Camaguey
Address [2] 278298 0
Cisneros 203, Camaguey
Country [2] 278298 0
Cuba

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292211 0
WHO Research Ethics Review Committee (WHO ERC)
Ethics committee address [1] 292211 0
Avenue Appia, 20
CH-1211 Geneva 27
Ethics committee country [1] 292211 0
Switzerland
Date submitted for ethics approval [1] 292211 0
29/11/2013
Approval date [1] 292211 0
07/04/2014
Ethics approval number [1] 292211 0
RPC635
Ethics committee name [2] 292212 0
IPK Ethics Committee
Ethics committee address [2] 292212 0
P.O. Box: 601 Marianao 13
Habana
Ethics committee country [2] 292212 0
Cuba
Date submitted for ethics approval [2] 292212 0
28/11/2013
Approval date [2] 292212 0
14/01/2014
Ethics approval number [2] 292212 0
Ethics committee name [3] 292223 0
Provincial Center for Health, Epidemiology and Microbiology (CPHEM), Camaguey IRB
Ethics committee address [3] 292223 0
Cisneros 203, Camaguey
Ethics committee country [3] 292223 0
Cuba
Date submitted for ethics approval [3] 292223 0
18/11/2014
Approval date [3] 292223 0
20/11/2014
Ethics approval number [3] 292223 0

Summary
Brief summary
To demonstrate the non-inferiority of boosting immune responses after administration of one and two intradermal IPV doses compared with one and two intramuscular IPV doses in healthy adults with history of vaccination with at least one dose of OPV.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54110 0
Dr Sonia Resik
Address 54110 0
Instituto de Medicina Tropical "Pedro Kourí" (IPK)
P.O. Box: 601 Marianao 13
Habana
Country 54110 0
Cuba
Phone 54110 0
+53 7 2553550
Fax 54110 0
Email 54110 0
sresik@ipk.sld.cu
Contact person for public queries
Name 54111 0
Dr Sonia Resik
Address 54111 0
Instituto de Medicina Tropical "Pedro Kouri" (IPK)
P.O. Box: 601 Marianao 13
Habana
Country 54111 0
Cuba
Phone 54111 0
+53 7 2553550
Fax 54111 0
Email 54111 0
sresik@ipk.sld.cu
Contact person for scientific queries
Name 54112 0
Dr Sonia Resik
Address 54112 0
Instituto de Medicina Tropical "Pedro Kouri" (IPK)
P.O. Box: 601 Marianao 13
Habana
Country 54112 0
Cuba
Phone 54112 0
+53 7 2553550
Fax 54112 0
Email 54112 0
sresik@ipk.sld.cu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary