Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000482864
Ethics application status
Not yet submitted
Date submitted
27/04/2012
Date registered
2/05/2012
Date last updated
2/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison trial of three needle-free devices for application of intradermal inactivated polio vaccine in young infants in Cuba
Scientific title
Comparison of immune response of fractional inactivated poliovirus vaccine (IPV) administered intradermally using different administration techniques in young infants in Camaguey, Cuba
Secondary ID [1] 280417 0
none
Universal Trial Number (UTN)
U1111-1130-3070
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poliomyelitis 286386 0
Condition category
Condition code
Infection 286632 286632 0 0
Other infectious diseases
Public Health 286633 286633 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intradermal administration of single fractional dose of inactivated polio vaccine via BCG needle or one of three different needle-free devices.

There are 4 interventional arms (in each arm one IPV dose is administered):

1 - fIPV intradermally through BCG syringe (fractional dose - 0.1ml)
2 - fIPV Device A (Biojector 2000, dose 0.1 ml)
3 - fIPV Device B (Bioject ID Pen, dose 0.1 ml)
4 - fIPV Device C (Pharmajet, dose 0.1 ml)
Intervention code [1] 284767 0
Prevention
Comparator / control treatment
Intramuscular administration of one full dose of inactivated polio vaccine (0.5 ml) using standard auto-destruct needle and syringe.
Control group
Active

Outcomes
Primary outcome [1] 287034 0
The primary endpoint is seroconversion or boost of polio antibodies by neutralization assay on day 28 compared to day 0
Timepoint [1] 287034 0
Day 28 from enrollment
Secondary outcome [1] 297253 0
Seroconversion or boost of antibodies by neutralization assay on days 3 and 7.
Timepoint [1] 297253 0
Day 3 and Day 7 from enrollment
Secondary outcome [2] 297265 0
Assessment of priming immune response after the first dose of IPV by neutralization assay.
Timepoint [2] 297265 0
Day 7 from enrollment

Eligibility
Key inclusion criteria
Healthy infants born between July 1 and December 31, 2011 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers with documented history of receiving two doses of OPV through NIDs in 2012.
Minimum age
9 Months
Maximum age
16 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infants <3 percentile for height and weight, residence outside the catchment’s area, or families expecting to move away during the study period, will be excluded. A diagnosis, suspicion or treatment of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study. Infants of mother age below legal age (<18 years) or with mentally incapacity will not be eligible to participate.

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 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 4284 0
Cuba
State/province [1] 4284 0

Funding & Sponsors
Funding source category [1] 285172 0
Other
Name [1] 285172 0
World Health Organization
Country [1] 285172 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization
Address
Avenue Appia 20
CH-1211 Geneva 27
Country
Switzerland
Secondary sponsor category [1] 284038 0
None
Name [1] 284038 0
Address [1] 284038 0
Country [1] 284038 0
Other collaborator category [1] 260776 0
Other Collaborative groups
Name [1] 260776 0
Instituto Pedro Kouri (IPK), Habana, Cuba
Address [1] 260776 0
Marianao 13, Ciudad de La Habana
Country [1] 260776 0
Cuba

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287179 0
ERC of the World Health Organization
Ethics committee address [1] 287179 0
Avenue Appia 20
CH-1211 Geneva 27
Ethics committee country [1] 287179 0
Switzerland
Date submitted for ethics approval [1] 287179 0
16/04/2012
Approval date [1] 287179 0
Ethics approval number [1] 287179 0
RPC506

Summary
Brief summary
This trial will inform on polio eradication prerequisite regarding implementation of IPV requirements in countries that retain poliovirus in laboratories or in production as well as on the performance and usability of three different needle-free devices to deliver fractional dose IPV (affordable IPV) in routine immunization programs as well as during vaccination campaigns.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34120 0
Address 34120 0
Country 34120 0
Phone 34120 0
Fax 34120 0
Email 34120 0
Contact person for public queries
Name 17367 0
Ondrej Mach
Address 17367 0
WHO
Avenue Appia 20
CH-1211 Geneva 27
Country 17367 0
Switzerland
Phone 17367 0
+41227911863
Fax 17367 0
Email 17367 0
macho@who.int
Contact person for scientific queries
Name 8295 0
Ondrej Mach
Address 8295 0
WHO
Avenue Appia 20
CH-1211 Geneva 27
Country 8295 0
Switzerland
Phone 8295 0
+41227911863
Fax 8295 0
Email 8295 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.