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Trial registered on ANZCTR


Registration number
ACTRN12617001525370
Ethics application status
Approved
Date submitted
24/08/2017
Date registered
3/11/2017
Date last updated
3/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trial to assess whether it is safe and efficient to vaccinate children with lower dose of Inactivated Poliovirus Vaccine (IPV) , Cuba 2017
Scientific title
Comparison of Immunogenicity of full dose Inactivated Poliovirus Vaccine (IPV) and fractional dose IPV administered to infants intramuscularly or intradermally, Cuba 2017
Secondary ID [1] 292726 0
none
Universal Trial Number (UTN)
U1111-1201-2378
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polio 304490 0
Condition category
Condition code
Infection 303828 303828 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: intramuscular (i.m.) administration of fractional dose of Inactivated Poliovirus Vaccine (fIPV) - 0.1ml [one dose at 4 months of age and one dose at 8 months of age]
Arm B: im fIPV - 0.2ml [one dose at 4 months of age and one dose at 8 months of age]
Arm C:: intradermal (i.d.) fIPV - 0.1ml [one dose at 4 months of age and one dose at 8 months of age]


Intervention code [1] 298969 0
Prevention
Comparator / control treatment
Arm D: One Full dose of intramuscular Inactivated Poliovirus Vaccine - 0.5ml
Control group
Dose comparison

Outcomes
Primary outcome [1] 303189 0
% difference in immune response between study arms as assessed by difference in anti-polio neutralizing antibodies in sera collected on first and last visit
Timepoint [1] 303189 0
28 days post vaccination
Secondary outcome [1] 338187 0
% difference in anamnestic response between study arms as assessed by difference in anti-polio neutralizing antibodies in sera collected on day of second vaccination and one week post second vaccination
Timepoint [1] 338187 0
1 week post immunization

Eligibility
Key inclusion criteria
Healthy infants born between April 15 and May 31, 2017 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers in Camaguey, Cuba
Minimum age
4 Months
Maximum age
4 Months
Gender
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 child 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
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] 9169 0
Cuba
State/province [1] 9169 0
Camaguey

Funding & Sponsors
Funding source category [1] 297365 0
Other Collaborative groups
Name [1] 297365 0
WHO
Address [1] 297365 0
Polio Department
World Health Organization
Avenue Appia 20
CH-1211 Genève 27 Suisse
Country [1] 297365 0
Switzerland
Primary sponsor type
Other Collaborative groups
Name
WHO
Address
Polio Department
World Health Organization
Avenue Appia 20
CH-1211 Genève 27 Suisse
Country
Switzerland
Secondary sponsor category [1] 296342 0
None
Name [1] 296342 0
Address [1] 296342 0
Country [1] 296342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298467 0
WHO ERC
Ethics committee address [1] 298467 0
Polio Department
World Health Organization
Avenue Appia 20
CH-1211 Genève 27 Suisse
Ethics committee country [1] 298467 0
Switzerland
Date submitted for ethics approval [1] 298467 0
Approval date [1] 298467 0
01/08/2017
Ethics approval number [1] 298467 0

Summary
Brief summary
Inactivated poliovirus vaccine (IPV) has been introduced globally, however, in 2016 shortages of IPV supply caused stock-outs and put strain on IPV use for routine immunizations as well as for poliovirus outbreak response; this shortage is going to last until 2018 if not longer. Administration of 1/5th IPV dose intradermally (fractional IPV or fIPV) has been proved to be safe and provides similar immune response as full dose IPV administered intramuscular, however, fIPV administered with BCG needle and syringe (BCG NS) intradermally is technically difficult and many countries are hesitant to adopt fIPV in their routine immunization schedules because of the additional needs for training of health staff.
fIPV administered intramuscularly has been less examined; the few documented uses of intramuscular fIPV suggest no safety concerns, however, it is unclear whether desired immunogenicity could be achieved.
In this study we will compare immunogenicity achieved after two doses of full dose IPV or fIPV administered at the age of 4 and 8 months to poliovirus naive children in Cuba. We will assess two volumes of fIPV doses: 1/5th and 2/5th of full dose (0.1 ml and 0.2 ml).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77174 0
Dr Sonia Resik
Address 77174 0
Instituto de Medicina Tropical Pedro Kouri
Apdo. Postal 601, Marianao 13, La Habana, Cuba
Country 77174 0
Cuba
Phone 77174 0
+537 202-0633
Fax 77174 0
Email 77174 0
ciipk@ipk.sld.cu
Contact person for public queries
Name 77175 0
Dr Ondrej Mach
Address 77175 0
Polio Department
World Health Organization
Avenue Appia 20
CH-1211 Genève 27 Suisse
Country 77175 0
Switzerland
Phone 77175 0
+41227911863
Fax 77175 0
Email 77175 0
macho@who.int
Contact person for scientific queries
Name 77176 0
Dr Ondrej Mach
Address 77176 0
Polio Department
World Health Organization
Avenue Appia 20
CH-1211 Genève 27 Suisse
Country 77176 0
Switzerland
Phone 77176 0
+41227911863
Fax 77176 0
Email 77176 0
macho@who.int

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