Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001046099
Ethics application status
Approved
Date submitted
19/05/2010
Date registered
30/11/2010
Date last updated
30/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immune response to two-dose fractional inactivated poliovirus vaccine administered at 4- and 8- month of age
Scientific title
Immune response and seroconversion in two-dose fractional inactivated poliovirus vaccine administered at 4 and 8 months of age
Secondary ID [1] 251812 0
RPC329
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poliomyelitis 257408 0
Condition category
Condition code
Public Health 257558 257558 0 0
Epidemiology
Infection 257594 257594 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two fractional 0.1 ml IPV doses administered intradermally at 4 and 8 month old infants
Intervention code [1] 256513 0
Prevention
Intervention code [2] 257670 0
Other interventions
Comparator / control treatment
Full 0.5 ml IPV doses administered intramuscularly at 4- and 8-month of age
Control group
Dose comparison

Outcomes
Primary outcome [1] 258469 0
Seroconversion by neutralization assay following 2 doses of IPV administered
Timepoint [1] 258469 0
9 months (using serum samples collected 4, 8 and 9 months of age)
Primary outcome [2] 258470 0
seroconversion after the first dose; and priming following a first dose; and seroconversion following a second dose
Timepoint [2] 258470 0
8 months (using serum samples collected at 4 and 8 months); at 8 months and 7 days (using serum samples collected at 8 and 8 months + 7 days); and 9 months (using serum samples collected at 8 and 9 months)
Primary outcome [3] 258471 0
The primary endpoint for the study addendum is decrease in excretion prevalence following received of trivalent oral poliovirus vaccine (tOPV) in the National Immunization Days (NIDs) in February and April 2010
Timepoint [3] 258471 0
Stool samples will be collected after the February and March OPV mass administration during NIDs
Secondary outcome [1] 264260 0
Increase in saliva secretary Immunoglobulin A (IgA), Immunoglobulin G (IgG), and Immunoglobulin M (IgM) in oral fluid samples collected after a dose of tOPV
Timepoint [1] 264260 0
First at 9 months, and then before and after mass campaign administration of OPV
Secondary outcome [2] 266465 0
Increase in saliva secretory IgA following administration of OPV in mass campaigns
Timepoint [2] 266465 0
First at 9 months, then before and after mass campaign administration of OPV

Eligibility
Key inclusion criteria
Healthy infants (greater than 3rd percentile for height and weight) at enrollment living within the catchment area of
the participating polyclinics.
Minimum age
4 Months
Maximum age
5 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infants less than 3 percentile for height and weight, residence outside the catchment 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)
Mothers or caretakers will be invited to participate when they present for the 2-month routine immunization visit. Infants are enrolled following the 2-month clinical assessment visit. Study envelopes will be used to determine which study vaccines a study participant will receive.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The use of random number generator (for randomization) will be used allocate study participants to a study arm, and its use will attempt to minimize/avoid bias.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomized, controlled trial of fractional (1/5 of a full dose) IPV given intradermally (intervention group) versus full-dose IPV given intramuscularly at age 4 and 8 months
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment outside Australia
Country [1] 2647 0
Cuba
State/province [1] 2647 0
camaguey

Funding & Sponsors
Funding source category [1] 257001 0
Other
Name [1] 257001 0
World Health Organization
Country [1] 257001 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization
Address
Avenue Appia 20
Geneva
CH-1211
Country
Switzerland
Secondary sponsor category [1] 256263 0
None
Name [1] 256263 0
Address [1] 256263 0
Country [1] 256263 0
Other collaborator category [1] 1277 0
Other Collaborative groups
Name [1] 1277 0
Instituto Pedro Kouri (IPK)
Address [1] 1277 0
Autopista Novia del Mediodia km 61/2 entre Autopista Nacional y Carretera Central. La Lisa, Ciudad Habana, Cuba.
Country [1] 1277 0
Cuba
Other collaborator category [2] 1278 0
Government body
Name [2] 1278 0
Ministry of Health
Address [2] 1278 0
National Device Registration Authority: CECEM: Calle 4 No. 455 altos entre 19 y 21. Vedado, Ciudad Habana, Cuba
Country [2] 1278 0
Cuba
Other collaborator category [3] 1279 0
Government body
Name [3] 1279 0
Provincial Health Authority
Address [3] 1279 0
General Gomez # 5 entre Avellaneda y Republica. Camaguey, Cuba
Country [3] 1279 0
Cuba
Other collaborator category [4] 1280 0
Government body
Name [4] 1280 0
Regulatory Authority (CECMED)
Address [4] 1280 0
National Regulatory Authority: CECMED: Calle 200 # 1706 entre 17 y 19. Reparto Siboney, Playa, Ciudad Habana, Cuba.
Country [4] 1280 0
Cuba
Other collaborator category [5] 1296 0
Other Collaborative groups
Name [5] 1296 0
World Health Organization
Address [5] 1296 0
Avenue Appia 20

Geneva CH-1211
Country [5] 1296 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259018 0
IPK Ethics Committee
Ethics committee address [1] 259018 0
P.O. Box: 601 Marianao 13
Habana
Ethics committee country [1] 259018 0
Cuba
Date submitted for ethics approval [1] 259018 0
Approval date [1] 259018 0
13/03/2009
Ethics approval number [1] 259018 0
Ethics committee name [2] 259019 0
WHO Research Ethics Review Committee
Ethics committee address [2] 259019 0
World Health Organization
20, Avenue Appia,
Geneva 1211
Ethics committee country [2] 259019 0
Switzerland
Date submitted for ethics approval [2] 259019 0
06/05/2009
Approval date [2] 259019 0
18/05/2009
Ethics approval number [2] 259019 0
RPC329

Summary
Brief summary
The purpose of this study is to test the efficacy of a two dose schedule using either fractional or full dose IPV with the ultimate purpose to find a way for developing countries to adopt more affordable IPV use strategies in the future. It is hypothesized the fractional dose arm will be non-inferior to the full dose arm.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31186 0
Address 31186 0
Country 31186 0
Phone 31186 0
Fax 31186 0
Email 31186 0
Contact person for public queries
Name 14433 0
Roland Sutter
Address 14433 0
World Health Organization
Avenue Appia 20
Geneva
Country 14433 0
Switzerland
Phone 14433 0
+41 22 79 14682
Fax 14433 0
Email 14433 0
[email protected]
Contact person for scientific queries
Name 5361 0
Roland Sutter
Address 5361 0
Avenue Appia 20
Geneva
CH-1211
Country 5361 0
Switzerland
Phone 5361 0
+41 22 79 14682
Fax 5361 0
Email 5361 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIPriming after a Fractional Dose of Inactivated Poliovirus Vaccine2013https://doi.org/10.1056/nejmoa1202541
N.B. These documents automatically identified may not have been verified by the study sponsor.