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Trial registered on ANZCTR


Registration number
ACTRN12616000169448
Ethics application status
Approved
Date submitted
4/12/2015
Date registered
10/02/2016
Date last updated
10/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Role of oral and inactivated poliovitus vaccines in inducing mucosal immunity - a trial in small children in Cuba
Scientific title
Comparison of mucosal immunity against polioviruses induced by inactivated poliovirus vaccine alone or in combination with bivalent oral poliovirus vaccine - a trial in small children in Cuba
Secondary ID [1] 288077 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poliomyelitis 296941 0
Condition category
Condition code
Infection 297187 297187 0 0
Other infectious diseases
Public Health 297470 297470 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IPV: one dose (0.5 ml) of Inactivated poliovirus vaccine administered intramuscularly; tOPV: one dose (2 drops) of trivalent oral poliovirus vaccine administered orally; bOPV: one dose (2 drops) of bivalent poliovirus vaccine administered orally; all vaccines administered on-site by study staff

All Arms: blood collection at enrollment, 30 and 60 days post enrollment; stool collection 30, 37, 44 and 51 days post enrollment

Arm 1: IPV at enrollment; tOPV 30 days post enrollment
Arm 2: IPV+bOPV at enrollment, tOPV 30 days post enrollment
Arm 3: no vaccine at enrollment, tOPV 30 days post enrollment
Intervention code [1] 293388 0
Prevention
Comparator / control treatment
Arm 3 is reference arm.
Control group
Active

Outcomes
Primary outcome [1] 296792 0
difference in poliovirus shedding in stool
Timepoint [1] 296792 0
7 days after tOPV dose
Secondary outcome [1] 319371 0
difference in dynamic of poliovirus shedding after tOPV dose assessed by virus isolation in stool on days 14, 21 and 42 after tOPV dose
Timepoint [1] 319371 0
14, 21 and 42 days after tOPV challenge

Eligibility
Key inclusion criteria
Healthy infants born between June 1 and August 31, 2015 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers will be eligible for enrollment to Arms 1 and 2.
Healthy infants born between November 1 and December 31, 2015 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers will be eligible for enrollment to Arm 3.
Minimum age
3 Months
Maximum age
7 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 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
Non-randomised 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] 7394 0
Cuba
State/province [1] 7394 0
Camaguey

Funding & Sponsors
Funding source category [1] 292507 0
Other
Name [1] 292507 0
WHO
Country [1] 292507 0
Switzerland
Primary sponsor type
Other
Name
WHO
Address
World Health Organization
Avenue Appia 20
CH-1211 Geneva 27 Suisse
Country
Switzerland
Secondary sponsor category [1] 291216 0
None
Name [1] 291216 0
Address [1] 291216 0
Country [1] 291216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293982 0
ERC Ministry of Health, Cuba
Ethics committee address [1] 293982 0
Ethics committee country [1] 293982 0
Cuba
Date submitted for ethics approval [1] 293982 0
07/12/2015
Approval date [1] 293982 0
08/01/2016
Ethics approval number [1] 293982 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61990 0
Dr Sonia Resik
Address 61990 0
Autopista Novia del Mediodia, KM 6 1/2 La Lisa, La Habana, CUBA
Country 61990 0
Cuba
Phone 61990 0
+53 72553550
Fax 61990 0
Email 61990 0
sresik@ipk.sld.cu
Contact person for public queries
Name 61991 0
Ondrej Mach
Address 61991 0
World Health Organization
Avenue Appia 20
CH-1211 Geneva 27 Suisse
Country 61991 0
Switzerland
Phone 61991 0
+41227911863
Fax 61991 0
Email 61991 0
macho@who.int
Contact person for scientific queries
Name 61992 0
ondrej mach
Address 61992 0
World Health Organization
Avenue Appia 20
CH-1211 Geneva 27 Suisse
Country 61992 0
Switzerland
Phone 61992 0
+41227911863
Fax 61992 0
Email 61992 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
SourceTitleYear of PublicationDOI
EmbaseDoes Simultaneous Administration of Bivalent (Types 1 and 3) Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine Induce Mucosal Cross-immunity to Poliovirus Type 2?.2018https://dx.doi.org/10.1093/cid/ciy604
N.B. These documents automatically identified may not have been verified by the study sponsor.