ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

none

Universal Trial Number (UTN)

U1111-1201-2378

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

polio

Condition category

Condition code

Infection

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]

Prevention

Comparator / control treatment

Arm D: One Full dose of intramuscular Inactivated Poliovirus Vaccine - 0.5ml

Control group

Dose comparison

Outcomes

Primary outcome [1]

% 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]

28 days post vaccination

Secondary outcome [1]

% 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]

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

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

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

28/08/2017

Date of last participant enrolment

Anticipated

Actual

28/09/2017

Date of last data collection

Anticipated

28/01/2018

Actual

Sample size

Target

400

Accrual to date

Final

400

Recruitment outside Australia

Country [1]

Cuba

State/province [1]

Camaguey

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

WHO

Address [1]

Polio Department
World Health Organization
Avenue Appia 20
CH-1211 Genève 27 Suisse

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

WHO ERC

Ethics committee address [1]

Polio Department 
World Health Organization 
Avenue Appia 20 
CH-1211 Genève 27 Suisse

Ethics committee country [1]

Switzerland

Date submitted for ethics approval [1]

Approval date [1]

01/08/2017

Ethics approval number [1]

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

Dr Sonia Resik

Address

Instituto de Medicina Tropical Pedro Kouri
Apdo. Postal 601, Marianao 13, La Habana, Cuba

Country

Cuba

Phone

+537 202-0633

Fax

ciipk@ipk.sld.cu

Contact person for public queries

Name

Ondrej Mach

Address

Polio Department
World Health Organization
Avenue Appia 20
CH-1211 Genève 27 Suisse

Country

Switzerland

Phone

+41227911863

Fax

macho@who.int

Contact person for scientific queries

Name

Ondrej Mach

Address

Polio Department
World Health Organization
Avenue Appia 20
CH-1211 Genève 27 Suisse

Country

Switzerland

Phone

+41227911863

Fax

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

Source	Title	Year of Publication	DOI
Embase	Immunogenicity of Intramuscular Fractional Dose of Inactivated Poliovirus Vaccine.	2020	https://dx.doi.org/10.1093/infdis/jiz323

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically