Condition category
Infections and Infestations
Date applied
14/08/2007
Date assigned
15/08/2007
Last edited
11/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna-Lea Kahn

ORCID ID

Contact details

Technical Officer
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3135
kahna@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC171

Study information

Scientific title

Acronym

Study hypothesis

1. Does a schedule of three fractional 0.1 ml IPV doses administered intradermally (intervention) provide comparable seroconversion and titre with a three-dose schedule of full 0.5 ml IPV doses (control) administered intramuscularly at 6, 10, and 14 weeks?
2. What is the contribution to seroconversion and titre in each group after the first, second and third dose of study vaccines?
3. What is the influence of maternally-derived antibodies on seroconversion and titre?
4. Does each study arm have comparable adverse events - systemic and local (the intervention group receives fractional doses by needle-free device, while the control group receives full doses by intramuscular injection by needle and syringe)?
5. Do mothers whose study infants were vaccinated by needle-free device (study) and needle and syringe (routine program) express a preference for route for administration after the third vaccination?

Ethics approval

Ethics approval from:
1. World Health Organization (WHO) Research Ethics Review Committee on the 11th September 2006 (ref: RPC171)
2. Medical ethics committee of the Tropical Medicine Institute (Instituto de Medicina Tropical Pedro Kouri [IPK]) on the 17th August 2006

Study design

Randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Poliomyelitis vaccination

Intervention

Patients will be randomised between:
1. A fractional dose of IPV (0.1 ml or 1/5 of a dose) administered intradermally by needle-free device - potency of IPV is 40-8-32-D antigen units
2. A full dose of IPV (0.5 ml) administered intramuscularly by needle and syringe - potency of IPV is 40-8-32-D antigen units

Principal Investigator:
Dr Pedro Mas Lago
c/o Instituto de Medicina Tropical Pedro Kouri (IPK)
Ministerio de Salud Publica
P.O. Box 601
Havana, Mariana 13
Cuba
Tel: +53 (0)7 202 0430
Fax: +53 (0)7 204 6051
Email: pmasl@ipk.sld.cu

Intervention type

Drug

Phase

Not Specified

Drug names

Inactivated Poliovirus Vaccine (IPV)

Primary outcome measures

Seroconversion by neutralisation assay between birth and 18 weeks.

Secondary outcome measures

Seroconversion by neutralisation assay after each dose of study vaccines.

Overall trial start date

15/09/2006

Overall trial end date

30/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy newborns (greater than 2.5 kg, apgar score greater than 9 at five minutes)
2. Living within the catchment area of the participating polyclinics
3. Newborns delivered by caesarian section

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Newborns requiring hospitalisation (except if in hospital because of maternal admission)
2. Birth weight below 2.5 kg
3. Apgar score less than 9
4. Residence outside the catchment area, or families expecting to move away during the study period
5. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will also render the newborn ineligible for the study

Recruitment start date

15/09/2006

Recruitment end date

30/04/2007

Locations

Countries of recruitment

Cuba

Trial participating centre

Technical Officer
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

World Health Organization (WHO) (Switzerland)

Sponsor details

20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Sponsor type

Research organisation

Website

http://www.polioeradication.org/content/fixed/opvcessation/opvcessation.asp

Funders

Funder type

Research organisation

Funder name

World Health Organization (WHO)/Polio Eradication Initiative (POL) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes