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