Immune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in Cuba

ISRCTN ISRCTN19673867
DOI https://doi.org/10.1186/ISRCTN19673867
Secondary identifying numbers RPC171
Submission date
14/08/2007
Registration date
15/08/2007
Last edited
30/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anna-Lea Kahn
Scientific

Technical Officer
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Phone +41 (0)22 791 3135
Email kahna@who.int

Study information

Study designRandomised controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleImmune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in Cuba
Study objectives1. 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(s)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
Health condition(s) or problem(s) studiedPoliomyelitis vaccination
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Inactivated Poliovirus Vaccine (IPV)
Primary outcome measureSeroconversion by neutralisation assay between birth and 18 weeks.
Secondary outcome measuresSeroconversion by neutralisation assay after each dose of study vaccines.
Overall study start date15/09/2006
Completion date30/04/2007

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants400
Total final enrolment320
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment15/09/2006
Date of final enrolment30/04/2007

Locations

Countries of recruitment

  • Cuba
  • Switzerland

Study participating centre

Technical Officer
Geneva-27
CH-1211
Switzerland

Sponsor information

World Health Organization (WHO) (Switzerland)
Research organisation

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 31/01/2013 30/09/2021 Yes No

Editorial Notes

30/09/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.