Immune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in Cuba
ISRCTN | ISRCTN19673867 |
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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
Scientific
Technical Officer
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Phone | +41 (0)22 791 3135 |
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kahna@who.int |
Study information
Study design | Randomised controlled clinical trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Immune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in Cuba |
Study objectives | 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(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) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Inactivated Poliovirus Vaccine (IPV) |
Primary outcome measure | Seroconversion by neutralisation assay between birth and 18 weeks. |
Secondary outcome measures | Seroconversion by neutralisation assay after each dose of study vaccines. |
Overall study start date | 15/09/2006 |
Completion date | 30/04/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | 400 |
Total final enrolment | 320 |
Key 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 |
Key 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 |
Date of first enrolment | 15/09/2006 |
Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- Cuba
- Switzerland
Study participating centre
Technical Officer
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Website | http://www.polioeradication.org/content/fixed/opvcessation/opvcessation.asp |
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https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO)/Polio Eradication Initiative (POL) (Switzerland)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.