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Immune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in the Sultanate of Oman
ISRCTN ISRCTN17418767
DOI 10.1186/ISRCTN17418767
ClinicalTrials.gov identifier
EudraCT number
Public title Immune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in the Sultanate of Oman
Scientific title
Acronym N/A
Serial number at source RPC189
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 2, 4, and 6 months?
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. Is resistance to excretion of poliovirus type 1 (an indication of mucosal immunity) following a challenge dose with monovalent type 1 Oral Poliovirus Vaccine (mOPV1) similar among the two study groups?
Lay summary
Ethics approval Ethics approval received from:
1. World Health Organization (WHO) Research Ethics Review Committee on the 29th January 2007 (ref: RPC189)
2. Ethical Review Committee of the Ministry of Health, Muscat, Oman on the 30th August 2006 (ref: 502)
Study design Randomised controlled clinical trial
Countries of recruitment Oman
Disease/condition/study domain Poliomyelitis vaccination
Participants - inclusion criteria 1. Healthy Omani newborns (greater than 2.5 kg, apgar score greater than 9 at five minutes)
2. Living within the catchment area of the participating study site
3. Newborns delivered by caesarean section
Participants - 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 at five minutes
4. Non-Omani
5. Residence outside the catchment area, or families expecting to move away during the study period
6. 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
Anticipated start date 15/02/2007
Anticipated end date 30/10/2007
Status of trial Completed
Patient information material
Target number of participants 400
Interventions 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 Ali Jaffer Mohammed
P.O. Box 393
Muscat 113
Oman
Tel: +968 (0)600808
Fax: +968 (0)696099
Email: alijamoh@omantel.net.om
Primary outcome measure(s) Seroconversion after three doses of IPV (fractional or full doses).
Secondary outcome measure(s) Seroconversion after each dose of vaccine.
Sources of funding World Health Organization (WHO)/Polio Eradication Initiative (POL) (Switzerland)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20573923
Contact name Dr  Pradeep  Malankar
  Address Technical Officer
World Health Organization
20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 (0)22 791 1863
  Fax +41 (0)22 791 1571
  Email malankarp@who.int
Sponsor World Health Organization (WHO) (Switzerland)
  Address 20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Sponsor website: http://www.polioeradication.org/content/fixed/opvcessation/opvcessation.asp
Date applied 14/08/2007
Last edited 25/06/2010
Date ISRCTN assigned 15/08/2007
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