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02 September 2010
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| [ Print-friendly version ] |
| Immune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in the Sultanate of Oman |
| ISRCTN | ISRCTN17418767 |
| ClinicalTrials.gov identifier | |
| 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? |
| 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 |
| 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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