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ISRCTN
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ISRCTN76316509
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ClinicalTrials.gov identifier
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Public title
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Comparative evaluation of immunogenicity of monovalent type 1 oral poliovirus vaccine (mOPV1) versus trivalent OPV (tOPV): a randomised double-blind trial set in Egypt
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Scientific title
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Acronym
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N/A
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Serial number at source
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RPC 127
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Study hypothesis
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One dose of monovalent oral poliovirus vaccine induces higher levels of seroconversion against poliovirus type 1 when compared to trivalent oral poliovirus vaccine.
Please note that as of 18/10/2007 the anticipated start and end dates of this trial were modified, the initial trial dates were as follows:
Anticipated start date: 15/07/2005
Anticipated end date: 31/07/2006
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Lay summary
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Ethics approval
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Ethics approval received on the 28th June 2005.
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Study design
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Clinical trial, evaluation based, randomised double blind trial
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Countries of recruitment
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Egypt
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Disease/condition/study domain
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Polio
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Participants - inclusion criteria
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1. Infants born healthy (greater than or equal to 2.75 kg, apgar score greater than or equal to 9 at five minutes) at the study site(s) (large maternity hospitals)
2. Residing within a relatively short and easily accessible distance (less than 30 km) in the same governorate as the study site
3. Not planning to travel away during entire the study period (birth to two months)
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Participants - exclusion criteria
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1. High-risk newborns will be excluded
2. Newborns requiring hospitalisation
3. Birth weight below 2.75 kg
4. Apgar score less than 9 at five minutes
5. Residence greater than 30 km from study site (or residing in another governorate)
6. Family is planning to be absent during the 60-day study period
7. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study
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Anticipated start date
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15/07/2005
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Anticipated end date
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31/07/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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600
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Interventions
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One dose of monovalent oral poliovirus vaccine compared to trivalent oral poliovirus vaccine.
Measurements:
1. Cord blood will be collected immediately after birth
2. 30 days after birth, second sample of blood collected by heel stick method and a stool sample taken
3. Four additional stool samples collected on a weekly basis at 7, 14, 21, and 28 days after birth
4. 60 days after birth, third sample of blood collected by heel stick method
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Primary outcome measure(s)
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To demonstrate the superiority of one dose of mOPV1 compared with tOPV by assessing:
1. Humoral Immunity - one dose of mOPV1 induces significantly higher levels of seroconversion against poliovirus type 1 than does one dose of tOPV
2. Mucosal Immunity - one dose of mOPV1 significantly reduces excretion of poliovirus type 1 after a mOVP1 challenge than following one dose of tOPV
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Secondary outcome measure(s)
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The secondary endpoint is prevalence of excretion of poliovirus type 1 in stool specimens 7 days post-challenge with mOPV1 at age 30 days + 7 days. Additional endpoints will be prevalence of excretion in 4 weeks after mOPV1 challenge by vaccination group; and seroconversion at 60 days after 2 doses of mOPV1 (no control available).
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Sources of funding
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Gates Foundation (USA)
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Trial website
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Publications
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Results http://www.ncbi.nlm.nih.gov/pubmed/18923170
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Contact name
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Ms
Anna-Lea Jenny
Kahn
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Address
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World Health Organization
20, Avenue Appia
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City/town
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Geneva-27
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Zip/Postcode
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CH 1211
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Country
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Switzerland
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Tel
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+41 (0)22 791 3135
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Email
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kahna@who.int
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Sponsor
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World Health Organization (WHO) (Switzerland)
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Address
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20, Avenue Appia
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City/town
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Geneva-27
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Zip/Postcode
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CH 1211
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Country
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Switzerland
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Tel
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+41 (0)22 791 3135
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Email
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sutterr@who.int
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Sponsor website:
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http://www.who.int
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Date applied
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12/09/2005
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Last edited
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17/10/2008
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Date ISRCTN assigned
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01/02/2006
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