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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN76316509 |
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Date of registration:
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01/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Date of first enrolment:
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15/07/2005 |
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Target sample size:
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600 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN76316509 |
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Study type:
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Interventional |
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Study design:
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Clinical trial, evaluation based, randomised double blind trial (Prevention)
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Phase:
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Anna-Lea Jenny
Kahn |
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Address:
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World Health Organization
20, Avenue Appia
CH 1211
Geneva-27
Switzerland |
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Telephone:
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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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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 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)
Exclusion criteria: 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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Polio
Infections and Infestations
Polio
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Intervention(s)
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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(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(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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Source(s) of Monetary Support
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Gates Foundation (USA)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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