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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: |
ISRCTN88861431 |
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Date of registration:
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25/11/2005 |
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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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Study of safety and immunogenicity of Measles vaccine (Rouvax®) administered by transcutaneous route (France)
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Scientific title:
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Date of first enrolment:
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23/03/2004 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN88861431 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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France
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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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Martin
Friede |
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Address:
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20, Avenue Appia
CH 1211
Geneva-27
Switzerland |
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Telephone:
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+41 (0)22 791 4398 |
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Email:
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friedem@who.int |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Healthy adults between 18 and 22 years of age of haplotype HLA-A201 who have previously been immunised against measles and for whom the anti-measles antibodies are low
2. Female participants must be under contraception
Exclusion criteria: 1. Previous infection with measles
2. Contra-indications to the use of Rouvax® vaccine
3. Hypersensitivity to egg proteins
4. Human Immunodeficiency Virus (HIV) seropositive
5. Treatment with corticosteroids or immunosuppressors in 15 days prior to enrolment
6. Exposure of back-skin to sun in 15 days prior to enrolment
7. Dermatological pathology on back
8. Acute and evolutive disease
9. Blood donation in three months prior to enrolment
10. In a period of exclusion following previous clinical trials
11. Having received 3800 or more Euros in preceeding 12 months from participation in clinical trials
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Vaccine/immunisation
Infections and Infestations
Vaccination
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Intervention(s)
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Intervention: 1 dose of Rouvax® vaccine administered to the skin of the shoulder after stripping (abrading) the skin
Control: 1 dose of Rouvax® administered by injection
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Primary Outcome(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
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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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