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ISRCTN
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ISRCTN88861431
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ClinicalTrials.gov identifier
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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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Acronym
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N/A
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Serial number at source
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RPC 037
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Ethics approval received on the 23rd March 2004.
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Study design
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Randomised controlled trial
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Countries of recruitment
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France
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Disease/condition/study domain
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Vaccine/immunisation
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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23/03/2004
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Anticipated end date
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23/03/2005
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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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Not provided at time of registration
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Interventions
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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 measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
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Trial website
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Publications
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Contact name
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Dr
Martin
Friede
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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 4398
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Email
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friedem@who.int
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Sponsor
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World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (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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Sponsor website:
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http://www.who.int
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Date applied
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25/11/2005
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Last edited
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26/03/2008
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Date ISRCTN assigned
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25/11/2005
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