Contact information
Type
Scientific
Primary contact
Dr Martin Friede
ORCID ID
Contact details
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 4398
friedem@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPC 037
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Ethics approval received on the 23rd March 2004.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Vaccine/immunisation
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
Measles vaccine (Rouvax®)
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
23/03/2004
Overall trial end date
23/03/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
23/03/2004
Recruitment end date
23/03/2005
Locations
Countries of recruitment
France
Trial participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Sponsor details
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary