Study of safety and immunogenicity of Measles vaccine (Rouvax®) administered by transcutaneous route (France)

ISRCTN ISRCTN88861431
DOI https://doi.org/10.1186/ISRCTN88861431
Secondary identifying numbers RPC 037
Submission date
25/11/2005
Registration date
25/11/2005
Last edited
26/03/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Martin Friede
Scientific

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Phone +41 (0)22 791 4398
Email friedem@who.int

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Ethics approval received on the 23rd March 2004.
Health condition(s) or problem(s) studiedVaccine/immunisation
InterventionIntervention: 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Measles vaccine (Rouvax®)
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date23/03/2004
Completion date23/03/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment23/03/2004
Date of final enrolment23/03/2005

Locations

Countries of recruitment

  • France
  • Switzerland

Study participating centre

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor information

World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
University/education

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Website http://www.who.int
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Research organisation

World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan