Study of safety and immunogenicity of Measles vaccine (Rouvax®) administered by transcutaneous route (France)
| ISRCTN | ISRCTN88861431 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88861431 |
| Protocol serial number | RPC 037 |
| Sponsor | World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland) |
| Funder | World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland) |
- 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
Scientific
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| Phone | +41 (0)22 791 4398 |
|---|---|
| friedem@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Ethics approval received on the 23rd March 2004. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Measles vaccine (Rouvax®) |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 23/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Key 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 |
| Key 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 |
| Date of first enrolment | 23/03/2004 |
| Date of final enrolment | 23/03/2005 |
Locations
Countries of recruitment
- France
- Switzerland
Study participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
