Condition category
Infections and Infestations
Date applied
25/11/2005
Date assigned
25/11/2005
Last edited
26/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.who.int

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

Publication citations

Additional files

Editorial Notes