Condition category
Infections and Infestations
Date applied
02/05/2007
Date assigned
02/05/2007
Last edited
29/07/2008
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 G. Berbers

ORCID ID

Contact details

National Institute for Public Health and the Environment (RIVM)
P.O. Box 1
Bilthoven
3720 BA
Netherlands
+31 (0)30 274 2496
guy.berbers@rivm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LTR086a

Study information

Scientific title

Acronym

Study hypothesis

Measles, Mumps and Rubella (MMR) vaccine administered intramuscularly induces the same adverse effects and immunogenicity as subcutaneously.

Ethics approval

Approval received from the TNO Preventie en Gezondheid (this
committee ceased to exist as of 01-Jan-2004) on the 20th January 1999 (ref: METC 98/61).

Study design

Non-randomised, interventional, parallel group trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Measles Mumps Rubella (MMR) vaccination

Intervention

Two groups of children aged 14 months:
1. MMR vaccine (RVG number 17654) given subcutaneously (n = 34)
2. MMR vaccine (RVG number 17654) given intramuscularly (n = 34)

Intervention type

Drug

Phase

Not Specified

Drug names

Measles, Mumps and Rubella (MMR) vaccine

Primary outcome measures

The occurrence of adverse events after the MMR vaccine administered subcutaneously versus intramuscularly as recorded by the parents (non-blinded).

Secondary outcome measures

The immunogenicity of the MMR vaccine administered subcutaneously versus intramuscularly as measured by the antibody titres before and 12 weeks after vaccination. Antibody titres are determined by a twofold serial dilution Enzyme Linked Immunosorbert Assay (ELISA).

Overall trial start date

01/02/1998

Overall trial end date

01/09/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 12 to 18 months
2. In good general health

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

67

Participant exclusion criteria

1. Proven allergy for any of the vaccine components
2. Contraindication for MMR vaccination (e.g. administration of blood products within three months before MMR vaccination)
3. Known immune disorder
4. Coagulation disorder (not being able to receive intramuscular injection)
5. Parents/legal representatives who cannot participate optimally in the trial due to, e.g., language issues
6. Previous MMR vaccination
7. Administration of another vaccine simultaneous to the MMR vaccination

Recruitment start date

01/02/1998

Recruitment end date

01/09/2001

Locations

Countries of recruitment

Netherlands

Trial participating centre

National Institute for Public Health and the Environment (RIVM)
Bilthoven
3720 BA
Netherlands

Sponsor information

Organisation

National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)

Sponsor details

P.O. Box 1
Bilthoven
3720 BA
Netherlands
+31 (0)30 274 9111
info@rivm.nl

Sponsor type

Government

Website

http://www.rivm.nl/en/

Funders

Funder type

Government

Funder name

The Netherlands Healthcare Inspectorate (The Netherlands)

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

Results in http://www.rivm.nl/bibliotheek/rapporten/000002001.html

Publication citations

Additional files

Editorial Notes