Measles, mumps and rubella vaccine given to 14 month old children, administered subcutaneously versus intramuscularly

ISRCTN	ISRCTN61378987
DOI	https://doi.org/10.1186/ISRCTN61378987
Secondary identifying numbers	LTR086a

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr G. Berbers
Scientific

National Institute for Public Health and the Environment (RIVM)
P.O. Box 1
Bilthoven
3720 BA
Netherlands

Phone	+31 (0)30 274 2496
Email	guy.berbers@rivm.nl

Study design	Non-randomised, interventional, parallel group trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title
Study objectives	Measles, Mumps and Rubella (MMR) vaccine administered intramuscularly induces the same adverse effects and immunogenicity as subcutaneously.
Ethics approval(s)	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).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Measles, Mumps and Rubella (MMR) vaccine
Primary outcome measure	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 study start date	01/02/1998
Completion date	01/09/2001

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Months
Upper age limit	18 Months
Sex	Not Specified
Target number of participants	67
Key inclusion criteria	1. Children aged 12 to 18 months 2. In good general health
Key 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
Date of first enrolment	01/02/1998
Date of final enrolment	01/09/2001

National Institute for Public Health and the Environment (RIVM)

Bilthoven
3720 BA
Netherlands

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

P.O. Box 1
Bilthoven
3720 BA
Netherlands

Government

The Netherlands Healthcare Inspectorate (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	26/10/2001		Yes	No