A strategy to immunize young infants against measles

ISRCTN	ISRCTN45483324
DOI	https://doi.org/10.1186/ISRCTN45483324
Secondary identifying numbers	SCC 948

Submission date: 15/09/2005
Registration date: 03/11/2005
Last edited: 28/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hilton Whittle
Scientific

MRC Laboratories
Fajara
PMB243
Gambia

Phone	+220 4496715
Email	hwhittle@mrc.gm

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title	A strategy to immunize young infants against measles
Study objectives	Immunogenicity of Edmonston-Zagreb measles vaccine given at 4 and 9 months of age will be superior to that of the vaccine given at 9 months of age
Ethics approval(s)	Added as of 30/07/2007: This trial was approved by: 1. The Gambia Government / Medical Research Council Ethics Committee 2. The London School of Hygiene and Tropical Medicine
Health condition(s) or problem(s) studied	Measles
Intervention	Edmonston-Zagreb measles vaccine given at 4 and 9 months of age versus vaccine given at 9 months of age
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Edmonston-Zagreb measles vaccine
Primary outcome measure	Gamma interferon elispot counts after stimulation of peripheral blood mononuclear cells with measles virus at 18 months of age
Secondary outcome measures	Measles haemagglutinin inhibiting antibody at 18 months of age
Overall study start date	02/07/2003
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	150
Total final enrolment	132
Key inclusion criteria	Healthy children whose parents agree to the trial
Key exclusion criteria	Malnourished children or those with a febrile illness
Date of first enrolment	02/07/2003
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Gambia

Study participating centre

MRC Laboratories

Fajara
PMB243
Gambia

Sponsor information

Medical Research Council (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	markpalmer@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk
"ROR"	https://ror.org/03x94j517

Funders

Funder type

Research council

Medical Research Council (MRC) (SCC948)(UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results at 3 year booster	28/03/2012	28/10/2021	Yes	No

Editorial Notes

28/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.