Condition category
Infections and Infestations
Date applied
15/09/2005
Date assigned
03/11/2005
Last edited
30/07/2007
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

Prof Hilton Whittle

ORCID ID

Contact details

MRC Laboratories
Fajara
PMB243
Gambia
+220 4496715
hwhittle@mrc.gm

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SCC 948

Study information

Scientific title

Acronym

Study hypothesis

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

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Edmonston-Zagreb measles vaccine

Primary outcome measures

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 trial start date

02/07/2003

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy children whose parents agree to the trial

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

150

Participant exclusion criteria

Malnourished children or those with a febrile illness

Recruitment start date

02/07/2003

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Gambia

Trial participating centre

MRC Laboratories
Fajara
PMB243
Gambia

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
markpalmer@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (SCC948)(UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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