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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201008000221638 |
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Date of registration:
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15/06/2010 |
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Primary sponsor: |
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Public title:
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Safety of Malaria vaccines in Gambian adults , children and infants
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Scientific title:
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Safety and immunogenicity of a heterologous prime-bosst vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults, children and infants in a malaria endemic area |
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Date of first enrolment:
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2010-06-15 |
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Target sample size:
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52 |
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Recruitment status: |
Closed to recruitment: follow up continuing |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201008000221638 |
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Study type:
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interventional |
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Study design:
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Single group: all participants receive same intervention throughout study,
Randomised,
simple randomisation using a computer sofware programme for the paediatric study,
Allocation was determined by study statistician who is situated off site,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Muhammed
Afolabi |
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Address:
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Atlantic Boulevard
PO Box 273, Banjul
Fajara
Gambia |
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Telephone:
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220 4494072-9 |
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Email:
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mafolabi@mrc.gm |
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Affiliation:
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Research clinician |
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Name:
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Sanneh
Mamkumba |
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Address:
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Atlantic Boulevard, Fajara
PO Box 273
Banjul
Gambia |
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Telephone:
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220 4494072-9 |
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Email:
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msanneh@mrc.gm |
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Affiliation:
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Project Manager |
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Key inclusion & exclusion criteria
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Inclusion criteria: Consenting adult males and children aged 2-6 years in good health
Exclusion criteria: Any of the following constitute an exclusion criterion:
?Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
?History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon.
?History of splenectomy.
?Haemoglobin less than 9.0 g/dL
?Serum creatinine concentration above b130mmol/L
?Serum ALT concentration b69 IU/L
?Blood transfusion within one month ofenrolment. .
?History of vaccination with previous experimental malaria vaccines.
?Administration of any other vaccine or immunoglobulin within two weeks before vaccination.
?Current participation in another clinical trial, or within 12 weeks of this study.
?Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
?Likelihood of travel away from the study area.
?HIV positive.
Age minimum:
2 Year
Age maximum:
50 Year
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Malaria
null
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Primary Outcome(s)
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Local and systemic solicited and unsolicited adverse events
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Source(s) of Monetary Support
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EDCTP
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