Safety of Malaria vaccines in Gambian adults , children and infants

Not Applicable

• Conditions: Malaria

• Registration Number: PACTR201008000221638
• Lead Sponsor: Oxford University, Jenner Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: Male
• Target Recruitment: 52

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 >130mmol/L
¿Serum ALT concentration >69 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocal and systemic solicited and unsolicited adverse events