Safety of Malaria vaccines in Gambian childre

Not Applicable

• Conditions: Paediatrics; Malaria

• Registration Number: PACTR201204000362870
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-26
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

¿A male or female between, and including, 2 and 6 years of age at the time of the first vaccination.
¿Written informed consent obtained from the subject¿s parents.
¿Free of obvious health problems as established by medical history and clinical examination before entering into the study.
¿Availability for the duration of the immunization and follow-up period.

Exclusion Criteria

¿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.
¿Severe malnutrition, defined as weight-for-height z-score <-3 or oedema of both feet (WHO)
¿Hypersensitivity to HDCRV.
¿History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.
¿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 of enrolment.
¿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
¿Occurrence of solicited events after each vaccination ;¿Occurrence of unsolicited symptoms after each vaccination ;¿Occurrence of solicited events after each vaccination ;¿Occurrence of unsolicited symptoms after each vaccination