Status:
COMPLETED
Dynamics of the Immune Response in Children to the 23-valent Pneumococcal Capsular Polysaccharide Vaccine (Pneumovax)
Lead Sponsor:
KEMRI-Wellcome Trust Collaborative Research Program
Conditions:
Pneumonia, Pneumococcal
Eligibility:
All Genders
24-36 years
Phase:
PHASE1
Brief Summary
To explore a further dimension of susceptibility to disease, the investigators tested the hypothesis that natural variation exists in the rapidity of IgG responses following exposure to pneumococcal p...
Detailed Description
The details are as described below: 1. Study site Kilifi District Hospital. 2. Study population and sampling Cases and controls from the Kilifi Birth Cohort who are alive at the end of the cohort obs...
Eligibility Criteria
Inclusion
- Pilot study (study 1)
- A convenience sample of 40 children aged 24-36 248 months was selected from among healthy siblings of patients admitted to the 249 paediatric ward in Kilifi District Hospital and who lived within 30km of the hospital.
Exclusion
- Subjects were excluded if they had any of the following:
- a history of invasive pneumococcal infection including pneumonia, bacteremia, or meningitis documented at the hospital;
- a history of previous vaccination with any pneumococcal vaccine;
- receipt of any other vaccine in the last 2 months;
- admission to hospital in the last 3months;
- malnutrition, as defined by a weight-for-age z-score of \<-3.0; or
- HIV infection.
- Study 2
- Inclusion Criteria:
- Thirty children who had recovered from an episode of invasive pneumococcal disease (the Prior IPD group) were compared with 30 healthy age-matched children who had not had IPD (the Healthy Control group). Controls were selected at random from a cohort study investigating environmental and genetic susceptibility to invasive pneumococcal disease in Kilifi District Hospital. An episode of IPD was defined as admission to hospital with cultures of blood, cerebrospinal fluid (CSF) or pleural aspirate that grew S. pneumoniae.
Key Trial Info
Start Date :
November 4 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03460730
Start Date
November 4 2004
End Date
July 3 2006
Last Update
March 12 2018
Active Locations (1)
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1
Kilifi District Hospital
Kilifi, Coast, Kenya