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Main
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Note: This record shows only 22 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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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03460730 |
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Date of registration:
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20/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dynamics of the Immune Response in Children to the 23-valent Pneumococcal Capsular Polysaccharide Vaccine (Pneumovax)
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Scientific title:
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Dynamics of the Immune Response in Children to the 23-valent Pneumococcal Capsular Polysaccharide Vaccine (Pneumovax) |
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Date of first enrolment:
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November 4, 2004 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03460730 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Anthony Scott, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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KEMRI-Wellcome Trust Collaborative Research Program |
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Key inclusion & exclusion criteria
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Pilot study (study 1)
Inclusion Criteria:
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 Criteria:
Subjects were excluded if they had any of the following:
1. a history of invasive pneumococcal infection including pneumonia, bacteremia, or
meningitis documented at the hospital;
2. a history of previous vaccination with any pneumococcal vaccine;
3. receipt of any other vaccine in the last 2 months;
4. admission to hospital in the last 3months;
5. malnutrition, as defined by a weight-for-age z-score of <-3.0; or
6. 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.
Exclusion Criteria:
Same as for Study 1 (pilot) except that for the Prior IPD group, history of invasive
pneumococcal disease was an inclusion criterion.
Age minimum:
24 Months
Age maximum:
36 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pneumonia, Pneumococcal
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Intervention(s)
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Biological: Pneumovax
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Primary Outcome(s)
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Study 2 Proportional IgG Response to serotypes 1, 6B, 14, 19F and 23F within 7 days
[Time Frame: day 0, day 7, day 11 after vaccination]
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Study 1 - Pilot study: Time to reach the "response threshold" in IgG concentration to serotypes 1, 6B, 14, 19F and 23F
[Time Frame: day 0, 5, 7, 9, 11, 14 and 28 days after vaccination]
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Secondary ID(s)
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SSC 613
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KEMRI_CT_2018\0022
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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