Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
NCT ID: NCT03095326
Last Updated: 2017-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
56 participants
INTERVENTIONAL
2013-09-01
2014-02-01
Brief Summary
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Detailed Description
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Sample size was measured using:
n1=n2=n= {((Zα+Zβ) Sd)/d}\^2 where N = number of subject Za = degree of significance (5%), a = 5% Zb = strength of study (80%). b = 20% Sd = standard deviation d = meaningful difference between the two groups The measured sample size is 816, but due to limited patient total population sampling was used instead.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Zinc Syrup 1.5 mg/kgbw/day
Patient were given zinc formula in the form of syrup with dosage of 1.5 mg/kg body weight/day with a maximum dose of 50 mg/day. The amount of syrup given is estimated to be enough for 4 weeks.
Zinc
formula of ZnSO4, usually used to treat zinc deficiency.
PCV Vaccine
Pneumococcal conjugate vaccine
PPV Vaccine
Pneumococcal polysaccharide vaccine
Sucrose syrup
Patient were given sucrose syrup as placebo. The syrup was made in the same flavor and consistency as the zinc syrup.
Sucrose
Placebo of sucrose syrup
PCV Vaccine
Pneumococcal conjugate vaccine
PPV Vaccine
Pneumococcal polysaccharide vaccine
Interventions
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Zinc
formula of ZnSO4, usually used to treat zinc deficiency.
Sucrose
Placebo of sucrose syrup
PCV Vaccine
Pneumococcal conjugate vaccine
PPV Vaccine
Pneumococcal polysaccharide vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Fakultas Kedokteran Universitas Indonesia
OTHER
Responsible Party
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Principal Investigators
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Teny T Sari, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine University of Indonesia
Locations
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Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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Other Identifiers
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01
Identifier Type: -
Identifier Source: org_study_id
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