Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia

Study Overview
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Brief Summary
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Splenectomized thalassemia major subjects were provided with PCV pneumococcal vaccine (Prevenar 13®) at the start of the trial, following which they were randomly assigned to 2 groups (zinc and placebo group). After 8 weeks, the subjects received PPV pneumococcal vaccine (Pneumovax®). Zinc syrup was provided to the zinc group at a dose of 1.5 mg/kg/day (maximum of 50 mg/day). Pneumococcal IgG examinations were conducted at the start of the trial and after 12 weeks.

Detailed Description
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This study is a single blinded randomised-control trial. Splenectomized thalassemia major patient samples were provided with PCV pneumococcal vaccine (Prevenar 13®) at the start of the trial, following which they were randomly assigned to 2 groups (zinc and placebo group). After 8 weeks, the subjects received PPV pneumococcal vaccine (Pneumovax®). Zinc syrup was provided to the zinc group at a dose of 1.5 mg/kg/day (maximum of 50 mg/day). Placebo containing sucrose syrup of the same form, taste, consistency and color was given to the other group. Everyone except the primary researcher are blinded to which of the treatment is placebo and which is actual zinc syrup. Pneumococcal IgG examinations were conducted at the start of the trial and after 12 weeks. 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.

Official Title
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Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia

Conditions
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Thalassemia, Pneumococcal Infection

Intervention / Treatment
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* Dietary Supplement: Zinc
* Drug: Sucrose
* Biological: PCV Vaccine
* Biological: PPV Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Splenectomised thalassemia patient Exclusion Criteria: non-splenectomised thalassemia patient
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All splenectomized thalassemia major subjects were provided with PCV pneumococcal vaccine (Prevenar 13®) at the start of the trial. The subjects were then randomly assigned into one of 2 groups (the zinc group and the placebo group). Zinc was provided in the form of syrup at a dose of 1.5 mg/kg/day, with a maximum of 50 mg/day. The placebo was also provided in the form of syrup, with similar shape and flavor.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc Syrup 1.5 mg/kgbw/day<br>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. | Dietary Supplement: Zinc<br>* formula of ZnSO4, usually used to treat zinc deficiency.<br>* Other names: Zinc sulfate;Biological: PCV Vaccine<br>* Pneumococcal conjugate vaccine<br>* Other names: Prevenar 13®;Biological: PPV Vaccine<br>* Pneumococcal polysaccharide vaccine<br>* Other names: Pneumovax®;|
| Placebo Comparator: Sucrose syrup<br>Patient were given sucrose syrup as placebo. The syrup was made in the same flavor and consistency as the zinc syrup. | Drug: Sucrose<br>* Placebo of sucrose syrup<br>* Other names: Sucrose syrup;Biological: PCV Vaccine<br>* Pneumococcal conjugate vaccine<br>* Other names: Prevenar 13®;Biological: PPV Vaccine<br>* Pneumococcal polysaccharide vaccine<br>* Other names: Pneumovax®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumococcal IgG | Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency | week 12 |