Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Dietary Supplement: Zinc
formula of ZnSO4, usually used to treat zinc deficiency.
Other Names:
Biological: PCV Vaccine
Pneumococcal conjugate vaccine
Other Names:
Biological: PPV Vaccine
Pneumococcal polysaccharide vaccine
Other Names:
|
| Placebo Comparator: Sucrose syrup Patient were given sucrose syrup as placebo. The syrup was made in the same flavor and consistency as the zinc syrup. |
Drug: Sucrose
Placebo of sucrose syrup
Other Names:
Biological: PCV Vaccine
Pneumococcal conjugate vaccine
Other Names:
Biological: PPV Vaccine
Pneumococcal polysaccharide vaccine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pneumococcal IgG [week 12]
Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency
Eligibility Criteria
Criteria
Inclusion Criteria:
- Splenectomised thalassemia patient
Exclusion Criteria:
- non-splenectomised thalassemia patient
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fakultas Kedokteran Universitas Indonesia | Jakarta Pusat | Jakarta | Indonesia | 10430 |
Sponsors and Collaborators
- Fakultas Kedokteran Universitas Indonesia
Investigators
- Principal Investigator: Teny T Sari, M.D, PhD, Faculty of Medicine University of Indonesia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 01