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Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia

Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03095326
Enrollment
56
Registered
2017-03-29
Start date
2013-09-01
Completion date
2014-02-01
Last updated
2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infection, Thalassemia

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.

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.

Interventions

DIETARY_SUPPLEMENTZinc

formula of ZnSO4, usually used to treat zinc deficiency.

DRUGSucrose

Placebo of sucrose syrup

BIOLOGICALPCV Vaccine

Pneumococcal conjugate vaccine

BIOLOGICALPPV Vaccine

Pneumococcal polysaccharide vaccine

Sponsors

Fakultas Kedokteran Universitas Indonesia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

The participant are divided into two different groups, which are assigned with either zinc or placebo

Intervention 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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Splenectomised thalassemia patient

Exclusion criteria

* non-splenectomised thalassemia patient

Design outcomes

Primary

MeasureTime frameDescription
Pneumococcal IgGweek 12Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026