Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia

Phase 4

Completed

• Conditions: Pneumococcal Infection; Thalassemia
• Interventions: Dietary Supplement: Zinc; Drug: Sucrose; Biological: PCV Vaccine; Biological: PPV Vaccine

• Registration Number: NCT03095326
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

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.

Study Timeline

• Study Start: 2013-09-01
• Primary Completion: 2014-02-01
• Study Completion: 2014-02-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-28
• Last Update Submitted: 2017-03-28
• Study First Posted: 2017-03-29
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Splenectomised thalassemia patient

Exclusion Criteria

• non-splenectomised thalassemia patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc Syrup 1.5 mg/kgbw/day	PPV Vaccine	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.
Sucrose syrup	PPV Vaccine	Patient were given sucrose syrup as placebo. The syrup was made in the same flavor and consistency as the zinc syrup.
Sucrose syrup	PCV Vaccine	Patient were given sucrose syrup as placebo. The syrup was made in the same flavor and consistency as the zinc syrup.
Zinc Syrup 1.5 mg/kgbw/day	Zinc	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 Syrup 1.5 mg/kgbw/day	PCV Vaccine	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.
Sucrose syrup	Sucrose	Patient were given sucrose syrup as placebo. The syrup was made in the same flavor and consistency as the zinc syrup.

Primary Outcome Measures

Name	Time	Method
Pneumococcal IgG	week 12	Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency

Trial Locations

Locations (1)

Fakultas Kedokteran Universitas Indonesia; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia