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Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia

NCT03095326 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2017-03-29

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Zinc

formula of ZnSO4, usually used to treat zinc deficiency.

DRUG

Sucrose

Placebo of sucrose syrup

BIOLOGICAL

PCV Vaccine

Pneumococcal conjugate vaccine

BIOLOGICAL

PPV Vaccine

Pneumococcal polysaccharide vaccine

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Indonesia

    lead OTHER

Principal Investigators

  • Teny T Sari, M.D, PhD · Faculty of Medicine University of Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-01
Primary Completion
2014-02-01
Completion
2014-02-01

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095326 on ClinicalTrials.gov