Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia

Thalassemia Clinical Trial

Official title:

Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095326
• Other study ID #: 01
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2017
• Last updated: March 28, 2017
• Start date: September 1, 2013
• Est. completion date: February 1, 2014

Study information

• Verified date: March 2017
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 1, 2014
• Est. primary completion date: February 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Splenectomised thalassemia patient

Exclusion Criteria:

• non-splenectomised thalassemia patient

Related Conditions & MeSH terms

• beta-Thalassemia
• Pneumococcal Infection
• Pneumococcal Infections
• Thalassemia

Intervention

Dietary Supplement:
• Zinc
formula of ZnSO4, usually used to treat zinc deficiency.

Drug:
• Sucrose
Placebo of sucrose syrup

Biological:
• PCV Vaccine
Pneumococcal conjugate vaccine
• PPV Vaccine
Pneumococcal polysaccharide vaccine

Locations

Country	Name	City	State
Indonesia	Fakultas Kedokteran Universitas Indonesia	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumococcal IgG	Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency	week 12