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Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia

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ClinicalTrials.gov Identifier: NCT03095326
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Thalassemia Pneumococcal Infection Dietary Supplement: Zinc Drug: Sucrose Biological: PCV Vaccine Biological: PPV Vaccine 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Investigator)
Masking Description: The participant are divided into two different groups, which are assigned with either zinc or placebo
Primary Purpose: Prevention
Official Title: Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : February 1, 2014
Actual Study Completion Date : February 1, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia
Drug Information available for: Sucrose

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 Name: Zinc sulfate

Biological: PCV Vaccine
Pneumococcal conjugate vaccine
Other Name: Prevenar 13®

Biological: PPV Vaccine
Pneumococcal polysaccharide vaccine
Other Name: Pneumovax®

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 Name: Sucrose syrup

Biological: PCV Vaccine
Pneumococcal conjugate vaccine
Other Name: Prevenar 13®

Biological: PPV Vaccine
Pneumococcal polysaccharide vaccine
Other Name: Pneumovax®




Primary Outcome Measures :
  1. Pneumococcal IgG [ Time Frame: week 12 ]
    Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Splenectomised thalassemia patient

Exclusion Criteria:

  • non-splenectomised thalassemia patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095326


Locations
Indonesia
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

Responsible Party: Fakultas Kedokteran Universitas Indonesia
ClinicalTrials.gov Identifier: NCT03095326     History of Changes
Other Study ID Numbers: 01
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Thalassemia
beta-Thalassemia
Pneumococcal Infections
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Zinc
Zinc Sulfate
Immunologic Factors
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances
Astringents
Dermatologic Agents