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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

Tracking Information
First Submitted Date  ICMJE March 15, 2017
First Posted Date  ICMJE March 29, 2017
Last Update Posted Date March 29, 2017
Actual Study Start Date  ICMJE September 1, 2013
Actual Primary Completion Date February 1, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
Pneumococcal IgG [ Time Frame: week 12 ]
Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
Official Title  ICMJE Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Thalassemia
  • Pneumococcal Infection
Intervention  ICMJE
  • Dietary Supplement: Zinc
    formula of ZnSO4, usually used to treat zinc deficiency.
    Other Name: Zinc sulfate
  • 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®
Study Arms  ICMJE
  • 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.
    Interventions:
    • Dietary Supplement: Zinc
    • Biological: PCV Vaccine
    • Biological: PPV Vaccine
  • 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.
    Interventions:
    • Drug: Sucrose
    • Biological: PCV Vaccine
    • Biological: PPV Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2017)
56
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 1, 2014
Actual Primary Completion Date February 1, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Splenectomised thalassemia patient

Exclusion Criteria:

  • non-splenectomised thalassemia patient
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03095326
Other Study ID Numbers  ICMJE 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fakultas Kedokteran Universitas Indonesia
Study Sponsor  ICMJE Fakultas Kedokteran Universitas Indonesia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Teny T Sari, M.D, PhD Faculty of Medicine University of Indonesia
PRS Account Fakultas Kedokteran Universitas Indonesia
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP