Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia

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

Tracking Information

• First Submitted Date: March 15, 2017
• First Posted Date: March 29, 2017
• Last Update Posted Date: March 29, 2017
• Actual Study Start Date: September 1, 2013
• Actual Primary Completion Date: February 1, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 28, 2017)

Pneumococcal IgG [ Time Frame: week 12 ]

Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
• Official Title: 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: Interventional
• Study Phase: Phase 4

Study Design

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

• Thalassemia
• Pneumococcal Infection

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 28, 2017): 56
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 1, 2014
• Actual Primary Completion Date: February 1, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Splenectomised thalassemia patient

Exclusion Criteria:

• non-splenectomised thalassemia patient

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Indonesia

Administrative Information

• NCT Number: NCT03095326
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Fakultas Kedokteran Universitas Indonesia
• Original Responsible Party: Same as current
• Current Study Sponsor: Fakultas Kedokteran Universitas Indonesia
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Teny T Sari, M.D, PhD; Faculty of Medicine University of Indonesia

• PRS Account: Fakultas Kedokteran Universitas Indonesia
• Verification Date: March 2017