Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia

NCT03095326 | Completed Phase 4

• 1 other identifier: 01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Thalassemia; Pneumococcal Infection

Outcome Measures

Primary Outcomes (1)

• Pneumococcal IgG

  Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency

  week 12

Study Arms (2)

Zinc Syrup 1.5 mg/kgbw/day

EXPERIMENTAL

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; Biological: PCV Vaccine; Biological: PPV Vaccine

Sucrose syrup

PLACEBO COMPARATOR

Patient were given sucrose syrup as placebo. The syrup was made in the same flavor and consistency as the zinc syrup.

Drug: Sucrose; Biological: PCV Vaccine; Biological: PPV Vaccine

Interventions

Zinc DIETARY_SUPPLEMENT

formula of ZnSO4, usually used to treat zinc deficiency.

Also known as: Zinc sulfate

Zinc Syrup 1.5 mg/kgbw/day

Sucrose DRUG

Placebo of sucrose syrup

Also known as: Sucrose syrup

Sucrose syrup

PCV Vaccine BIOLOGICAL

Pneumococcal conjugate vaccine

Also known as: Prevenar 13®

Sucrose syrup; Zinc Syrup 1.5 mg/kgbw/day

PPV Vaccine BIOLOGICAL

Pneumococcal polysaccharide vaccine

Also known as: Pneumovax®

Sucrose syrup; Zinc Syrup 1.5 mg/kgbw/day

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Splenectomised thalassemia patient

You may not qualify if:

• non-splenectomised thalassemia patient

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

Study Sites (1)

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Thalassemia; Pneumococcal Infections

Interventions

Zinc; Zinc Sulfate; Sucrose; five-valent pneumococcal conjugate vaccine; 13-valent pneumococcal vaccine; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Zinc Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Teny T Sari, M.D, PhD

  Faculty of Medicine University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The participant are divided into two different groups, which are assigned with either zinc or placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 29, 2017
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)