Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
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| ClinicalTrials.gov Identifier: NCT03095326 |
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Recruitment Status :
Completed
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Thalassemia Pneumococcal Infection | Dietary Supplement: Zinc Drug: Sucrose Biological: PCV Vaccine Biological: PPV Vaccine | Phase 4 |
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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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® |
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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.
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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® |
- Pneumococcal IgG [ Time Frame: week 12 ]Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Splenectomised thalassemia patient
Exclusion Criteria:
- non-splenectomised thalassemia patient
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
| Indonesia | |
| Fakultas Kedokteran Universitas Indonesia | |
| Jakarta Pusat, Jakarta, Indonesia, 10430 | |
| Principal Investigator: | Teny T Sari, M.D, PhD | Faculty of Medicine University of Indonesia |
| Responsible Party: | Fakultas Kedokteran Universitas Indonesia |
| ClinicalTrials.gov Identifier: | NCT03095326 |
| 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 |
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Pneumococcal Infections Thalassemia beta-Thalassemia Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |
Bacterial Infections and Mycoses Infections Zinc Zinc Sulfate Vaccines Immunologic Factors Physiological Effects of Drugs Trace Elements Micronutrients Astringents Dermatologic Agents |