ThalassemiaPhase 4NCT03095326
Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
A Phase 4 study testing Zinc, Sucrose and PCV Vaccine in people with Thalassemia and Pneumococcal Infection, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial 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®). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thalassemia, Pneumococcal Infection
- What is being tested?
- Zinc, Sucrose and PCV Vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2013to 1 Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Splenectomised thalassemia patient
Who cannot join
- non-splenectomised thalassemia patient
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
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.
Read the 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.
- Conditions
- Thalassemia, Pneumococcal Infection
- Being tested
- Zinc, Sucrose, PCV Vaccine, PPV Vaccine
- Medical subject headings
- Thalassemia, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDietary supplement
Also called Zinc sulfate
formula of ZnSO4, usually used to treat zinc deficiency.
SucroseDrug
Also called Sucrose syrup
Placebo of sucrose syrup
PCV VaccineBiological
Also called Prevenar 13®
Pneumococcal conjugate vaccine
PPV VaccineBiological
Also called Pneumovax®
Pneumococcal polysaccharide vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sucrose; Biological: PCV Vaccine; Biological: PPV Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumococcal IgG
Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Sep 2013
- Primary completion1 Feb 2014
- Study completion1 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teny T Sari, M.D, PhD, Principal investigator, Faculty of Medicine University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095326
- Sponsor's protocol ID
- 01
- Status last verified
- Mar 2017
- First submitted
- 15 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
- ClinicalTrials.gov ID
- NCT03095326
- Acronym / sponsor ID
- 01
- Conditions
- Thalassemia, Pneumococcal Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Feb 2014 (actual)
- Study completion
- 1 Feb 2014 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Zinc Syrup 1.5 mg/kgbw/day | Experimental | Dietary Supplement: Zinc, Biological: PCV Vaccine, Biological: PPV VaccinePatient 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. |
| Sucrose syrup | Placebo comparator | Drug: Sucrose, Biological: PCV Vaccine, Biological: PPV VaccinePatient were given sucrose syrup as placebo. The syrup was made in the same flavor and consistency as the zinc syrup. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Splenectomised thalassemia patient
Key exclusion criteria (1 listed)
- non-splenectomised thalassemia patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZincAlso: Zinc sulfateformula of ZnSO4, usually used to treat zinc deficiency. | Dietary supplement | Zinc Syrup 1.5 mg/kgbw/day |
| SucroseAlso: Sucrose syrupPlacebo of sucrose syrup | Drug | Sucrose syrup |
| PCV VaccineAlso: Prevenar 13®Pneumococcal conjugate vaccine | Biological | Sucrose syrup, Zinc Syrup 1.5 mg/kgbw/day |
| PPV VaccineAlso: Pneumovax®Pneumococcal polysaccharide vaccine | Biological | Sucrose syrup, Zinc Syrup 1.5 mg/kgbw/day |
Primary outcome
Pneumococcal IgG
Time frame: week 12
Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teny T Sari, M.D, PhD principal investigator
Faculty of Medicine University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zinc, Sucrose and PCV Vaccine in people with Thalassemia and Pneumococcal Infection, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumococcal IgG (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.