Safety IssuesPhase 1NCT03109600
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
A Phase 1 study testing Vi-DT (Bio Farma), Vi polysaccharide vaccine and Influenzae vaccine in people with Safety Issues, run by PT Bio Farma at 2 sites in Indonesia.
Trial summary
This study is to assess the safety of Vi-DT vaccine in adults and children. Read more about this study
- Who is it for?
- Ages 2 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Vi-DT (Bio Farma), Vi polysaccharide vaccine and Influenzae vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesIndonesia
- Study dates
- 18 Apr 2017to 19 Feb 2018
- Phase
- Phase 1
- 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 2 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy
- Subjects/Parents have been informed properly regarding the study and signed the informed consent form
- Subject/Parents will commit to comply with the instructions of the investigator and the schedule of the trial
Who cannot join
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C )
- Known history of allergy to any component of the vaccines
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks).
- Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
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- Pregnancy \& lactation (Adults)
- Individuals who have previously received any vaccines against typhoid fever.
- Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
- Individuals who have a previously ascertained typhoid fever.
- History of alcohol or substance abuse.
- Subject planning to move from the study area before the end of study period.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Puskesmas Jatinegara
Jakarta, DKI Jaya
Jatinegara Primary Health Center
Jakarta
About this study
Official title: A Randomized, Observer Blinded, Comparative, Phase I Safety Study in Two Age De-escalating Cohorts to Assess the Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
This study is to assess the safety of Vi-DT vaccine in adults and children.
Read the detailed description
To describe the safety of this vaccine following first and second dose immunization.
To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.
- Conditions
- Safety Issues
- Being tested
- Vi-DT (Bio Farma), Vi polysaccharide vaccine, Influenzae vaccine, Pneumococcal conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vi-DT (Bio Farma)Biological
Typhoid Conjugate Vaccine
Vi polysaccharide vaccineBiological
Vi polysaccharide vaccine
Influenzae vaccineBiological
1 dose of Influenzae vaccine
Pneumococcal conjugate vaccineBiological
1 dose of Pneumococcal conjugate Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Vi-DT (Bio Farma) | Experimental | 2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine Receives: Biological: Vi-DT (Bio Farma) |
| Vi polysaccharide vaccine | Active comparator | 1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine Receives: Biological: Vi polysaccharide vaccine; Biological: Influenzae vaccine |
| Vi-DT (Bio Farma) ~ Children | Experimental | 2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine Receives: Biological: Vi-DT (Bio Farma) |
| Vi polysaccharide vaccine ~ Children | Active comparator | 1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine Receives: Biological: Vi polysaccharide vaccine; Biological: Pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local reaction and systemic event after vaccination
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.
Measured: 28 days
Secondary outcomes (5)
Adverse events after vaccination
Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each vaccination.
Measured: 28 days
Serious adverse events after vaccination
Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination and up to 6 months after the last vaccination.
Measured: 28 days
Routine laboratory evaluation that probably related to the vaccination.
Deviation from routine blood laboratory, kidney and liver function laboratory evaluation that probably related to the vaccination.
Measured: 7 days
Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)
Percentage of subjects with > 4 times increasing antibody
Measured: 28 days
Geometric Mean Titers (GMT) following immunization
Geometric Mean Titers (GMT) 28 days following immunization
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start18 Apr 2017
- Primary completion28 Sep 2017
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernie Endyarni, MD, Principal investigator, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109600
- Sponsor's protocol ID
- Typhoid 0116
- Status last verified
- Jul 2017
- First submitted
- 1 Nov 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer Blinded, Comparative, Phase I Safety Study in Two Age De-escalating Cohorts to Assess the Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
- ClinicalTrials.gov ID
- NCT03109600
- Acronym / sponsor ID
- Typhoid 0116
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 12 Apr 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.
This study is to assess the safety of Vi-DT vaccine in adults and children.
Detailed description
To describe the safety of this vaccine following first and second dose immunization.
To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vi-DT (Bio Farma) | Experimental | Biological: Vi-DT (Bio Farma)2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine |
| Vi polysaccharide vaccine | Active comparator | Biological: Vi polysaccharide vaccine, Biological: Influenzae vaccine1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine |
| Vi-DT (Bio Farma) ~ Children | Experimental | Biological: Vi-DT (Bio Farma)2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine |
| Vi polysaccharide vaccine ~ Children | Active comparator | Biological: Vi polysaccharide vaccine, Biological: Pneumococcal conjugate vaccine1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine |
Who may qualify
- Ages
- 2 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy
- Subjects/Parents have been informed properly regarding the study and signed the informed consent form
- Subject/Parents will commit to comply with the instructions of the investigator and the schedule of the trial
Key exclusion criteria (12 listed)
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C )
- Known history of allergy to any component of the vaccines
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks).
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 |
|---|---|---|
| Vi-DT (Bio Farma)Typhoid Conjugate Vaccine | Biological | Vi-DT (Bio Farma), Vi-DT (Bio Farma) ~ Children |
| Vi polysaccharide vaccineVi polysaccharide vaccine | Biological | Vi polysaccharide vaccine, Vi polysaccharide vaccine ~ Children |
| Influenzae vaccine1 dose of Influenzae vaccine | Biological | Vi polysaccharide vaccine |
| Pneumococcal conjugate vaccine1 dose of Pneumococcal conjugate Vaccine | Biological | Vi polysaccharide vaccine ~ Children |
Primary outcome
Local reaction and systemic event after vaccination
Time frame: 28 days
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.
5 secondary outcomes
Adverse events after vaccination
Time frame: 28 days
Serious adverse events after vaccination
Time frame: 28 days
Routine laboratory evaluation that probably related to the vaccination.
Time frame: 7 days
Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)
Time frame: 28 days
Geometric Mean Titers (GMT) following immunization
Time frame: 28 days
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 6 Mar 2018.
- 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.
Bernie Endyarni, MD principal investigator
Faculty of Medicine, University of Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vi-DT (Bio Farma), Vi polysaccharide vaccine and Influenzae vaccine in people with Safety Issues, run by PT Bio Farma at 2 sites 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 3 inclusion and 12 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 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Local reaction and systemic event after vaccination (time frame: 28 days). 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 6 Mar 2018.