Safety IssuesPhase 3NCT04051268
Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
A Phase 3 study testing Vi-DT Typhoid Conjugate Vaccine, PQed Typhoid Conjugate Vaccine and Vi Polysaccharide Vaccine in people with Safety Issues and Immunogenicity, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine. Read more about this study
- Who is it for?
- Ages 6 months to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Immunogenicity
- What is being tested?
- Vi-DT Typhoid Conjugate Vaccine, PQed Typhoid Conjugate Vaccine and Vi Polysaccharide Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,071 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Mar 2020to 1 Dec 2021
- Phase
- Phase 3
- 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 6 months to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy.
- Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form.
- Subject/parents/legal guardian(s) 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 (axilary 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, corticosteroid therapy and other immunosuppressants)
- 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 vaccinated with any vaccine within one month prior and expect to receive other vaccines within one month following vaccination except MR (Measles Rubella) vaccine.
- Individuals who have a previously ascertained typhoid fever by laboratory confirmation (blood culture/new rapid test) at any time.
- Subject planning to move from the study area before the end of study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to Lot Consistency, Non-inferiority to PQed (Prequalified) TCV (Typhoid Conjugate Vaccine)
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.
Read the detailed description
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and to Typhoid Vi polysaccharide vaccine.
Involved participants aged 6 months old to 60 years old.
- Conditions
- Safety Issues, Immunogenicity
- Being tested
- Vi-DT Typhoid Conjugate Vaccine, PQed Typhoid Conjugate Vaccine, Vi Polysaccharide Vaccine
- Keywords
- Vaccine, Typhoid Conjugate Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vi-DT Typhoid Conjugate VaccineBiological
1 dose of Investigational Product
PQed Typhoid Conjugate VaccineBiological
1 dose of Active Comparator
Vi Polysaccharide VaccineBiological
1 dose of Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Vi-DT TCV Batch 1 | Experimental | 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 1 Receives: Biological: Vi-DT Typhoid Conjugate Vaccine |
| Vi-DT TCV Batch 2 | Experimental | 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 2 Receives: Biological: Vi-DT Typhoid Conjugate Vaccine |
| Vi-DT TCV Batch 3 | Experimental | 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 3 Receives: Biological: Vi-DT Typhoid Conjugate Vaccine |
| PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo) | Active comparator | 1 dose of 0.5 ml of PQed TCV Vaccine Receives: Biological: PQed Typhoid Conjugate Vaccine |
| Vi Polysaccharide Vaccine (subjects 46-60 years old) | Active comparator | 1 dose of 0.5 ml of Vi Polysaccharide Vaccine Receives: Biological: Vi Polysaccharide Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants.
Measured: 28 days
Secondary outcomes (3)
Describe antibody response following vaccination
Comparison of GMT, seroconversion between each lot number of Vi-DT (Bio Farma ) vaccine in each group.
Measured: 28 days
Adverse event, solicited or unsolicited
Number and percentage with at least one adverse event, solicited or unsolicited, within 30 minutes, 72 hours, 7 days, and 28 days after vaccination.
Measured: 28 days
Comparison the safety and immunogenicity
Comparison of adverse events occuring until 28 days after vaccination between each lot number of Vi-DT (Bio Farma ) vaccine and PQed typhoid conjugate vaccine
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 posted9 Aug 2019
- Study start2 Mar 2020
- Primary completion24 Nov 2021
- Study completion1 Dec 2021
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects 6 months - 45 years of age: Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine Subjects 46 - 60 years of age: Randomized, observer blind, lot to lot consistency, superiority to Vi polysaccharide vaccine. Subjects 6 months - 60 years old: Randomized, observer blind, lot to lot consistency
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,071 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernie E Medise, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051268
- Sponsor's protocol ID
- Typhoid 0319
- Status last verified
- Dec 2021
- First submitted
- 6 Aug 2019
- Last updated
- 4 Jan 2022
- 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 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to Lot Consistency, Non-inferiority to PQed (Prequalified) TCV (Typhoid Conjugate Vaccine)
- ClinicalTrials.gov ID
- NCT04051268
- Acronym / sponsor ID
- Typhoid 0319
- Conditions
- Safety Issues, Immunogenicity
- Keywords
- Vaccine, Typhoid Conjugate Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,071 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 9 Aug 2019 (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.
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.
Detailed description
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and to Typhoid Vi polysaccharide vaccine.
Involved participants aged 6 months old to 60 years old.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Subjects 6 months - 45 years of age: Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine Subjects 46 - 60 years of age: Randomized, observer blind, lot to lot consistency, superiority to Vi polysaccharide vaccine. Subjects 6 months - 60 years old: Randomized, observer blind, lot to lot consistency
| Arm | Type | Receives |
|---|---|---|
| Vi-DT TCV Batch 1 | Experimental | Biological: Vi-DT Typhoid Conjugate Vaccine1 dose of 0.5 ml of Vi-DT TCV vaccine batch 1 |
| Vi-DT TCV Batch 2 | Experimental | Biological: Vi-DT Typhoid Conjugate Vaccine1 dose of 0.5 ml of Vi-DT TCV vaccine batch 2 |
| Vi-DT TCV Batch 3 | Experimental | Biological: Vi-DT Typhoid Conjugate Vaccine1 dose of 0.5 ml of Vi-DT TCV vaccine batch 3 |
| PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo) | Active comparator | Biological: PQed Typhoid Conjugate Vaccine1 dose of 0.5 ml of PQed TCV Vaccine |
| Vi Polysaccharide Vaccine (subjects 46-60 years old) | Active comparator | Biological: Vi Polysaccharide Vaccine1 dose of 0.5 ml of Vi Polysaccharide Vaccine |
Who may qualify
- Ages
- 6 months to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy.
- Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form.
- Subject/parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.
Key exclusion criteria (11 listed)
- Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axilary 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, corticosteroid therapy and other immunosuppressants)
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 Typhoid Conjugate Vaccine1 dose of Investigational Product | Biological | Vi-DT TCV Batch 1, Vi-DT TCV Batch 2, Vi-DT TCV Batch 3 |
| PQed Typhoid Conjugate Vaccine1 dose of Active Comparator | Biological | PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo) |
| Vi Polysaccharide Vaccine1 dose of Active Comparator | Biological | Vi Polysaccharide Vaccine (subjects 46-60 years old) |
Primary outcome
Immunogenicity
Time frame: 28 days
Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants.
3 secondary outcomes
Describe antibody response following vaccination
Time frame: 28 days
Adverse event, solicited or unsolicited
Time frame: 28 days
Comparison the safety and immunogenicity
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 4 Jan 2022.
- 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 E Medise, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vi-DT Typhoid Conjugate Vaccine, PQed Typhoid Conjugate Vaccine and Vi Polysaccharide Vaccine in people with Safety Issues and Immunogenicity, run by PT Bio Farma 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 3 inclusion and 11 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 4 Jan 2022. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Immunogenicity (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 4 Jan 2022.