Antibody Typhoid VaccineNCT06921460
Long-Term Protection of Vi Antibodies Induced by Bio TCV in Indonesian Population Compared to PQed TCV
An observational study of Antibody Typhoid Vaccine, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. Read more about this study
- Who is it for?
- Ages 6 months to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibody Typhoid Vaccine
- How many people
- 624 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Jun 2025to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Subjects who previously enrolled in Phase 3 study Typhoid 0319 in Main Study I
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
- History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Department of Child Health Dr. Soetomo Hospital/School of Medicine, Airlangga University, Surabaya, East Java
Jakarta, DKI Jakarta
Dominicus Husada dr., SpA(K), 031-5501681, dominicushusada@yahoo.com
About this study
Official title: Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines (Bio TCV) in Indonesian Population Compared to PQed TCV
Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I.
Read the detailed description
Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. Data mainly from Asia, Africa and Latin America show that typhoid fever continues to be a public health problem in many developing countries, with school-age children (aged 5-15 years) disproportionately affected. In some endemic areas, children aged < 5 years show incidence rates similar to, or exceeding those, of school age children. WHO conservatively estimates the annual global incidence of typhoid fever at 21 million cases, of which 1-4% ends fatally. An estimated 90% of these deaths occur in Asia. Increasing multidrug resistance of S. typhi reduces the effective treatment options, increases treatment costs and results in higher rates of serious complications and deaths.
This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I. During the research, participants will make one (1) research visit to the health center for examination and blood sampling. After 5 years of being given the Typhoid vaccine, participants will be contacted by telephone to be given information about the research that will be conducted on you/your child. The research team will ask questions about the willingness to participate in the research. If they agree, a visit will be scheduled to the research site. This research is conducted by the Department of Pediatrics, Cipto Mangunkusumo Hospital, Jakarta, Dr. Soetomo Hospital, Surabaya and PT Bio Farma.
- Conditions
- Antibody Typhoid Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Test | Bio-TCV group : Blood collection for long-term protection | |
| Comparator | Typbar group : Blood collection for long-term protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate antibody persistence 5 years after vaccination with one dose of Vi-DT vaccine (Bio TCV), compared to PQed TCV (Typbar)
Measured: 5 years since got vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody Typhoid VaccineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 624 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921460
- Sponsor's protocol ID
- Typhoid-0424
- Status last verified
- Jun 2025
- First submitted
- 6 Nov 2024
- Last updated
- 3 Jun 2025
- 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines (Bio TCV) in Indonesian Population Compared to PQed TCV
- ClinicalTrials.gov ID
- NCT06921460
- Acronym / sponsor ID
- Typhoid-0424
- Conditions
- Antibody Typhoid Vaccine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Apr 2025 (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.
Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I.
Detailed description
Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. Data mainly from Asia, Africa and Latin America show that typhoid fever continues to be a public health problem in many developing countries, with school-age children (aged 5-15 years) disproportionately affected. In some endemic areas, children aged < 5 years show incidence rates similar to, or exceeding those, of school age children. WHO conservatively estimates the annual global incidence of typhoid fever at 21 million cases, of which 1-4% ends fatally. An estimated 90% of these deaths occur in Asia. Increasing multidrug resistance of S. typhi reduces the effective treatment options, increases treatment costs and results in higher rates of serious complications and deaths.
This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I. During the research, participants will make one (1) research visit to the health center for examination and blood sampling. After 5 years of being given the Typhoid vaccine, participants will be contacted by telephone to be given information about the research that will be conducted on you/your child. The research team will ask questions about the willingness to participate in the research. If they agree, a visit will be scheduled to the research site. This research is conducted by the Department of Pediatrics, Cipto Mangunkusumo Hospital, Jakarta, Dr. Soetomo Hospital, Surabaya and PT Bio Farma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | – | –Bio-TCV group : Blood collection for long-term protection |
| Comparator | – | –Typbar group : Blood collection for long-term protection |
Who may qualify
- Ages
- 6 months to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects who previously enrolled in Phase 3 study Typhoid 0319 in Main Study I
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 (1 listed)
- History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate antibody persistence 5 years after vaccination with one dose of Vi-DT vaccine (Bio TCV), compared to PQed TCV (Typbar)
Time frame: 5 years since got vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibody Typhoid Vaccine, 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 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: opening soon, as of the sponsor's last update on 3 Jun 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernie Medise, SpA(K), M (021-4894932, bernie.medise@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate antibody persistence 5 years after vaccination with one dose of Vi-DT vaccine (Bio TCV), compared to PQed TCV (Typbar) (time frame: 5 years since got vaccination). 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 3 Jun 2025.