Long-Term Protection of Vi Antibodies Induced by Bio TCV in Indonesian Population Compared to PQed TCV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Antibody Typhoid Vaccine. Basic parameters: 6 months — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines (Bio TCV) in Indonesian Population Compared to PQed TCV
Overview
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.
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Indonesia · 1 center
- Department of Child Health Dr. Soetomo Hospital/School of Medicine, Airlangga University, — Jakarta
Identifiers
NCT: NCT06921460 · Typhoid-0424