Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
- Conditions
- Safety IssuesImmunogenicity
- Interventions
- Biological: Vi-DT Typhoid Conjugate VaccineBiological: PQed Typhoid Conjugate VaccineBiological: Vi Polysaccharide Vaccine
- Registration Number
- NCT04051268
- Lead Sponsor
- PT Bio Farma
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3071
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vi-DT TCV Batch 3 Vi-DT Typhoid Conjugate Vaccine 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 3 PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo) PQed Typhoid Conjugate Vaccine 1 dose of 0.5 ml of PQed TCV Vaccine Vi-DT TCV Batch 2 Vi-DT Typhoid Conjugate Vaccine 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 2 Vi Polysaccharide Vaccine (subjects 46-60 years old) Vi Polysaccharide Vaccine 1 dose of 0.5 ml of Vi Polysaccharide Vaccine Vi-DT TCV Batch 1 Vi-DT Typhoid Conjugate Vaccine 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 1
- Primary Outcome Measures
Name Time Method Immunogenicity 28 days Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants.
- Secondary Outcome Measures
Name Time Method Describe antibody response following vaccination 28 days Comparison of GMT, seroconversion between each lot number of Vi-DT (Bio Farma ) vaccine in each group.
Adverse event, solicited or unsolicited 28 days Number and percentage with at least one adverse event, solicited or unsolicited, within 30 minutes, 72 hours, 7 days, and 28 days after vaccination.
Comparison the safety and immunogenicity 28 days 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
Trial Locations
- Locations (1)
Jatinegara Primary Health Care
🇮🇩Jakarta, Jakart, Indonesia