Safety Issues, Immunogenicity
Conditions
Keywords
Vaccine, Typhoid Conjugate Vaccine
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.
Interventions
BIOLOGICALVi-DT Typhoid Conjugate Vaccine
1 dose of Investigational Product
BIOLOGICALPQed Typhoid Conjugate Vaccine
1 dose of Active Comparator
BIOLOGICALVi Polysaccharide Vaccine
1 dose of Active Comparator
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Investigational Product and Active Comparator was masking Number of lot was masking
Intervention 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
Eligibility
Sex/Gender
ALL
Age
6 Months to 60 Years
Healthy volunteers
Yes
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | 28 days | Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Outcome results
None listed