Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to lot consistency, Non-inferiority to PQed TCV and Typhoid Vi Polysaccharide Vaccine

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
RS Cipto Mangunkusumo Jakarta, RS Dr. Soetomo Surabaya, RS Sanglah Denpasar
No Registry
INA-MZXONZG
Tanggal Input Registry : 28-01-2020

10-02-2020
To evaluate seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants.
- To describe antibody response following vaccination with one dose of Vi-DT in adults, children and infants for each lot. - To evaluate the percentage of subjects that achieve anti-Vi IgG levels equal to or above predefined threshold values. - To assess the safety following vaccination with one dose of Vi-DT in adult, children and infants. - To compare the safety and immunogenicity of Vi-DT (Bio Farma) to PQed typhoid conjugate vaccine in each age group (6 months-45 years old). - To compare the safety and immunogenicity between three lot of Vi-DT (Bio Farma). - To compare the safety and immunogenicity of Vi-DT (Bio Farma) to Vi polysaccharide vaccine in group 46-60 years old. - To evaluate the safety and immunogenicity of Vi-DT co-administered with MR vaccine in subject ≥ 9 months -23 months old (sub study).
 
Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to lot consistency, Non-inferiority to PQed TCV and Typhoid Vi Polysaccharide Vaccine
Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to lot consistency, Non-inferiority to PQed TCV and Typhoid Vi Polysaccharide Vaccine
Eksperimental
Vaksin Tifoid Konjugat (Vi-DT)
3071
 

Inclusion Criteria:

1. Healthy. 2. Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form. 3. Subject/parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial. 2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) 3. Known history of allergy to any component of the vaccines. 4. History of uncontrolled coagulopathy or blood disorders contraindicating injection. 5. 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 immunosuppresant). 6. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. 7. Pregnancy & lactation (Adults). Based on test pack. 8. Individuals who have previously received any vaccines against typhoid fever. 9. Subjects already vaccinated with any vaccine within one month prior and expect to receive other vaccines within one month following vaccination except MR vaccine. 10. Individuals who have a previously ascertained typhoid fever by laboratory confirmation (blood culture/new rapid test) at any time. 11. Subject planning to move from the study area before the end of study period.
 
RS Sanglah: 3021/UN14.2.2.VII.14/LP/2019, RSCM: KET-1231/UN2.F1/ETIK/PPM.00.02/2019, UNAIR: No. 13/EC/KEPK/FKUA/2020
NA
RSCM: No.RG.01.06.321.01.20.0161; RS Dr. Soetomo: RG.01.06.321.01.20.0162, RS Sanglah: RG.01.06.321.01.20.0163
Typhoid0319
dr. Bernie Endyarni Medise, SpA(K), MPH, Dr. Dominicus Husada, dr., SpA(K), Dr. I Gusti Ayu Trisna Windiani,dr., SpA(K)