Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian adults, adolescents, children and infants (Phase II)

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
RSCM/UI
No Registry
INA-35ST1PS
Tanggal Input Registry : 12-07-2018

16-07-2018
• Number and percentage of infants with at least one adverse event (local reaction or systemic event), solicited and/or unsolicited within 30 minutes, 24 hours, 48 hours, 72 hours, 7 days and 28 days after vaccination. • Number and percentage of infants with seroconversion defined as 4-fold increase in antibody titer 28 days after vaccination compared to baseline
Safety: • Number and percentage of adults, adolescents and children with at least one adverse event, solicited or unsolicited, within 30 minutes, 72hours and 28 days after vaccination. • Number and percentage of subjects with serious adverse event from inclusion until 28 days after vaccination • Comparison of safety data between Vi-DT and Vi Polysacharride/Inactivated Poliomyelitis Vaccine groups. Immunogenicity: Assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT) with Vi Polysaccharide vaccine using the following criteria: • Number and percentage of adults, adolescents and children with seroconversion defined as  4-fold increase in antibody titer of anti-Vi IgG one month after vaccination compared to baseline. • Geometric Mean Titre of anti-Vi IgG in all groups in each serology schedule. • Comparison of seroconvergence defined as percentage of subjects with increasing anti-Vi IgG ≥ 4 times between Vi-DT and Vi Polysscharride in each age group. • The anti-Vi IgG antibody kinetic at 24 weeks and 48 weeks after primary dose vaccination in all groups. • Serological response to Measles vaccine in infants group (≥ 9 months -23 months). Percentage of subjects with anti Measles IgG titer 8 (1/dil) 28 days after one dose of MR vaccine, GMT, percentage of infants with increasing antibody titer  4 times and/or percentage of infants with transition of seronegative to seropositive. • Serological response to Rubella vaccine in infants group (≥ 9 months -23 months). Percentage of subjects with anti Rubella IgG titer 11 IU/mL 28 days after one dose of MR vaccine, GMT, percentage of infants with increasing antibody titer  4 times and/or percentage of infants with transition of seronegative to seropositive.
 
Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian adults, adolescents, children and infants (Phase II)
Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian adults, adolescents, children and infants (Phase II)
Observasional
1 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine
600
 

Inclusion Criteria:

1. Healthy. 2. Subjects/Parents have been informed properly regarding the study and signed the informed consent form. 3. Subject/parents/legal guardians 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 intramuscular 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). 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. 10. Individuals who have a previously ascertained typhoid fever by laboratory confirmation (blood culture/new rapid test) at any time. 11. History of substance abuse (Adults). 12. Subject planning to move from the study area before the end of study period.
 
0276/UN2.F1/ETIK/2018
NA
B-PN.01.06.323.3.05.18.2344
Typhoid0218
Bernie Endyarni Medise, dr., SpA(K), MPH.