Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: BioE’s Typhoid Conjugate Vaccine(Monovalent)- Single Human dose-0.5mL: 1. Dose: 0.5 mL single dose 2. Frequency: Single booster dose only 3. Route of administration: intramuscular inje
Sponsors
Biological ELimited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy primed children, adolescents and adults of either gender between 6 months to 45 years (both inclusive) of age, who participated in a previous phase-II/III study bearing No.BECT053. 2. Subjects who are willing to participate and who would be expected to comply with the requirements of the protocol. 3. Written voluntarily given informed consent given by the subject or subject’s parent / legally acceptable representative prospectively.
Exclusion criteria
Exclusion criteria: 1. Subjects who did not receive a single dose of Typhoid conjugate vaccine in previous study bearing No. BECT053. 2. Subjects for whom blood samples could not be collected either at baseline or at post vaccination period in the previous study bearing No. BECT053. 3. Female subjects with UPT (Urine Pregnancy Test) positive at Visit 3 (pre-booster at Day 730). 4. History of documented hypersensitivity to any component of the vaccine. 5. History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis. 6. Receipt of any other investigational intervention or blood products in the last 3 months or anticipated during the course of the study. 7. Any confirmed or suspected immunosuppressive or immune-deficient condition or receipt of systemic immunosuppressant or systemic corticosteroids in the last 3 months based on medical history and physical examination; 8. Known history of diabetes, tuberculosis, cancer, chronic kidney, heart, or liver disease, progressive neurological disorders, poorly controlled seizures, or terminal illness. 9. Any condition determined by the investigator likely to interfere with evaluation of the vaccine or to be a significant potential health risk to the child or make it unlikely that the child would complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and percentage of subjects with anti-Vi IgG antibodiesTimepoint: At or above 12, 24 and 36 months post primary vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| » Number and percentage of subjects with medically attended and/or serious adverse events (SAEs), if anyTimepoint: during the 42 days follow up period after booster vaccination.;Geometric mean concentrations of anti-Vi IgG antibodies and proportion of subjects with =4-fold rise of antibodiesTimepoint: At day 42 post booster dose;Number and percentage of subjects with anti-Vi IgG antibodiesTimepoint: At day 42 post booster dose;Number and percentage of subjects with solicited adverse reactionsTimepoint: during first 30 minutes of post booster vaccination observation period and for subsequent 7 consecutive days;Number and percentage of subjects with unsolicited adverse events (AEs)Timepoint: during the follow up period until day 42 post booster vaccination | — |
Countries
India
Contacts
Public ContactDr Kishore TSA
Biological E.Limited
Outcome results
None listed