Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: BioEâ??s Typhoid Conjugate Vaccine(Monovalent)- Single Human dose-0.5mL: 1. Dose: 0.5 mL single dose 2. Frequency: One dose only 3. Route of administration: intramuscular injection 4. T
Sponsors
Biological E Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects of either gender between >=6 months to 2. Subject or Subjectâ??s Parent(s) or LAR who after the nature of the study has been explained to them, have given written consent according to local regulatory requirements. 3. Subject or Subjectâ??s Parent(s) or LARâ??s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures; 4. Individuals in good health as determined by the outcome of medical history, physical examination based on clinical judgment of the investigator. 5. Negative to urine pregnancy test for female subjects of childbearing potential. Female of childbearing potential is defined as a pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) total hysterectomy.
Exclusion criteria
Exclusion criteria: 1. Individuals who have a previously ascertained or suspected disease caused by Salmonella typhi; 2. Individuals who have history of household contact with/and or intimate exposure to an individual with laboratory confirmed S. typhi; 3. Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines); 4. Individuals with body temperature >=100.4°F (>=38.0°C) within 3 days of intended study immunization; 5. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neurological, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease); 6. Subject or Subjectâ??s Parent(s) or LAR unwillingness or inability to understand and follow required study procedures, keep appointments, or are planning to relocate during the study period; 7. Individuals with history of any illness or any laboratory abnormality that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; 8. Subject with suspected or known history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days; 9. Subject with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time or history of receipt of anti-coagulants in the past 3 weeks; 10. History of allergy or allergic reaction to any vaccine-related component; 11. Individuals participating in any other clinical trial within 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study; 12. Women who are pregnant or breast-feeding or of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Female of childbearing potential or age is defined as a pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) total hysterectomy. 13. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Seroconversion rate as measured by proportion of subjects with anti-Vi IgG serum antibody concentrations above the threshold value. 2.Geometric mean concentrations (GMC) of anti-Vi IgG antibodies. 3.Fold increase in anti-Vi IgG antibody concentration.Timepoint: 1.at day 0 pre vaccination and at day 42 post vaccination. 2.at day 0 (pre vaccination) and at day 42 (post vaccination) 3.post-vaccination sample from pre-vaccination concentrations | — |
Secondary
| Measure | Time frame |
|---|---|
| Medically attended and/or serious adverse events (SAEs), if anyTimepoint: during the post vaccination 42 day follow up period.;Proportion of subjects with solicited adverse reactionsTimepoint: during first 30 minutes of post vaccination observation period and for subsequent 7 consecutive days (Day 0-6);Proportion of subjects with unsolicited adverse events (AEs)Timepoint: during the follow up period until day 42 of post vaccination. | — |
Countries
India
Contacts
Public ContactDr Subhash Thuluva
Biological E.Limited
Outcome results
None listed