A clinical study to assess the safety and tolerability of Typhoid conjugate vaccine of BE when administered as a single dose.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2019/07/020451
- Lead Sponsor
- Biological ELimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1770
1. Healthy subjects of either gender between =6 months to =45 years of age at the time of vaccination
2. Subject or Subject’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 Subject’s Parent(s) or LAR’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.
1. Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines);
2. Individuals with body temperature =100.4°F (=38.0°C) within 3 days of intended study immunization;
3. 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);
4. Subject or Subject’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;
5. Individuals with history of any illness or any laboratory abnormality that, in the opinion of the investigator, which might pose additional risk to the subjects due to participation in the study;
6. 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;
7. History of allergy or allergic reaction to any vaccine-related component;
8. Individuals participated/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;
9. 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.
10. Any other reason that in the opinion/judgement of the investigator may interfere with the evaluation required by the study objectives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Proportion of subjects with solicited adverse reactions. <br/ ><br>2.Proportion of subjects with unsolicited adverse events (AEs). <br/ ><br>3.Medically attended and/or serious adverse events (SAEs), if any,Timepoint: 1.during first 30 minutes of post vaccination observation period and for subsequent 7 consecutive days (Day 0-6) for any solicited adverse events captured through subject diary. <br/ ><br>2.during the follow up period until day 42 of post vaccination. <br/ ><br>3.during the post vaccination 42 days follow up period.
- Secondary Outcome Measures
Name Time Method oneTimepoint: None