CVIA 092Short Title: Phase 3 EuTCV Trial in Africa
- Conditions
- Typhoid feverPaediatrics
- Registration Number
- PACTR202112680671189
- Lead Sponsor
- EuBiologics Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3255
1. Male or female participants, ages 6 months to 45 years (all inclusive)
2. Healthy as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history and clinical assessment
3. The participant him/herself (or his/her guardian or LAR) is informed and consents, and signs informed consent form. If the participant is above the age of assent per local ethics committee requirements, informed assent will also be sought.
4. Participants are able to follow the requirements of clinical trial protocol and intend to remain in the area during the study period
5. Individuals of childbearing capacity: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study
Specific for children:
1. 6–36-month-olds must have a weight for height Z score of =-2 at the time of randomization
2. Infants must have been born >36 weeks gestation
3. Must have completed all age-appropriate recommended EPI vaccinations at time of randomization
-Participation in research involving another IP during the 30 days before planned first vaccination or concurrently participating in another clinical study
-History of major congenital abdominal disorders, intussusception, abdominal surgery, or other congenital disorder or presence of significant medical condition
-Clinical evidence of gastrointestinal illness and acute disease (a temporary exclusion)
-Known or suspected impairment of immunological function based on medical history and examination. Known history of immune function disorders incl immunodeficiency disease or chronic systemic steroid use, cytotoxic or immunosuppressive drugs
-Breastfeeding, pregnancy, planning pregnancy during the study, or unwilling to use adequate contraception
-History of uncontrolled coagulopathy or blood disorders
-Presence of known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease)
-Known history of administration of blood or blood-derived products in the past 90 days
-Previously ascertained or suspected disease caused by S. typhi
-Household contact with and/or intimate exposure to individual with laboratory-confirmed S. typhi
-Have received a dose of Typhoid-containing vaccine within the last 10 years
-Already immunised with any licensed vaccine within 4 weeks prior to enrolment/vaccination
-Have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid
-Known hypersensitivity to any component of the study vaccines
-Clinically significant screening laboratory value
-Acute illness, infectious disease, or fever within 3 days and/or acute illness requiring antibiotic or antiviral within past 7 days
-Not be able to comply with any of the protocol required procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity: Seroconversion rates (=4-fold rise from baseline) of anti-Vi IgG ELISA titers at 28 days after vaccination of EuTCV multi-dose vial, EuTCV single-dose vial, or Typbar TCV® (immunogenicity subset);Safety: Proportion of solicited local and systemic adverse events;<br>o Local: pain, tenderness, erythema/redness, swelling/induration, pruritus, and abscess<br>o Systemic (adapted to each age group): fever, lethargy, irritability, nausea/vomiting, arthralgia, diarrhoea, drowsiness, loss of appetite, chills, headache, fatigue, myalgia, persistent crying and acute allergic reaction.<br>;Safety: Proportion of unsolicited AEs ;Safety: Proportion of SAEs throughout the study
- Secondary Outcome Measures
Name Time Method