Typhoid fever Paediatrics
Conditions
Interventions
EuTCV is Vi polysaccharide of Salmonella typhi Ty2 conjugated to CRM197 non preservative
EuTCV is Vi polysaccharide of Salmonella typhi Ty2 conjugated to CRM197 with preservative
Typbar TCV
Sponsors
EuBiologics Co Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 unsolicited AEs ;Safety: Proportion of SAEs throughout the study;Safety: Proportion of solicited local and systemic adverse events; o Local: pain, tenderness, erythema/redness, swelling/induration, pruritus, and abscess 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| GMTs of anti-Vi IgG 28 days after vaccination of EuTCV single-dose vial, EuTCV multi-dose vial, or Typbar TCV® (immunogenicity subset);GMTs and GMFR from baseline of Anti-Vi serum IgG at 180 days post-vaccination either multi-dose and single-dose formulations of EuTCV or Typbar TCV® (immunogenicity subset) ;GMTs of anti-Vi ELISA 28 days following a single dose of multi-dose vial EuTCV for the assessment of consistency of response across three lots of vaccine (immunogenicity subset) ;Percentage of participants with measles IgG seroconversion by ELISA 28 days following vaccination with either single-dose vial and multi-dose vial formulations of EuTCV or Typbar TCV®. (Measles seroconversion in initially seronegative infants will be defined as concentrations =200 mlU/mL) (immunogenicity subset) ;Percentage of participants with rubella IgG seroconversion by ELISA 28 days following vaccination with either single-dose vial and multi-dose vial formulations of EuTCV or Typbar TCV®. (Rubella seroconversion in initially seronegative infants will be defined as concentrations =10 lU/mL) (immunogenicity subset) ;Percentage of participants with yellow fever neutralizing antibody seroconversion 28 days following vaccination with either single-dose vial and multi-dose vial formulations of EuTCV or Typbar TCV® (YFV seroconversion is defined as a reciprocal 50% plaque reduction neutralization titer (PRNT50) of =10 among those participants negative (PRNT50< 10) at baseline) (immunogenicity subset) ;Measles IgG GMC 28 days following vaccination with either single-dose vial and multi-dose vial formulations of EuTCV or Typbar TCV® (immunogenicity subset) ;Rubella IgG GMCs 28 days following vaccination with either single-dose vial and multi-dose vial formulations of EuTCV or Typbar TCV® (immunogenicity subset) | — |
Countries
Kenya, Senegal
Contacts
Public ContactNiles ;Howard Eaton;Her
Clinical Operations Specialist and Clinical Research Manager;Sponsor
Outcome results
None listed