CVIA 092 Short Title: phase 3 EuTCV Trial in Africa

Authors
Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2021
INTERVENTION: 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 CONDITION: ; Typhoid fever ; Paediatrics Paediatrics Typhoid fever PRIMARY OUTCOME: 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 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.; Safety: Proportion of unsolicited AEs SECONDARY OUTCOME: 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) GMTs of anti‐Vi IgG 28 days after vaccination of EuTCV single‐dose vial, EuTCV multi‐dose vial, or Typbar TCV® (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) 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) Rubella IgG GMCs 28 days following vaccination with either single‐dose vial and multi‐dose vial formulations of EuTCV or Typbar TCV® (immunogenicity subset) 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. M
Epistemonikos ID: 55bf233bcb3a4fc868cfd9461a8e0b186f1da421
First added on: Aug 25, 2024