Typhoid Fever
Conditions
Brief summary
This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.
Interventions
BIOLOGICALEuTCV (Vi-CRM Typhoid conjugate vaccine)
Single dose, Intramuscular administration
BIOLOGICALTypbar-TCV
Single dose, Intramuscular administration
Sponsors
EuBiologics Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy participants ≥6 months and ≤45 years of age at enrolment 2. Participants/Parents/Legally Authorized Representative(LAR) willing to give written informed consent/assent to participate in the trial 3. Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study 4. Participants who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests 5. Female participants must have a negative serum (at Screening) and negative urinary (at Day 1) pregnancy test and agree to use 2 methods of contraception from dosing until 90 days after vaccination.
Exclusion criteria
1. Participants/Parents/LAR unwilling to give his/her consent/assent to participate in the trial 2. Participants concomitantly enrolled or scheduled to be enrolled in another trial 3. Children and infants with a congenital abnormality 4. Known history of immune function disorders including immunodeficiency disease, or chronic use of systemic steroids, cytotoxic or other immunosuppressive drugs 5. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception 6. History of uncontrolled coagulopathy or blood disorders 7. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the trial objectives 8. History of alcohol or substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rate | 4 weeks after vaccination of EuTCV (pooled of 3 batches)/Typbar-TCV compared to baseline |
| Proportion of Solicited local and systemic AEs | 7 days after vaccination |
| Proportion of unsolicited AEs | within 28 days after vaccination |
Countries
Philippines
Outcome results
None listed