Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine
Typhoid
About this trial
This is an interventional prevention trial for Typhoid focused on measuring Typhoid, Vi-DT, Conjugate vaccine, First in human, New vaccine
Eligibility Criteria
Inclusion Criteria:
- Healthy infants and children 6-23 months of age at enrollment as determined by medical history, physical examination and clinical judgment of the investigator
- Birth weight ≥ 2500 g
- ≥ 37 weeks of pregnancy or judge to be full-term by the midwife or birth attendant
- Parents aged 18 years and above and legal guardians aged 21 years and above as per the legal authorization in the Philippines, who have voluntarily given informed consent
- Parents/ legal guardians willing to follow the study procedures of the study and available for the entire duration of the study
Exclusion Criteria:
- Child with a congenital abnormality
- Subject with abnormal routine biological values at screening
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Acute illness, in particular infectious disease or fever (axillary temperature ≥37.5°C), within three days prior to enrolment and vaccination
- Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (>20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
- Child with a previously ascertained or suspected disease caused by S. typhi
- Child who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi
- Known history or allergy to vaccines or other medications
- Know history of allergy to eggs, chicken protein, neomycin and formaldehyde
- History of uncontrolled coagulopathy or blood disorders
- Mother has known HIV infection or other immune function disorders
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the subject and interfere with the assessment of the study objectives
- Child whose parents or legal guardian planning to move from the study area before the end of study period
Sites / Locations
- Research Institute for Tropical Medicine(RITM)
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
A (Single dose)
B (Two dose)
C (Placebo/Comparator)
One dose of Vi-DT (Typhoid conjugate vaccine) 25 µg 0.5 mL is administrated intramuscularly at first dost (Day 0). One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Week 24). One booster dose of Vi-DT 0.5 mL is administrated 2 years apart (Week 96). MMR for age group at 9-12 months.
Two doses of Vi-DT (Typhoid conjugate vaccine) 25 µg 0.5 mL is administrated intramuscularly 6 months apart (Day 0 and Day 168 (Week 24)). MMR for age group at 9-12 months.
One dose of Placebo (0.9% sodium chloride isotonic solution) 0.5 mL is administrated intramuscularly at first dost (Day 0). One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Day 168; Week 24). MMR for age group at 9-12 months.