Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine

I

International Vaccine Institute (IVI)

Status and phase

Completed
Phase 2

Conditions

Typhoid

Treatments

Biological: FluQuadri™
Biological: Vi-DT
Other: 0.9% sodium chloride isotonic solution

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03527355
IVI T002

Details and patient eligibility

About

This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose. The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age. The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6 months apart.

Full description

This study is carried out in healthy children aged 6 to 23 months at a single site. A total of 285 participants are enrolled, 114, 114 and 57 participants are randomized to either the single dose, two-dose Vi-DT regimens or placebo/comparator group, respectively within age strata. Three age strata is 6 to less than 9 months, 9 to 12 months and 13 to 23 months. The investigators allow the 9-12 months old children to receive Measles-Mumps-Rubella (MMR) vaccine concomitantly with Vi-DT vaccine and descriptive analysis of immune response to MMR only and to MMR and Vi-DT vaccines are performed to assess the possible immunological interference with MMR vaccine.

Enrollment

285 patients

Sex

All

Ages

6 to 23 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

285 participants in 3 patient groups, including a placebo group

A (Single dose)
Experimental group
Description:
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.
Treatment:
Biological: Vi-DT
Biological: FluQuadri™
B (Two dose)
Active Comparator group
Description:
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.
Treatment:
Biological: Vi-DT
C (Placebo/Comparator)
Placebo Comparator group
Description:
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.
Treatment:
Other: 0.9% sodium chloride isotonic solution
Biological: FluQuadri™

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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