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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2021-01-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Typhoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants age 6-23 months

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Observer Blinded

Study Groups

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A (Single dose)

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.

Group Type EXPERIMENTAL

Vi-DT

Intervention Type BIOLOGICAL

Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial

FluQuadri™

Intervention Type BIOLOGICAL

Manufacturer: Sanofi Pasteur Dose: 0.25 ml

\*Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding.

B (Two dose)

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.

Group Type ACTIVE_COMPARATOR

Vi-DT

Intervention Type BIOLOGICAL

Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial

C (Placebo/Comparator)

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.

Group Type PLACEBO_COMPARATOR

FluQuadri™

Intervention Type BIOLOGICAL

Manufacturer: Sanofi Pasteur Dose: 0.25 ml

\*Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding.

0.9% sodium chloride isotonic solution

Intervention Type OTHER

Manufacture: Euro-Med Inc. Dose: 0.5 mL

Interventions

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Vi-DT

Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial

Intervention Type BIOLOGICAL

FluQuadri™

Manufacturer: Sanofi Pasteur Dose: 0.25 ml

\*Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding.

Intervention Type BIOLOGICAL

0.9% sodium chloride isotonic solution

Manufacture: Euro-Med Inc. Dose: 0.5 mL

Intervention Type OTHER

Other Intervention Names

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Vi-DT typhoid conjugate vaccine

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes