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

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Brief Title

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

Official Title

A Phase II, Randomized, Dose-scheduling, Observer-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of Vi-DT Conjugate Vaccine in 6-23-Month Old Healthy Filipino Infants and Toddlers

Brief Summary

      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.
    

Detailed 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Safety endpoints: solicited and unsolicited adverse events and serious adverse events

Secondary Outcome

 Immunogenicity Endpoints

Condition

Typhoid

Intervention

Vi-DT

Study Arms / Comparison Groups

 A (Single dose)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

285

Start Date

April 18, 2018

Completion Date

August 2020

Primary Completion Date

July 28, 2018

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
      

Gender

All

Ages

6 Months - 23 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Maria Rosario Capeding, MD, , 

Location Countries

Philippines

Location Countries

Philippines

Administrative Informations


NCT ID

NCT03527355

Organization ID

IVI T002


Responsible Party

Sponsor

Study Sponsor

International Vaccine Institute

Collaborators

 SK Bioscience Co., Ltd.

Study Sponsor

Maria Rosario Capeding, MD, Principal Investigator, Research Institute for Tropical Medicine, Metro Manila, Philippines


Verification Date

April 2020