Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III)

Summary

This is a multicenter, randomized, observer-blinded, controlled, immune equivalence study of a multi-dose (MD) formulation with 2PE preservative of SK bioscience Vi-DT compared to single dose (SD) formulation without preservative of SK bioscience Vi-DT in participant (6 months - 45 years) including safety population.

The study objectives are as follows:

* Primary objective. Demonstrate the immune equivalence as measured by anti-Vi IgG Geometric Mean Titer (GMT) of multi dose formulation against single dose formulation of Vi-DT (18-45 year age stratum), at 4 weeks after a single dose.
* Secondary objective 1. Demonstrate the immune equivalence as measured by seroconversion rates of anti-Vi IgG antibody titres of multi dose formulation against single dose formulation of Vi-DT vaccine (18-45 year age stratum) at 4 weeks after a single dose.
* Secondary objective 2. Describe safety profile in all age strata combined (age 6 months - 45 years old) and in each age stratum, at 4 weeks after a single dose of SD/MD formulation/control (Meningococcal Conjugate Vaccine).

There are total 5 scheduled visits as follows:

* Visit 1(D-7 to 0): Screening
* Visit 2(D0): Enrollment, vaccination, safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above)
* Visit 3(D7): Safety follow-up
* Visit 4(D28): Safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above)
* V5(D168): Safety follow-up

Conditions

• Typhoid

Interventions

BIOLOGICAL

Vi-DT (Multi-dose formulation)

* Manufacturer: SK bioscience Co., Ltd. * Dose formulation: 25 µg Vi polysaccharide /0.5 mL, presented in Type I glass vial (multi dose Vi-DT with preservative 2 PE) * Mode of Administration: 0.5 mL by intramuscular injection in the left anterolateral thigh or left arm deltoid region in participants below 2 years of age, less dominant arm deltoid region in age group 2 to 45 years * Storage Conditions: +2 to +8°C

BIOLOGICAL

Vi-DT (Single dose formulation)

* Manufacturer: SK bioscience Co., Ltd. * Dose formulation: 25 µg Vi polysaccharide /0.5 mL, presented in Type I glass vial (single dose Vi-DT without any preservative) * Mode of Administration: 0.5 mL by intramuscular injection in the left anterolateral thigh or left arm deltoid region in participants below 2 years of age, less dominant arm deltoid region in age group 2-45 years * Storage Conditions: +2 to +8°C

BIOLOGICAL

Control Vaccine

* For participant ≥ 1 year one dose of locally licensed Meningococcal conjugate vaccine will be administered * For participants 6 months to 1 year one dose of locally licensed Meningococcal conjugate vaccine will be administered during the study and the next dose will be provided after the study unblinding at the completion of 6 months follow up of last subject.

Sponsors & Collaborators

• SK Bioscience Co., Ltd.

  collaborator INDUSTRY

• Bill and Melinda Gates Foundation

  collaborator OTHER

• International Vaccine Institute

  lead OTHER

Principal Investigators

• Josefina C Carlos, MD · University of the East-Ramon Magsaysay Memorial Medical Center Inc.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-02-04

Primary Completion

2020-09-11

Completion

2021-01-29

Countries

• Philippines

Study Locations