NCT03109600

Brief Summary

This study is to assess the safety of Vi-DT vaccine in adults and children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

April 18, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2018

Completed
Last Updated

March 6, 2018

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

November 1, 2016

Last Update Submit

March 4, 2018

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

  • Local reaction and systemic event after vaccination

    Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.

    28 days

Secondary Outcomes (5)

  • Adverse events after vaccination

    28 days

  • Serious adverse events after vaccination

    28 days

  • Routine laboratory evaluation that probably related to the vaccination.

    7 days

  • Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)

    28 days

  • Geometric Mean Titers (GMT) following immunization

    28 days

Study Arms (4)

Vi-DT (Bio Farma)

EXPERIMENTAL

2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine

Biological: Vi-DT (Bio Farma)

Vi polysaccharide vaccine

ACTIVE COMPARATOR

1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine

Biological: Vi polysaccharide vaccineBiological: Influenzae vaccine

Vi-DT (Bio Farma) ~ Children

EXPERIMENTAL

2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine

Biological: Vi-DT (Bio Farma)

Vi polysaccharide vaccine ~ Children

ACTIVE COMPARATOR

1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine

Biological: Vi polysaccharide vaccineBiological: Pneumococcal conjugate vaccine

Interventions

Vi-DT (Bio Farma)BIOLOGICAL

Typhoid Conjugate Vaccine

Vi-DT (Bio Farma)Vi-DT (Bio Farma) ~ Children
Vi polysaccharide vaccineBIOLOGICAL

Vi polysaccharide vaccine

Vi polysaccharide vaccineVi polysaccharide vaccine ~ Children
Influenzae vaccineBIOLOGICAL

1 dose of Influenzae vaccine

Vi polysaccharide vaccine
Pneumococcal conjugate vaccineBIOLOGICAL

1 dose of Pneumococcal conjugate Vaccine

Vi polysaccharide vaccine ~ Children

Eligibility Criteria

Age2 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy
  • Subjects/Parents have been informed properly regarding the study and signed the informed consent form
  • Subject/Parents will commit to comply with the instructions of the investigator and the schedule of the trial

You may not qualify if:

  • Subject concomitantly enrolled or scheduled to be enrolled in another trial
  • Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C )
  • Known history of allergy to any component of the vaccines
  • History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
  • Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks).
  • Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
  • Pregnancy \& lactation (Adults)
  • Individuals who have previously received any vaccines against typhoid fever.
  • Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
  • Individuals who have a previously ascertained typhoid fever.
  • History of alcohol or substance abuse.
  • Subject planning to move from the study area before the end of study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Puskesmas Jatinegara

Jakarta, DKI Jaya, Indonesia

Location

Jatinegara Primary Health Center

Jakarta, Indonesia

Location

MeSH Terms

Interventions

Vi polysaccharide vaccine, typhoidPneumococcal Vaccines

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Bernie Endyarni, MD

    Faculty of Medicine, University of Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

April 12, 2017

Study Start

April 18, 2017

Primary Completion

September 28, 2017

Study Completion

February 19, 2018

Last Updated

March 6, 2018

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

ID(2)