Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2020-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

NCT03109600

Safety Issues

COMPLETED PHASE1

Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)

NCT04051268

Safety Issues Immunogenicity

COMPLETED PHASE3

Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian

NCT04741828

Vaccine

COMPLETED PHASE2/PHASE3

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

NCT04204096

Typhoid

COMPLETED PHASE3

Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants

NCT06344065

Healthy Volunteers

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To describe the safety of this vaccine following one dose immunization in adults, adolescent, children and infants.

To assess immunogenicity following one dose of Vi-DT vaccine immunization. To compare the safety and immunogenicity of Vi-DT to Vi polysaccharide vaccine in adults, adolescents, and children groups.

To compare the safety and immunogenicity of Vi-DT to IPV vaccine in infants groups.

Kinetics of Vi-specific IgG antibodies up to 6 months and 1 year after administration of 1 dose of vaccine.

To evaluate the safety and immunogenicity of Vi-DT co-administered with MR vaccine in infants (≥ 9months -23 months old).

To evaluate the safety and immunogenicity of MR vaccine co-administered with Vi-DT vaccine in infants (≥ 9months -23 months old).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Safety Issues Immunogenicity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subject aged 2 - 40 years old:

Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine.

Subject aged 6-23 months old:

Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Subject aged 2 - 40 years old:

Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine.

Subject 6-23 months old:

Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VI-DT vaccine (adults,adolescent)

1 dose of 0.5 ml Vi-DT vaccine

Group Type EXPERIMENTAL

Vi-DT Vaccine

Intervention Type BIOLOGICAL

1 dose of Vi-DT Vaccine

Vi polysaccharide (adults,adolescent)

1 dose of 0.5 ml Vi polysaccharide vaccine

Group Type ACTIVE_COMPARATOR

Vi Polysaccharide Vaccine

Intervention Type BIOLOGICAL

1 dose of Vi Polysaccharide Vaccine

VI-DT vaccine (children)

1 dose of 0.5 ml Vi-DT vaccine

Group Type EXPERIMENTAL

Vi-DT Vaccine

Intervention Type BIOLOGICAL

1 dose of Vi-DT Vaccine

Vi polysaccharide vaccine (children)

1 dose of 0.5 ml Vi polysaccharide vaccine

Group Type ACTIVE_COMPARATOR

Vi Polysaccharide Vaccine

Intervention Type BIOLOGICAL

1 dose of Vi Polysaccharide Vaccine

VI-DT vaccine (infants)

1 dose of 0.5 ml Vi-DT vaccine

Group Type EXPERIMENTAL

Vi-DT Vaccine

Intervention Type BIOLOGICAL

1 dose of Vi-DT Vaccine

IPV Vaccine (infants)

1 dose of 0.5 ml IPV vaccine

Group Type ACTIVE_COMPARATOR

IPV Vaccine

Intervention Type BIOLOGICAL

1 dose of IPV Vaccine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vi-DT Vaccine

1 dose of Vi-DT Vaccine

Intervention Type BIOLOGICAL

Vi Polysaccharide Vaccine

1 dose of Vi Polysaccharide Vaccine

Intervention Type BIOLOGICAL

IPV Vaccine

1 dose of IPV Vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Typhoid Conjugate Vaccine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Healthy
2. Subjects/Parents have been informed properly regarding the study and signed the informed consent form
3. Subject/parents/legal guardians will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial
2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
3. Known history of allergy to any component of the vaccines
4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
5. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, corticosteroid therapy and other immunosuppresant).
6. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
7. Pregnancy \& lactation (Adults)
8. Individuals who have previously received any vaccines against typhoid fever.
9. Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization.
10. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
11. History of substance abuse (Adults).
12. Subject planning to move from the study area before the end of study period.

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial
2. Mother less than 18 years of age at the age of enrollment of the infant
3. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
4. Known history of allergy to any component of the vaccines
5. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
6. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, corticosteroid therapy and other immunosuppresant).
7. Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.
8. Individuals who have previously received any vaccines against typhoid fever.
9. Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization, except MR vaccine.
10. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
11. Subject planning to move from the study area before the end of study period.

Minimum Eligible Age

6 Months

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes