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

PT Bio Farma

Status and phase: Completed; Phase 2

Conditions: Safety Issues; Immunogenicity

Treatments: Biological: Vi-DT Vaccine; Biological: Vi Polysaccharide Vaccine; Biological: IPV Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03460405

Typhoid 0218

Details and patient eligibility

About

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

Full description

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).

Enrollment: 600 patients

Sex: All

Ages: 6 months to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 For adults-adolescent-children:

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.

Exclusion Criteria for infants:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

600 participants in 6 patient groups

VI-DT vaccine (adults,adolescent)

Experimental group

Description:

1 dose of 0.5 ml Vi-DT vaccine

Treatment:

Biological: Vi-DT Vaccine

Vi polysaccharide (adults,adolescent)

Active Comparator group

Description:

1 dose of 0.5 ml Vi polysaccharide vaccine

Treatment:

Biological: Vi Polysaccharide Vaccine

VI-DT vaccine (children)

Experimental group

Description:

1 dose of 0.5 ml Vi-DT vaccine

Treatment:

Biological: Vi-DT Vaccine

Vi polysaccharide vaccine (children)

Active Comparator group

Description:

1 dose of 0.5 ml Vi polysaccharide vaccine

Treatment:

Biological: Vi Polysaccharide Vaccine

VI-DT vaccine (infants)

Experimental group

Description:

1 dose of 0.5 ml Vi-DT vaccine

Treatment:

Biological: Vi-DT Vaccine

IPV Vaccine (infants)

Active Comparator group

Description:

1 dose of 0.5 ml IPV vaccine

Treatment:

Biological: IPV Vaccine