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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03460405
Other study ID # Typhoid 0218
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 16, 2018
Est. completion date January 30, 2020

Study information

Verified date February 2020
Source PT Bio Farma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date January 30, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Vi-DT Vaccine
1 dose of Vi-DT Vaccine
Vi Polysaccharide Vaccine
1 dose of Vi Polysaccharide Vaccine
IPV Vaccine
1 dose of IPV Vaccine

Locations

Country Name City State
Indonesia Puskesmas Jatinegara Jakarta
Indonesia Puskesmas Senen Jakarta

Sponsors (1)

Lead Sponsor Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Adverse events after vaccination Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after 1 dose vaccination. up to 28 days
Secondary Serious adverse events after vaccination Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination 28 days
Secondary Geometric Mean Titers (GMT) Geometric Mean Titers (GMT) 28 days following immunization 28 days
Secondary Percentage of subjects with increasing antibody titer >= 4 times Percentage of subjects with increasing antibody titer >= 4 times in all subjects 28 days
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