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

Safety Issues Clinical Trial

Official title:

Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian Adults, Adolescents, Children and Infants (Phase II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03460405
• Other study ID #: Typhoid 0218
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Immunogenicity
• Safety Issues
• Typhoid Fever

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