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

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

Detailed Description
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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).

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

Conditions
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Immunogenicity, Safety Issues

Intervention / Treatment
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* Biological: Vi-DT Vaccine
* Biological: Vi Polysaccharide Vaccine
* Biological: IPV Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Subjects/Parents have been informed properly regarding the study and signed the informed consent form 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: 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, corticosteroid therapy and other immunosuppresant). 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 1 month prior and expect to receive other vaccines within 1 month following immunization. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization. History of substance abuse (Adults). Subject planning to move from the study area before the end of study period. Exclusion Criteria for infants: Subject concomitantly enrolled or scheduled to be enrolled in another trial Mother less than 18 years of age at the age of enrollment of the infant 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, corticosteroid therapy and other immunosuppresant). 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. Individuals who have previously received any vaccines against typhoid fever. Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization, except MR vaccine. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization. Subject planning to move from the study area before the end of study period.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VI-DT vaccine (adults,adolescent)<br>1 dose of 0.5 ml Vi-DT vaccine | Biological: Vi-DT Vaccine<br>* 1 dose of Vi-DT Vaccine<br>* Other names: Typhoid Conjugate Vaccine;|
| Active Comparator: Vi polysaccharide (adults,adolescent)<br>1 dose of 0.5 ml Vi polysaccharide vaccine | Biological: Vi Polysaccharide Vaccine<br>* 1 dose of Vi Polysaccharide Vaccine<br>|
| Experimental: VI-DT vaccine (children)<br>1 dose of 0.5 ml Vi-DT vaccine | Biological: Vi-DT Vaccine<br>* 1 dose of Vi-DT Vaccine<br>* Other names: Typhoid Conjugate Vaccine;|
| Active Comparator: Vi polysaccharide vaccine (children)<br>1 dose of 0.5 ml Vi polysaccharide vaccine | Biological: Vi Polysaccharide Vaccine<br>* 1 dose of Vi Polysaccharide Vaccine<br>|
| Experimental: VI-DT vaccine (infants)<br>1 dose of 0.5 ml Vi-DT vaccine | Biological: Vi-DT Vaccine<br>* 1 dose of Vi-DT Vaccine<br>* Other names: Typhoid Conjugate Vaccine;|
| Active Comparator: IPV Vaccine (infants)<br>1 dose of 0.5 ml IPV vaccine | Biological: IPV Vaccine<br>* 1 dose of IPV Vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Serious adverse events after vaccination | Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination | 28 days | 
| Geometric Mean Titers (GMT) | Geometric Mean Titers (GMT) 28 days following immunization | 28 days | 
| Percentage of subjects with increasing antibody titer >= 4 times | Percentage of subjects with increasing antibody titer >= 4 times in all subjects | 28 days |