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

Study Overview
=================
Brief Summary
-----------------
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.

Detailed Description
-----------------
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and to Typhoid Vi polysaccharide vaccine. Involved participants aged 6 months old to 60 years old.

Official Title
-----------------
Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to Lot Consistency, Non-inferiority to PQed (Prequalified) TCV (Typhoid Conjugate Vaccine)

Conditions
-----------------
Safety Issues, Immunogenicity

Intervention / Treatment
-----------------
* Biological: Vi-DT Typhoid Conjugate Vaccine
* Biological: PQed Typhoid Conjugate Vaccine
* Biological: Vi Polysaccharide Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy. Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form. Subject/parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial. Exclusion Criteria: Subject concomitantly enrolled or scheduled to be enrolled in another trial. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axilary 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 immunosuppressants) 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 vaccinated with any vaccine within one month prior and expect to receive other vaccines within one month following vaccination except MR (Measles Rubella) vaccine. Individuals who have a previously ascertained typhoid fever by laboratory confirmation (blood culture/new rapid test) at any time. Subject planning to move from the study area before the end of study period.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects 6 months - 45 years of age: Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine Subjects 46 - 60 years of age: Randomized, observer blind, lot to lot consistency, superiority to Vi polysaccharide vaccine. Subjects 6 months - 60 years old: Randomized, observer blind, lot to lot consistency
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vi-DT TCV Batch 1<br>1 dose of 0.5 ml of Vi-DT TCV vaccine batch 1 | Biological: Vi-DT Typhoid Conjugate Vaccine<br>* 1 dose of Investigational Product<br>|
| Experimental: Vi-DT TCV Batch 2<br>1 dose of 0.5 ml of Vi-DT TCV vaccine batch 2 | Biological: Vi-DT Typhoid Conjugate Vaccine<br>* 1 dose of Investigational Product<br>|
| Experimental: Vi-DT TCV Batch 3<br>1 dose of 0.5 ml of Vi-DT TCV vaccine batch 3 | Biological: Vi-DT Typhoid Conjugate Vaccine<br>* 1 dose of Investigational Product<br>|
| Active Comparator: PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo)<br>1 dose of 0.5 ml of PQed TCV Vaccine | Biological: PQed Typhoid Conjugate Vaccine<br>* 1 dose of Active Comparator<br>|
| Active Comparator: Vi Polysaccharide Vaccine (subjects 46-60 years old)<br>1 dose of 0.5 ml of Vi Polysaccharide Vaccine | Biological: Vi Polysaccharide Vaccine<br>* 1 dose of Active Comparator<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe antibody response following vaccination | Comparison of GMT, seroconversion between each lot number of Vi-DT (Bio Farma ) vaccine in each group. | 28 days | 
| Adverse event, solicited or unsolicited | Number and percentage with at least one adverse event, solicited or unsolicited, within 30 minutes, 72 hours, 7 days, and 28 days after vaccination. | 28 days | 
| Comparison the safety and immunogenicity | Comparison of adverse events occuring until 28 days after vaccination between each lot number of Vi-DT (Bio Farma ) vaccine and PQed typhoid conjugate vaccine | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccine, Typhoid Conjugate Vaccine