Clinical trial NCT04051268: Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Safety Issues
Immunogenicity
Keywords: Vaccine
Typhoid Conjugate Vaccine
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2019-08-09
Enrollment: 3071
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Immunogenicity
timeFrame: 28 days
Secondary outcomes:
measure: Describe antibody response following vaccination
timeFrame: 28 days
measure: Adverse event, solicited or unsolicited
timeFrame: 28 days
measure: Comparison the safety and immunogenicity
timeFrame: 28 days
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Jatinegara Primary Health Care
state: Jakart
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Bernie E Medise, MD
role: PRINCIPAL_INVESTIGATOR
References: