Recent Updates
Recently added Catalysts

Typhoid Vi Polysaccharide Vaccine

Phase 3

Meningococcal Disease | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Mar 11, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment552

FDA Designations

No designations recorded

Clinical trial landscape

Typhoid Vi Polysaccharide Vaccine · 1 trial · 6 indications

Phase 3 1
NCT01466387A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in AdultsMeningococcal Disease
COMPLETED552 Analytics
PHASE3COMPLETED
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
Meningococcal DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean Anti-typhoid Vi Antibody Concentrations
Baseline and 1 month postvaccination (day 29).

Assessment was made to demonstrate the non-inferiority of the geometric mean anti-typhoid Vi antibody concentrations, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.

Geometric Mean Anti-Yellow Fever Antibody Titer
Baseline and 1 month postvaccination (day 29).

Assessment was made to demonstrate the non-inferiority of the geometric mean anti-yellow fever antibody titers, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.

Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers
Baseline and 1 month post last vaccination (day 57).

Assessment was made to demonstrate the non-inferiority of the geometric mean anti-Japanese encephalitis neutralizing antibody titers, 28 days after the vaccination of the second dose of Japanese Encephalitis vaccine and third dose of the rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.

Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration
Baseline and 1 month post last vaccination (day 57).

Assessment was made to demonstrate the non-inferiority of the geometric mean anti-rabies virus neutralizing antibody concentrations, 28 days after the vaccination of the second dose of Japanese encephalitis vaccine and third dose of rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.

Secondary Endpoints

Percentages Of Subjects With Anti-YF Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of Typhoid Vi Polysaccharide And Yellow Fever, Concomitantly With MenACWY-CRM197 Or Given Alone
Baseline and 1 month postvaccination (day 29).
Percentages Of Subjects With Anti-JE Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies, Given Concomitantly With MenACWY-CRM197 Or Alone
Baseline and 1 month post last vaccination (day 57).
Percentages Of Subjects With Anti-Rabies Virus Antibody Concentrations ≥ 0.5 IU/mL 28 Days After the Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies Virus, Given Concomitantly With MenACWY-CRM197 Or Alone
Baseline and 1 month post last vaccination (day 57).
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
TF+YFACTIVE_COMPARATORSubjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
TF + YF + MenACWY-CRM197ACTIVE_COMPARATORSubjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
JE + RabiesACTIVE_COMPARATORSubjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
JE + Rab + MenACWY-CRM197ACTIVE_COMPARATORSubjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
RabiesACTIVE_COMPARATORSubjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
MenACWY-CRM197 (Combined)ACTIVE_COMPARATORSubjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.

Interventions

NameTypeDescription
Typhoid Vi Polysaccharide VaccineBIOLOGICALOne dose of typhoid Vi polysaccharide vaccine.
Yellow Fever VaccineBIOLOGICALOne dose of yellow fever vaccine.
Japanese Encephalitis VaccineBIOLOGICALTwo doses of Japanese Encephalitis Vaccine.
Rabies VaccineBIOLOGICALThree doses of Rabies vaccine.
MenACWY-CRM VaccineBIOLOGICALOne dose of MenACWY-CRM vaccine.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: Female and male subjects who must be healthy and must be: 1. Between 18 and 60 years of age inclusive and who have given their written informed consent; 2. Available for all visits and telephone calls scheduled for the study; 3. In good health as determined by medical history, ...

Countries:CzechiaGermany
Unlock Eligibility Criteria

Frequently asked questions about Typhoid Vi Polysaccharide Vaccine

What is Typhoid Vi Polysaccharide Vaccine used for?

Typhoid Vi Polysaccharide Vaccine is an investigational vaccine being studied for use in preventing meningococcal disease, typhoid, yellow fever, rabies, and Japanese encephalitis. It is being evaluated in adults aged 18 years and older. The vaccine is currently in Phase 3 clinical development and is not yet approved.

Who makes Typhoid Vi Polysaccharide Vaccine?

Typhoid Vi Polysaccharide Vaccine is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity. As of the latest data, the vaccine is in Phase 3 development.

What phase is Typhoid Vi Polysaccharide Vaccine in?

Typhoid Vi Polysaccharide Vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 552 participants, to assess its safety and immunogenicity.

What clinical trials is Typhoid Vi Polysaccharide Vaccine in?

Typhoid Vi Polysaccharide Vaccine has one completed Phase 3 trial, NCT01466387. This open-label, randomized, active-controlled study evaluated the safety and immunogenicity of select travel vaccines when administered concomitantly with MenACWY in adults. The trial enrolled 552 participants in Czechia and Germany.

Is Typhoid Vi Polysaccharide Vaccine a monoclonal antibody?

No, Typhoid Vi Polysaccharide Vaccine is not a monoclonal antibody. It is classified as a vaccine, specifically a Vi polysaccharide vaccine. The drug is being developed for infectious disease indications, including meningococcal disease and typhoid.