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TYP03A Low Dose with Alum investigational vaccine

Phase 1

Typhoid Fever | Monoclonal antibody | Other |GSK plc|Last Updated: Jan 24, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment97
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05613205Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy AdultsPHASE1 COMPLETED 97Nov 28, 2022Apr 2, 2024Jan 24, 20251 Belgium
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Study Endpoints
Primary Endpoints
Number of Participants With Solicited Administration-site Events After the First Vaccination
From Day 1 to Day 7

Solicited administration site events included pain, redness, and swelling.

Number of Participants With Solicited Administration-site Events After the Second Vaccination
From Day 169 to Day 175

Solicited administration site events included pain, redness, and swelling.

Number of Participants With Solicited Systemic Events After the First Vaccination
From Day 1 to Day 7

The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), fever, headache, and myalgia (muscle pain). Fever is defined as body temperature more than or equal to (\>=) 38.0 degrees Celsius (°C).

Number of Participants With Solicited Systemic Events After the Second Vaccination
From Day 169 to Day 175

The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), fever, headache, and myalgia (muscle pain).

Number of Participants With Unsolicited Adverse Events (AEs) After the First Vaccination
From Day 1 to Day 28

An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

Number of Participants With Unsolicited Adverse Events After the Second Vaccination
From Day 169 to Day 196

An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

Number of Participants With Any Serious Adverse Events (SAEs)
From Day 1 to Day 197

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.

Number of Participants With AEs/SAEs Leading to Withdrawal From the Study
From Day 1 to Day 197

Any AEs including SAEs that lead to withdrawal from the study are considered under this outcome measure. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.

Number of Participants With SAEs Leading to Withholding Further Study Intervention Administration
From Day 1 to Day 197

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. SAEs that lead to withholding of the study intervention administration were considered under this outcome measure.

Number of Participants With AEs Leading to Withholding Further Study Intervention Administration
From Day 1 to Day 197

An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. AEs that lead to withholding of the study intervention administration were considered under this outcome measure.

Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
At Day 8 compared to Day 1 (Baseline)

Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, hematocrit, lymphocytes, monocytes, neutrophils, platelets, leukocytes. Hepatic laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and renal laboratory parameters include creatinine and blood urea. Categories reported when comparing Day 1 (baseline) and Day 8 hematological, renal and hepatic laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Range level being classified as below, within or above the normal range.

Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
At Day 176 compared to Day 169 (Baseline)

Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, hematocrit, lymphocytes, monocytes, neutrophils, platelets, leukocytes. Hepatic laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and renal laboratory parameters include creatinine and blood urea. Categories reported when comparing Day 169 (baseline) and Day 176 hematological, renal and hepatic laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Range level being classified as below, within or above the normal range.

Secondary Endpoints
Number of Participants With Any SAE
From Day 197 to Day 337
Number of Participants With AEs/SAEs Leading to Withdrawal From the Study
From Day 197 to Day 337
Geometric Mean Concentrations (GMCs) of Anti-Vi Antigen Immunoglobulin G (IgG) Antibody Concentrations
At Day 1 (pre-dose 1), Day 29, Day 169 (pre-Dose 2), Day 176 and Day 197
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Step 1a: Low dose TYP04A vaccine without AlumEXPERIMENTALParticipants received low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
Step 1b: Low dose TYP03A vaccine with AlumEXPERIMENTALParticipants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
Step 2: Full dose TYP04B vaccine without AlumEXPERIMENTALParticipants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
Step 2: Full dose TYP03B vaccine with AlumEXPERIMENTALParticipants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
Control: TYPHIM VI and BOOSTRIX vaccineACTIVE_COMPARATORParticipants received TYPHIM VI as comparator intramuscularly on Day 1, and BOOSTRIX as comparator on Day 169.
Interventions
NameTypeDescription
TYP04A Low Dose without Alum investigational vaccineBIOLOGICAL2 doses of TYP04A Low Dose without Alum investigational vaccine administered intramuscularly as a priming dose on Day 1 and a booster dose on Day 169.
TYP04B Full Dose without Alum investigational vaccineBIOLOGICAL2 doses of TYP04B Full Dose without Alum investigational vaccine administered intramuscularly as a priming dose on Day 1 and a booster dose on Day 169.
TYP03A Low Dose with Alum investigational vaccineBIOLOGICAL2 doses of TYP03A Low Dose with Alum investigational vaccine administered intramuscularly as a priming dose on Day 1 and a booster dose on Day 169.
TYP03B Full Dose with Alum investigational vaccineBIOLOGICAL2 doses of TYP03B Full Dose with Alum investigational vaccine administered intramuscularly as a priming dose on Day 1 and a booster dose on Day 169.
Sanofi Pasteur's Typhoid Vi polysaccharide vaccineBIOLOGICAL1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly, at Day 1, to participants in the control group.
GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccineBIOLOGICAL1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine administered intramuscularly, at Day 169, to participants in the control group.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants who, in the opinion of the Investigator, can and will comply with the requirements of the Protocol (e.g., completion of the diary cards, return for follow-up visits). * Written informed consent obtained from the participant prior to performance of any study specif...

Countries:Belgium
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