A Phase 1 interventional study of TYP04A Low Dose without Alum investigational vaccine and TYP04B Full Dose without Alum investigational vaccine in Typhoid Fever, sponsored by GlaxoSmithKline. Completed at 1 site in Belgium. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Prevention
A bivalent Typhoid and Paratyphoid A conjugate investigational vaccine aimed to prevent both typhoid and paratyphoid enteric fever in infants and older age groups has been developed by GlaxoSmithKline (GSK).
The purpose of this first-time-in-human study is to evaluate the safety and immunogenicity profile of a low and a full dose of the investigational vaccine, formulated with or without adjuvant, administered in 2 doses, 24 weeks apart, in healthy adults 18 to 50 years of age in Europe.
77 studies on the registry are indexed under Typhoid Fever; 10 are open to participants now.
This study's enrollment of 97 is below the median of 146 across 66 interventional studies indexed under Typhoid Fever.
Browse Typhoid Fever studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female participants of childbearing potential may be enrolled in the study if the participant:
Exclusion Criteria:
Medical conditions
Acute* or chronic illness, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
*Participants with a minor illness (such as mild diarrhoea or mild upper respiratory infection) without fever may be enrolled at the discretion of the Investigator.
Any clinically significant* haematological and/or biochemical laboratory abnormality.
*The Investigator should use his/her clinical judgement to decide which abnormalities are clinically significant.
Prior/Concomitant therapy
A vaccine not foreseen by the study protocol administered during the period starting at -14 days before the first dose (-21 days in the case of live vaccines) and ending 28 days after the last dose of study intervention administration*, with the exception of flu and COVID-19 vaccines, administered during the period starting at 7 days before and 7 days after each dose (14 days before and 14 days after in case of live vaccines).
*In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organised by public health authorities outside the routine immunisation programme, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. When regulations allow, the recommended time intervals for administration of these vaccines are at least 7 days before or 7 days after (at least 14 days before or 14 days after in case of live vaccines) each dose of study intervention administration.
Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug/invasive medical device).
Other exclusions
History of travel to countries of Asia that are considered endemic* for enteric fever in the last 3 years.
*this also includes travel during study duration.
Participants received low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
Biological: TYP04A Low Dose without Alum investigational vaccine
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
Biological: TYP03A Low Dose with Alum investigational vaccine
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
Biological: TYP04B Full Dose without Alum investigational vaccine
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
Biological: TYP03B Full Dose with Alum investigational vaccine
Participants received TYPHIM VI as comparator intramuscularly on Day 1, and BOOSTRIX as comparator on Day 169.
Biological: Sanofi Pasteur's Typhoid Vi polysaccharide vaccine · Biological: GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine
2 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.
Also known as: Typhoid and Paratyphoid A conjugate low dose without adjuvant vaccine
2 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.
Also known as: Typhoid and Paratyphoid A conjugate full dose without adjuvant vaccine
2 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.
Also known as: Adjuvanted Typhoid and Paratyphoid A conjugate low dose vaccine
2 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.
Also known as: Adjuvanted Typhoid and Paratyphoid A conjugate full dose vaccine
1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly, at Day 1, to participants in the control group.
Also known as: TYPHIM VI
Drug page: Boostrix
1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine administered intramuscularly, at Day 169, to participants in the control group.
Also known as: BOOSTRIX
Number of Participants With Solicited Administration-site Events After the First Vaccination
Solicited administration site events included pain, redness, and swelling.
Time frame: From Day 1 to Day 7
Number of Participants With Solicited Administration-site Events After the Second Vaccination
Solicited administration site events included pain, redness, and swelling.
Time frame: From Day 169 to Day 175
Number of Participants With Solicited Systemic Events After the First Vaccination
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).
Time frame: From Day 1 to Day 7
Number of Participants With Solicited Systemic Events After the Second Vaccination
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), fever, headache, and myalgia (muscle pain).
Time frame: From Day 169 to Day 175
Number of Participants With Unsolicited Adverse Events (AEs) After the First Vaccination
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.
Time frame: From Day 1 to Day 28
Number of Participants With Unsolicited Adverse Events After the Second Vaccination
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.
Time frame: From Day 169 to Day 196
Number of Participants With Any Serious Adverse Events (SAEs)
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.
Time frame: From Day 1 to Day 197
Number of Participants With AEs/SAEs Leading to Withdrawal From the Study
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.
Time frame: From Day 1 to Day 197
Number of Participants With SAEs Leading to Withholding Further Study Intervention Administration
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.
Time frame: From Day 1 to Day 197
Number of Participants With AEs Leading to Withholding Further Study Intervention Administration
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.
Time frame: From Day 1 to Day 197
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
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.
Time frame: At Day 8 compared to Day 1 (Baseline)
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
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.
Time frame: At Day 176 compared to Day 169 (Baseline)
Number of Participants With Any SAE
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.
Time frame: From Day 197 to Day 337
Number of Participants With AEs/SAEs Leading to Withdrawal From the Study
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.
Time frame: From Day 197 to Day 337
Geometric Mean Concentrations (GMCs) of Anti-Vi Antigen Immunoglobulin G (IgG) Antibody Concentrations
Anti-Vi specific IgG antibodies were measured by an anti-Vi IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit. Blood samples were collected at specified timepoints.
Time frame: At Day 1 (pre-dose 1), Day 29, Day 169 (pre-Dose 2), Day 176 and Day 197
Geometric Mean Ratio (GMR) for Anti-Vi Antigen IgG Antibody Concentrations
Anti-Vi specific IgG antibodies were measured by an anti-Vi IgG ELISA kit. Blood samples were collected at specified timepoints. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Time frame: At Day 29, Day 169, Day 176, and Day 197 compared to Day 1 (baseline)
GMR for Anti-Vi Antigen IgG Antibody Concentrations
Anti-Vi specific IgG antibodies were measured by an anti-Vi IgG ELISA kit. Blood samples were collected at specified timepoints. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Time frame: At Day 176 and Day 197 compared to Day 169 (baseline)
GMC of Anti-O:2 IgG Antibody Concentrations
Anti-O:2 IgG antibodies in serum were measured by an ELISA assay. Blood samples were collected at specified timepoints.
Time frame: At Day 1 (pre-dose 1), Day 29, Day 169 (pre-dose 2), Day 176 and Day 197
GMR for Anti-O:2 IgG Antibody Concentrations
Anti-O:2 IgG antibodies in serum were measured by an ELISA assay. Blood samples were collected at specified timepoints. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Time frame: At Day 29, Day 169, Day 176, and Day 197 compared to Day 1 (baseline)
GMR for Anti-O:2 IgG Antibody Concentrations
Anti-O:2 IgG antibodies in serum were measured by an ELISA assay. Blood samples were collected at specified timepoint. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Time frame: At Day 176 and Day 197 compared to Day 169 (baseline)
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Blood samples were collected at specified timepoint for each component as measured by ELISA.
Time frame: At Day 1, Day 29, Day 169, Day 176 and Day 197
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations >= 2.0 µg/mL
Blood samples were collected at specified timepoint for each component as measured by ELISA.
Time frame: At Day 1, Day 29, Day 169, Day 176 and Day 197
Number of Participants With at Least 4-fold Increase in Anti-O:2 IgG Antibody Concentrations
Blood samples were collected at specified timepoint for each component as measured by ELISA. 4-fold increase was defined as 4 times the baseline value of anti-O:2 IgG antibody concentrations.
Time frame: At Day 29, Day 169, Day 176 and Day 197 compared to Day 1 (baseline)
| Milestone | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Started | 12 | 12 | 24 | 24 | 24 |
| Completed | 12 | 12 | 22 | 22 | 24 |
| Not completed | 0 | 0 | 2 | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 1 | 0 |
Solicited administration site events included pain, redness, and swelling.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Pain | 3 | 11 | 20 | 22 | 17 |
| Redness | 1 | 0 | 1 | 1 | 0 |
| Swelling | 1 | 0 | 1 | 1 | 1 |
Solicited administration site events included pain, redness, and swelling.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Pain | 6 | 6 | 20 | 19 | 13 |
| Redness | 1 | 0 | 0 | 0 | 1 |
| Swelling | 1 | 0 | 2 | 1 | 0 |
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).
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Arthralgia | 1 | 3 | 2 | 2 | 2 |
| Fatigue | 4 | 3 | 9 | 12 | 11 |
| Fever | 0 | 0 | 0 | 1 | 0 |
| Headache | 5 | 5 | 10 | 6 | 11 |
| Myalgia | 3 | 3 | 7 | 15 | 9 |
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), fever, headache, and myalgia (muscle pain).
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Arthralgia | 0 | 1 | 1 | 2 | 3 |
| Fatigue | 1 | 3 | 6 | 9 | 9 |
| Fever | 0 | 0 | 0 | 0 | 0 |
| Headache | 2 | 3 | 9 | 9 | 9 |
| Myalgia | 3 | 3 | 9 | 9 | 9 |
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.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Number of Participants With Unsolicited Adverse Events (AEs) After the First Vaccination | 7 | 9 | 15 | 12 | 14 |
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.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Number of Participants With Unsolicited Adverse Events After the Second Vaccination | 1 | 2 | 11 | 8 | 4 |
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.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Number of Participants With Any Serious Adverse Events (SAEs) | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Number of Participants With AEs/SAEs Leading to Withdrawal From the Study | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Number of Participants With SAEs Leading to Withholding Further Study Intervention Administration | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Number of Participants With AEs Leading to Withholding Further Study Intervention Administration | 0 | 1 | 1 | 0 | 1 |
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.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| ALT-Below -Below | 0 | 0 | 0 | 0 | 0 |
| ALT-Within-Below | 0 | 0 | 0 | 0 | 0 |
| ALT-Above-Below | 0 | 0 | 0 | 0 | 0 |
| ALT-Below-Within | 0 | 0 | 0 | 0 | 0 |
| ALT-Within-Within | 11 | 11 | 23 | 23 | 24 |
| ALT-Above-Within | 0 | 0 | 0 | 1 | 0 |
| ALT-Below-Above | 0 | 0 | 0 | 0 | 0 |
| ALT-Within-Above | 1 | 0 | 0 | 0 | 0 |
| ALT-Above-Above | 0 | 1 | 0 | 0 | 0 |
| AST-Below-Below | 0 | 0 | 0 | 0 | 0 |
| AST-Within-Below | 0 | 0 | 0 | 0 | 0 |
| AST-Above-Below | 0 | 0 | 0 | 0 | 0 |
| AST-Below-Within | 0 | 0 | 0 | 0 | 0 |
| AST-Within-Within | 12 | 12 | 23 | 22 | 23 |
| AST-Above-Within | 0 | 0 | 0 | 2 | 1 |
| AST-Below-Above | 0 | 0 | 0 | 0 | 0 |
| AST-Within-Above | 0 | 0 | 0 | 0 | 0 |
| AST-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Creatinine-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Creatinine-Within-Below | 0 | 1 | 0 | 0 | 0 |
| Creatinine-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Creatinine-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Creatinine-Within-Within | 11 | 10 | 21 | 22 | 20 |
| Creatinine-Above-Within | 0 | 0 | 2 | 2 | 1 |
| Creatinine-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Creatinine-Within-Above | 1 | 0 | 0 | 0 | 0 |
| Creatinine-Above-Above | 0 | 1 | 0 | 0 | 3 |
| Blood urea-Below-Below | 0 | 0 | 1 | 1 | 0 |
| Blood urea-Within-Below | 0 | 1 | 2 | 0 | 0 |
| Blood urea-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Blood urea-Below-Within | 1 | 1 | 0 | 3 | 0 |
| Blood urea-Within-Within | 11 | 10 | 20 | 20 | 24 |
| Blood urea-Above-Within | 0 | 0 | 0 | 0 | 0 |
| Blood urea-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Blood urea-Within-Above | 0 | 0 | 0 | 0 | 0 |
| Blood urea-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Basophils-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Basophils-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Basophils-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Basophils-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Basophils-Within-Within | 12 | 10 | 23 | 24 | 24 |
| Basophils-Above-Within | 0 | 0 | 0 | 0 | 0 |
| Basophils-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Basophils-Within-Above | 0 | 1 | 0 | 0 | 0 |
| Basophils-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Within-Within | 12 | 10 | 21 | 24 | 24 |
| Eosinophils-Above-Within | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Within-Above | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Above-Above | 0 | 1 | 2 | 0 | 0 |
| Hematocrit-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Hematocrit-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Hematocrit-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Hematocrit-Below-Within | 0 | 0 | 0 | 0 | 1 |
| Hematocrit-Within-Within | 12 | 12 | 22 | 22 | 23 |
| Hematocrit-Above-Within | 0 | 0 | 1 | 1 | 0 |
| Hematocrit-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Hematocrit-Within-Above | 0 | 0 | 0 | 1 | 0 |
| Hematocrit-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Within-Below | 0 | 0 | 2 | 0 | 0 |
| Hemoglobin-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Below-Within | 0 | 0 | 0 | 0 | 2 |
| Hemoglobin-Within-Within | 12 | 12 | 21 | 23 | 22 |
| Hemoglobin-Above-Within | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Within-Above | 0 | 0 | 0 | 1 | 0 |
| Hemoglobin-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Within-Within | 10 | 11 | 22 | 24 | 24 |
| Lymphocytes-Above-Within | 1 | 0 | 0 | 0 | 0 |
| Lymphocytes-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Within-Above | 1 | 0 | 1 | 0 | 0 |
| Lymphocytes-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Within-Below | 1 | 0 | 0 | 0 | 0 |
| Monocytes-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Below-Within | 0 | 0 | 0 | 1 | 0 |
| Monocytes-Within-Within | 11 | 11 | 23 | 23 | 23 |
| Monocytes-Above-Within | 0 | 0 | 0 | 0 | 1 |
| Monocytes-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Within-Above | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Neutrophils-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Neutrophils-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Neutrophils-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Neutrophils-Below-Within | 0 | 1 | 0 | 0 | 0 |
| Neutrophils-Within-Within | 12 | 10 | 20 | 22 | 24 |
| Neutrophils-Above-Within | 0 | 0 | 1 | 1 | 0 |
| Neutrophils-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Neutrophils-Within-Above | 0 | 0 | 2 | 1 | 0 |
| Neutrophils-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Platelets-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Platelets-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Platelets-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Platelets-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Platelets-Within-Within | 10 | 11 | 21 | 22 | 23 |
| Platelets-Above-Within | 1 | 0 | 0 | 1 | 1 |
| Platelets-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Platelets-Within-Above | 0 | 1 | 1 | 0 | 0 |
| Platelets-Above-Above | 1 | 0 | 1 | 1 | 0 |
| Erythrocytes-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Erythrocytes-Within-Below | 0 | 0 | 0 | 1 | 0 |
| Erythrocytes-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Erythrocytes-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Erythrocytes-Within-Within | 12 | 12 | 23 | 21 | 24 |
| Erythrocytes-Above-Within | 0 | 0 | 0 | 1 | 0 |
| Erythrocytes-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Erythrocytes-Within-Above | 0 | 0 | 0 | 1 | 0 |
| Erythrocytes-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Leukocytes-Below-Below | 0 | 1 | 0 | 0 | 0 |
| Leukocytes-Within-Below | 2 | 0 | 0 | 0 | 0 |
| Leukocytes-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Leukocytes-Below-Within | 0 | 1 | 0 | 1 | 2 |
| Leukocytes-Within-Within | 9 | 10 | 21 | 23 | 22 |
| Leukocytes-Above-Within | 0 | 0 | 1 | 0 | 0 |
| Leukocytes-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Leukocytes-Within-Above | 1 | 0 | 1 | 0 | 0 |
| Leukocytes-Above-Above | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| ALT-Below-Below | 0 | 0 | 0 | 0 | 0 |
| ALT-Within-Below | 0 | 0 | 0 | 0 | 0 |
| ALT-Above-Below | 0 | 0 | 0 | 0 | 0 |
| ALT-Below-Within | 0 | 0 | 0 | 0 | 0 |
| ALT-Within-Within | 7 | 10 | 20 | 20 | 20 |
| ALT-Above-Within | 1 | 0 | 0 | 1 | 1 |
| ALT-Below-Above | 0 | 0 | 0 | 0 | 0 |
| ALT-Within-Above | 0 | 0 | 1 | 0 | 0 |
| ALT-Above-Above | 0 | 0 | 0 | 1 | 0 |
| AST-Below-Below | 0 | 0 | 0 | 0 | 0 |
| AST-Within-Below | 0 | 0 | 0 | 0 | 0 |
| AST-Above-Below | 0 | 0 | 0 | 0 | 0 |
| AST-Below-Within | 0 | 0 | 0 | 0 | 0 |
| AST-Within-Within | 7 | 10 | 19 | 20 | 20 |
| AST-Above-Within | 1 | 0 | 0 | 0 | 0 |
| AST-Below-Above | 0 | 0 | 0 | 0 | 0 |
| AST-Within-Above | 0 | 0 | 2 | 2 | 1 |
| AST-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Creatinine-Below-Below | 0 | 2 | 0 | 0 | 0 |
| Creatinine-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Creatinine-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Creatinine-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Creatinine-Within-Within | 8 | 7 | 18 | 19 | 18 |
| Creatinine-Above-Within | 0 | 0 | 2 | 1 | 1 |
| Creatinine-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Creatinine-Within-Above | 0 | 0 | 1 | 1 | 1 |
| Creatinine-Above-Above | 0 | 1 | 0 | 1 | 1 |
| Blood urea-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Blood urea-Within-Below | 1 | 0 | 0 | 0 | 1 |
| Blood urea-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Blood urea-Below-Within | 1 | 0 | 1 | 0 | 1 |
| Blood urea-Within-Within | 6 | 10 | 20 | 22 | 19 |
| Blood urea-Above-Within | 0 | 0 | 0 | 0 | 0 |
| Blood urea-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Blood urea-Within-Above | 0 | 0 | 0 | 0 | 0 |
| Blood urea-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Basophils-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Basophils-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Basophils-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Basophils-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Basophils-Within-Within | 8 | 10 | 21 | 22 | 21 |
| Basophils-Above-Within | 0 | 0 | 0 | 0 | 0 |
| Basophils-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Basophils-Within-Above | 0 | 0 | 0 | 0 | 0 |
| Basophils-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Within-Within | 7 | 10 | 20 | 22 | 21 |
| Eosinophils-Above-Within | 0 | 0 | 1 | 0 | 0 |
| Eosinophils-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Eosinophils-Within-Above | 1 | 0 | 0 | 0 | 0 |
| Eosinophils-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Hematocrit-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Hematocrit-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Hematocrit-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Hematocrit-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Hematocrit-Within-Within | 8 | 10 | 18 | 22 | 20 |
| Hematocrit-Above-Within | 0 | 0 | 1 | 0 | 1 |
| Hematocrit-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Hematocrit-Within-Above | 0 | 0 | 2 | 0 | 0 |
| Hematocrit-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Below-Within | 0 | 0 | 0 | 1 | 1 |
| Hemoglobin-Within-Within | 8 | 10 | 21 | 21 | 20 |
| Hemoglobin-Above-Within | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Within-Above | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Within-Within | 8 | 10 | 20 | 22 | 21 |
| Lymphocytes-Above-Within | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes-Within-Above | 0 | 0 | 1 | 0 | 0 |
| Lymphocytes-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Within-Within | 8 | 10 | 21 | 22 | 21 |
| Monocytes-Above-Within | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Within-Above | 0 | 0 | 0 | 0 | 0 |
| Monocytes-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Neutrophils-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Neutrophils-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Neutrophils-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Neutrophils-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Neutrophils-Within-Within | 8 | 10 | 18 | 22 | 15 |
| Neutrophils-Above-Within | 0 | 0 | 2 | 0 | 6 |
| Neutrophils-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Neutrophils-Within-Above | 0 | 0 | 1 | 0 | 0 |
| Neutrophils-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Platelets-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Platelets-Within-Below | 0 | 0 | 0 | 1 | 0 |
| Platelets-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Platelets-Below-Within | 0 | 0 | 0 | 0 | 0 |
| Platelets-Within-Within | 8 | 10 | 19 | 21 | 20 |
| Platelets-Above-Within | 0 | 0 | 2 | 0 | 1 |
| Platelets-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Platelets-Within-Above | 0 | 0 | 0 | 0 | 0 |
| Platelets-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Erythrocytes-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Erythrocytes-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Erythrocytes-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Erythrocytes-Below-Within | 0 | 0 | 0 | 1 | 1 |
| Erythrocytes-Within-Within | 8 | 10 | 21 | 20 | 19 |
| Erythrocytes-Above-Within | 0 | 0 | 0 | 1 | 1 |
| Erythrocytes-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Erythrocytes-Within-Above | 0 | 0 | 0 | 0 | 0 |
| Erythrocytes-Above-Above | 0 | 0 | 0 | 0 | 0 |
| Leukocytes-Below-Below | 0 | 0 | 0 | 0 | 0 |
| Leukocytes-Within-Below | 0 | 0 | 0 | 0 | 0 |
| Leukocytes-Above-Below | 0 | 0 | 0 | 0 | 0 |
| Leukocytes-Below-Within | 0 | 0 | 1 | 0 | 1 |
| Leukocytes-Within-Within | 8 | 10 | 18 | 22 | 19 |
| Leukocytes-Above-Within | 0 | 0 | 2 | 0 | 1 |
| Leukocytes-Below-Above | 0 | 0 | 0 | 0 | 0 |
| Leukocytes-Within-Above | 0 | 0 | 0 | 0 | 0 |
| Leukocytes-Above-Above | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Number of Participants With Any SAE | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Number of Participants With AEs/SAEs Leading to Withdrawal From the Study | 0 | 0 | 0 | 0 | 0 |
Anti-Vi specific IgG antibodies were measured by an anti-Vi IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit. Blood samples were collected at specified timepoints.
| microgram per milliliter (µg/mL) | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Day 1 (pre-dose 1) | 1.10 (NA to NA) | 1.52 (0.93 to 2.48) | 1.14 (1.06 to 1.23) | 1.17 (1.03 to 1.33) | 1.10 (NA to NA) |
| Day 29 | 14.12 (8.21 to 24.29) | 19.61 (9.10 to 42.28) | 60.52 (35.28 to 103.82) | 36.97 (20.56 to 66.48) | 4.95 (3.23 to 7.59) |
| Day 169 (pre-Dose 2) | 4.36 (2.01 to 9.47) | 11.17 (4.79 to 26.03) | 18.58 (9.97 to 34.60) | 12.55 (7.06 to 22.32) | 6.18 (3.50 to 10.92) |
| Day 176 | 10.90 (4.72 to 25.21) | 18.78 (9.05 to 38.97) | 32.38 (19.82 to 52.89) | 56.78 (38.23 to 84.32) | 5.15 (3.02 to 8.77) |
| Day 197 | 10.16 (5.08 to 20.30) | 18.88 (8.23 to 43.29) | 33.75 (17.78 to 64.07) | 37.14 (23.79 to 58.00) | 5.17 (3.14 to 8.52) |
Anti-Vi specific IgG antibodies were measured by an anti-Vi IgG ELISA kit. Blood samples were collected at specified timepoints. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
| Ratio | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Day 29 | 12.84 (7.46 to 22.08) | 12.90 (6.77 to 24.58) | 53.01 (31.94 to 87.99) | 31.55 (18.74 to 53.11) | 4.50 (2.93 to 6.90) |
| Day 169 | 3.96 (1.82 to 8.61) | 7.11 (3.51 to 14.40) | 16.27 (8.94 to 29.61) | 10.65 (6.59 to 17.22) | 5.62 (3.18 to 9.93) |
| Day 176 | 9.91 (4.29 to 22.92) | 11.96 (6.05 to 23.65) | 28.19 (17.72 to 44.84) | 47.45 (36.38 to 61.89) | 4.68 (2.75 to 7.97) |
| Day 197 | 9.23 (4.62 to 18.46) | 11.00 (5.15 to 23.49) | 29.22 (15.71 to 54.35) | 31.04 (23.14 to 41.65) | 4.70 (2.85 to 7.74) |
Anti-Vi specific IgG antibodies were measured by an anti-Vi IgG ELISA kit. Blood samples were collected at specified timepoints. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
| Ratio | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Day 176 | 2.50 (1.63 to 3.83) | 1.68 (1.16 to 2.43) | 2.00 (1.06 to 3.80) | 4.20 (2.46 to 7.17) | 0.82 (0.47 to 1.43) |
| Day 197 | 2.33 (1.67 to 3.25) | 1.72 (1.17 to 2.54) | 1.71 (1.21 to 2.43) | 3.08 (2.09 to 4.53) | 0.77 (0.45 to 1.31) |
Anti-O:2 IgG antibodies in serum were measured by an ELISA assay. Blood samples were collected at specified timepoints.
| ELISA Units per milliliter (EU/mL) | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Day 1 (pre-dose 1) | 36.35 (15.21 to 86.89) | 28.31 (11.29 to 70.97) | 25.28 (14.73 to 43.39) | 25.90 (13.56 to 49.44) | 22.15 (13.18 to 37.23) |
| Day 29 | 4150.79 (1362.97 to 12640.82) | 559.62 (177.08 to 1768.50) | 4110.58 (1975.76 to 8552.10) | 668.30 (314.08 to 1422.01) | 28.19 (16.07 to 49.47) |
| Day 169 (pre-dose 2) | 702.49 (138.39 to 3565.88) | 298.02 (85.01 to 1044.76) | 894.08 (397.22 to 2012.40) | 268.09 (124.74 to 576.18) | 18.43 (10.91 to 31.13) |
| Day 176 | 1079.75 (322.08 to 3619.77) | 464.70 (188.39 to 1146.25) | 1342.38 (644.96 to 2793.95) | 522.60 (264.74 to 1031.60) | 18.24 (10.38 to 32.05) |
| Day 197 | 958.21 (298.69 to 3074.02) | 520.77 (167.69 to 1617.23) | 956.89 (440.21 to 2080.03) | 388.50 (219.98 to 686.13) | 17.28 (10.13 to 29.47) |
Anti-O:2 IgG antibodies in serum were measured by an ELISA assay. Blood samples were collected at specified timepoints. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
| Ratio | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Day 29 | 114.19 (44.83 to 290.86) | 19.77 (10.03 to 38.96) | 162.61 (91.17 to 290.04) | 25.81 (13.15 to 50.64) | 1.27 (1.02 to 1.60) |
| Day 169 | 26.15 (6.12 to 111.64) | 9.11 (3.83 to 21.64) | 37.28 (20.47 to 67.89) | 9.15 (4.52 to 18.51) | 0.92 (0.80 to 1.07) |
| Day 176 | 40.19 (11.79 to 136.94) | 14.20 (7.11 to 28.38) | 68.01 (39.46 to 117.23) | 19.12 (8.97 to 40.76) | 0.86 (0.77 to 0.96) |
| Day 197 | 35.66 (10.36 to 122.82) | 19.23 (9.58 to 38.60) | 51.16 (27.32 to 95.79) | 17.86 (9.42 to 33.86) | 0.95 (0.81 to 1.12) |
Anti-O:2 IgG antibodies in serum were measured by an ELISA assay. Blood samples were collected at specified timepoint. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
| Ratio | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Day 176 | 1.54 (0.82 to 2.88) | 1.56 (1.07 to 2.28) | 1.76 (1.31 to 2.36) | 1.89 (1.34 to 2.67) | 0.98 (0.92 to 1.04) |
| Day 197 | 1.36 (0.67 to 2.76) | 1.70 (0.90 to 3.22) | 1.60 (1.23 to 2.09) | 2.01 (1.42 to 2.84) | 0.99 (0.92 to 1.07) |
Blood samples were collected at specified timepoint for each component as measured by ELISA.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Day 1 | 0 | 2 | 0 | 1 | 0 |
| Day 29 | 12 | 10 | 22 | 23 | 13 |
| Day 169 | 6 | 10 | 20 | 18 | 13 |
| Day 176 | 6 | 9 | 19 | 21 | 12 |
| Day 197 | 7 | 9 | 20 | 22 | 12 |
Blood samples were collected at specified timepoint for each component as measured by ELISA.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Day 1 | 0 | 2 | 1 | 1 | 0 |
| Day 29 | 12 | 11 | 22 | 23 | 20 |
| Day 169 | 6 | 10 | 20 | 22 | 17 |
| Day 176 | 8 | 10 | 19 | 21 | 16 |
| Day 197 | 8 | 10 | 21 | 22 | 16 |
Blood samples were collected at specified timepoint for each component as measured by ELISA. 4-fold increase was defined as 4 times the baseline value of anti-O:2 IgG antibody concentrations.
| Participants | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Day 29 | 12 | 9 | 22 | 20 | 1 |
| Day 169 | 7 | 7 | 20 | 16 | 0 |
| Day 176 | 8 | 8 | 20 | 18 | 0 |
| Day 197 | 8 | 9 | 20 | 19 | 0 |
Collected over SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Step 1a: Low Dose TYP04A Vaccine Without Alum | 0/12 (0%) | 0/12 (0%) | 9/12 (75%) |
| Step 1b: Low Dose TYP03A Vaccine With Alum | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| Step 2: Full Dose TYP04B Vaccine Without Alum | 0/24 (0%) | 0/24 (0%) | 24/24 (100%) |
| Step 2: Full Dose TYP03B Vaccine With Alum | 0/24 (0%) | 0/24 (0%) | 24/24 (100%) |
| Control: TYPHIM VI and BOOSTRIX Vaccine | 0/24 (0%) | 0/24 (0%) | 24/24 (100%) |
| Event | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine |
|---|---|---|---|---|---|
| Administration site painGeneral disorders | 6/12 | 11/12 | 21/24 | 23/24 | 22/24 |
| HeadacheNervous system disorders | 6/12 | 6/12 | 14/24 | 11/24 | 17/24 |
| MyalgiaMusculoskeletal and connective tissue disorders | 4/12 | 4/12 | 12/24 | 16/24 | 13/24 |
| FatigueGeneral disorders | 4/12 | 5/12 | 11/24 | 15/24 | 15/24 |
| NasopharyngitisInfections and infestations | 0/12 | 4/12 | 3/24 | 5/24 | 5/24 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/12 | 3/12 | 4/24 | 3/24 | 4/24 |
| Administration site swellingGeneral disorders | 1/12 | 0/12 | 3/24 | 1/24 | 1/24 |
| ContusionInjury, poisoning and procedural complications | 0/12 | 1/12 | 3/24 | 0/24 | 0/24 |
| Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders | 0/12 | 0/12 | 3/24 | 2/24 | 0/24 |
| Abdominal painGastrointestinal disorders | 0/12 | 1/12 | 1/24 | 0/24 | 1/24 |
The analysis population comprised of exposed set which included all participants who were assigned to study intervention.
| Age, Continuous(Years) | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine | Total |
|---|---|---|---|---|---|---|
| Mean | 31.9 ± 10.8 | 31.8 ± 8.4 | 27.0 ± 9.2 | 27.1 ± 9.8 | 30.7 ± 10.6 | 29.2 ± 9.9 |
| Sex/Gender, Customized(Participants) | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine | Total |
|---|---|---|---|---|---|---|
| Male | 1 | 6 | 10 | 7 | 6 | 30 |
| Female | 11 | 6 | 14 | 17 | 18 | 66 |
| Race/Ethnicity, Customized(Participants) | Step 1a: Low Dose TYP04A Vaccine Without Alum | Step 1b: Low Dose TYP03A Vaccine With Alum | Step 2: Full Dose TYP04B Vaccine Without Alum | Step 2: Full Dose TYP03B Vaccine With Alum | Control: TYPHIM VI and BOOSTRIX Vaccine | Total |
|---|---|---|---|---|---|---|
| White | 12 | 12 | 24 | 24 | 24 | 96 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Ran from Nov 2022 to primary completion in Dec 2023, 12 months.
Results were first posted in Jan 2025, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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