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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002029-19 | EudraCT Number |
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| Name | Class |
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| Biological E. Limited | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Step 1a: Low dose TYP04A vaccine without Alum | Experimental | Participants received low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169. |
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| Step 1b: Low dose TYP03A vaccine with Alum | Experimental | Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169. |
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| Step 2: Full dose TYP04B vaccine without Alum | Experimental | Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169. |
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| Step 2: Full dose TYP03B vaccine with Alum | Experimental | Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
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| Control: TYPHIM VI and BOOSTRIX vaccine | Active Comparator | Participants received TYPHIM VI as comparator intramuscularly on Day 1, and BOOSTRIX as comparator on Day 169. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TYP04A Low Dose without Alum investigational vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Administration-site Events After the First Vaccination | Solicited administration site events included pain, redness, and swelling. | 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. | 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). | 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). | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 specific procedure.
Healthy participants as established by medical history, clinical examination, and screening laboratory investigations.
Participant satisfying screening requirements.
Participant seronegative for human immunodeficiency virus, hepatitis B, and hepatitis C at Screening.
A male or female participant between, and including, 18 and 50 years of age at the time of the first study intervention administration.
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
Female participants of childbearing potential may be enrolled in the study if the participant:
Exclusion Criteria:
Medical conditions
Progressive, unstable or uncontrolled clinical conditions.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study.
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
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.
Confirmed positive COVID-19 test during the period starting 14 days before the first administration of study vaccines (Day -14 to Day 1).
Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study.
Confirmed or suspected autoimmune diseases (e.g., vitiligo, autoimmune thyroiditis).
Prior/Concomitant therapy
Previous administration of any type of Typhoid vaccine (Ty21a, Vi-PS, or Typhoid conjugate vaccine).
Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period starting 30 days before the first administration of study vaccines (Day -30 to Day 1), or planned use during the study period.
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.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention or planned administration during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose. For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants. Inhaled and topical steroids are allowed.
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.
Pregnant or lactating female.
Female participants planning to become pregnant or planning to discontinue contraceptive precautions.
History of or current chronic alcohol consumption and/or drug abuse.
Any study personnel or immediate dependents, family, or household member.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Edegem | 2610 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41587557 | Derived | De Coster I, AbdelGhany M, Sarakinou E, Fineschi C, Marchetti E, La Gaetana R, Nigro S, Carducci M, Massai L, Conti V, Rossi O, Luna Cilio G, Serry-Bangura A, Tessitore P, Van Damme P, Withanage K, Micoli F, Berlanda Scorza F, Rondini S, Nakakana UN, Kumar Arora A. Safety and immunogenicity of a conjugate vaccine candidate against Salmonella enterica serovars Typhi and Paratyphi A in healthy adults in Europe: a phase 1 randomised controlled trial. Lancet Infect Dis. 2026 Jun;26(6):638-650. doi: 10.1016/S1473-3099(25)00730-3. Epub 2026 Jan 23. |
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IPD for this study will be made available via the Clinical Study Data Request site.
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 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.
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Out of 97 participants enrolled, 1 participant, who underwent post-screening procedures, withdrew from the study before randomisation and did not receive the study intervention. Therefore, 96 participants were randomised in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Step 1a: Low Dose TYP04A Vaccine Without Alum | Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169. |
| FG001 | Step 1b: Low Dose TYP03A Vaccine With Alum |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 25, 2023 | Dec 4, 2024 |
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Data will be collected in an observer-blind (Day 1 to Day 29) and in a Single-blind (Day 29 to Day 337) manner with participants and investigator blinded.
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| TYP04B Full Dose without Alum investigational vaccine | Biological | 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. |
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| TYP03A Low Dose with Alum investigational vaccine | Biological | 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. |
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| TYP03B Full Dose with Alum investigational vaccine | Biological | 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. |
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| Sanofi Pasteur's Typhoid Vi polysaccharide vaccine | Biological | 1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly, at Day 1, to participants in the control group. |
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| GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine | Biological | 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. |
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| 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. | 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. | 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. | 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. | 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. | 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. | At Day 176 compared to Day 169 (Baseline) |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At Day 29, Day 169, Day 176 and Day 197 compared to Day 1 (baseline) |
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
| FG002 | Step 2: Full Dose TYP04B Vaccine Without Alum | Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169. |
| FG003 | Step 2: Full Dose TYP03B Vaccine With Alum | Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| FG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
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| NOT COMPLETED |
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The analysis population comprised of exposed set which included all participants who were assigned to study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Step 1a: Low Dose TYP04A Vaccine Without Alum | Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169. |
| BG001 | Step 1b: Low Dose TYP03A Vaccine With Alum | Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169. |
| BG002 | Step 2: Full Dose TYP04B Vaccine Without Alum | Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169. |
| BG003 | Step 2: Full Dose TYP03B Vaccine With Alum | Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| BG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Solicited Administration-site Events After the First Vaccination | Solicited administration site events included pain, redness, and swelling. | The analysis was performed on the solicited safety set, which included all participants who received at least 1 dose of the study intervention and had solicited safety data during the specified timepoints. | Posted | Count of Participants | Participants | From Day 1 to Day 7 |
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| Primary | Number of Participants With Solicited Administration-site Events After the Second Vaccination | Solicited administration site events included pain, redness, and swelling. | The analysis was performed on the Solicited safety set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Count of Participants | Participants | From Day 169 to Day 175 |
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| Primary | 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). | The analysis was performed on the Solicited safety set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Count of Participants | Participants | From Day 1 to Day 7 |
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| Primary | 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). | The analysis was performed on the Solicited safety set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Count of Participants | Participants | From Day 169 to Day 175 |
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| Primary | 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. | The analysis was performed on the unsolicited safety set, which included all participants who received at least 1 dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. | Posted | Count of Participants | Participants | From Day 1 to Day 28 |
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| Primary | 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. | The analysis was performed on the unsolicited safety set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Count of Participants | Participants | From Day 169 to Day 196 |
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| Primary | 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. | The analysis was performed on the exposed set, which included all participants who received at least 1 dose of the study intervention. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Count of Participants | Participants | From Day 1 to Day 197 |
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| Primary | 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. | The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Count of Participants | Participants | From Day 1 to Day 197 |
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| Primary | 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. | The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Count of Participants | Participants | From Day 1 to Day 197 |
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| Primary | 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. | The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Count of Participants | Participants | From Day 1 to Day 197 |
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| Primary | 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. | The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in the analysis. | Posted | Count of Participants | Participants | At Day 8 compared to Day 1 (Baseline) |
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| Primary | 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. | The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in the analysis. | Posted | Count of Participants | Participants | At Day 176 compared to Day 169 (Baseline) |
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| Secondary | 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. | The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in the analysis. | Posted | Count of Participants | Participants | From Day 197 to Day 337 |
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| Secondary | 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. | The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in the analysis. | Posted | Count of Participants | Participants | From Day 197 to Day 337 |
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| Secondary | 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. | The analysis was performed on Per-protocol set, which included all eligible participants who received each dose as per-protocol, had immunogenicity results post- dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination during the specified timepoints. | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter (µg/mL) | At Day 1 (pre-dose 1), Day 29, Day 169 (pre-Dose 2), Day 176 and Day 197 |
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| Secondary | 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. | The analysis was performed on the Per-protocol set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 29, Day 169, Day 176, and Day 197 compared to Day 1 (baseline) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the Per-protocol set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 176 and Day 197 compared to Day 169 (baseline) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the Per-protocol set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | ELISA Units per milliliter (EU/mL) | At Day 1 (pre-dose 1), Day 29, Day 169 (pre-dose 2), Day 176 and Day 197 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the Per-protocol set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 29, Day 169, Day 176, and Day 197 compared to Day 1 (baseline) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the Per-protocol set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 176 and Day 197 compared to Day 169 (baseline) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on Full Analysis Set (FAS), which included all participants who received at least 1 dose of the study intervention and had post- vaccination immunogenicity data during the specified timepoints. | Posted | Count of Participants | Participants | At Day 1, Day 29, Day 169, Day 176 and Day 197 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on FAS. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Count of Participants | Participants | At Day 1, Day 29, Day 169, Day 176 and Day 197 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on FAS. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | Count of Participants | Participants | At Day 29, Day 169, Day 176 and Day 197 compared to Day 1 (baseline) |
|
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).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Step 1a: Low Dose TYP04A Vaccine Without Alum | Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169. | 0 | 12 | 0 | 12 | 9 | 12 |
| EG001 | Step 1b: Low Dose TYP03A Vaccine With Alum | Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169. | 0 | 12 | 0 | 12 | 12 | 12 |
| EG002 | Step 2: Full Dose TYP04B Vaccine Without Alum | Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169. | 0 | 24 | 0 | 24 | 24 | 24 |
| EG003 | Step 2: Full Dose TYP03B Vaccine With Alum | Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. | 0 | 24 | 0 | 24 | 24 | 24 |
| EG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. | 0 | 24 | 0 | 24 | 24 | 24 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Thyroid calcification | Endocrine disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Administration site erythema | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Administration site pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Administration site pruritus | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Administration site swelling | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hangover | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site movement impairment | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vaccination site movement impairment | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Extraskeletal ossification | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Human papilloma virus test positive | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Alcoholic hangover | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Urethritis noninfective | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2022 | Dec 4, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014435 | Typhoid Fever |
| D010284 | Paratyphoid Fever |
| ID | Term |
|---|---|
| D012480 | Salmonella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089582 | Adjuvants, Vaccine |
| D014612 | Vaccines |
| C057664 | Vi polysaccharide vaccine, typhoid |
| C505143 | Boostrix |
| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D000276 | Adjuvants, Immunologic |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Female |
|
| Redness |
|
| Swelling |
|
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| OG003 |
| Step 2: Full Dose TYP03B Vaccine With Alum |
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| Step 2: Full Dose TYP03B Vaccine With Alum |
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| OG003 | Step 2: Full Dose TYP03B Vaccine With Alum | Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| Step 2: Full Dose TYP03B Vaccine With Alum |
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
| OG003 | Step 2: Full Dose TYP03B Vaccine With Alum | Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| OG003 | Step 2: Full Dose TYP03B Vaccine With Alum | Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| Step 2: Full Dose TYP04B Vaccine Without Alum |
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169. |
| OG003 | Step 2: Full Dose TYP03B Vaccine With Alum | Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| Step 2: Full Dose TYP04B Vaccine Without Alum |
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169. |
| OG003 | Step 2: Full Dose TYP03B Vaccine With Alum | Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| OG003 | Step 2: Full Dose TYP03B Vaccine With Alum | Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| Step 2: Full Dose TYP03B Vaccine With Alum |
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| OG003 | Step 2: Full Dose TYP03B Vaccine With Alum | Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| OG003 |
| Step 2: Full Dose TYP03B Vaccine With Alum |
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| Step 2: Full Dose TYP03B Vaccine With Alum |
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| Step 2: Full Dose TYP03B Vaccine With Alum |
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| Step 2: Full Dose TYP03B Vaccine With Alum |
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
| Step 2: Full Dose TYP03B Vaccine With Alum |
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
|
|
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| OG004 | Control: TYPHIM VI and BOOSTRIX Vaccine | Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169. |
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