Typhoid FeverPhase 1NCT05613205
Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults
A Phase 1 study testing TYP04A Low Dose without Alum investigational vaccine, TYP04B Full Dose without Alum investigational vaccine and TYP03A Low Dose with Alum investigational vaccine in people with Typhoid Fever, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid Fever
- What is being tested?
- TYP04A Low Dose without Alum investigational vaccine, TYP04B Full Dose without Alum investigational vaccine and TYP03A Low Dose with Alum investigational vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Nov 2022to 2 Apr 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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:
- has practiced adequate contraception for 1 month prior to study intervention administration, and
- has a negative pregnancy test on the day of study intervention administration, and
- has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Observer-blind, Randomised, Controlled, Single-centre Study to Evaluate the Safety, Reactogenicity, and Immune Responses to an Adjuvanted and Non-adjuvanted Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults 18 to 50 Years of Age in Europe
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.
- Conditions
- Typhoid Fever
- Being tested
- TYP04A Low Dose without Alum investigational vaccine, TYP04B Full Dose without Alum investigational vaccine, TYP03A Low Dose with Alum investigational vaccine, TYP03B Full Dose with Alum investigational vaccine, Sanofi Pasteur's Typhoid Vi polysaccharide vaccine
- Keywords
- Salmonella Typhi, Salmonella Paratyphi A, Typhoid fever, Paratyphoid fever, Enteric fever, Conjugate vaccine, First-time-in-human
- Medical subject headings
- Typhoid Fever, Paratyphoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TYP04A Low Dose without Alum investigational vaccineBiological
Also called Typhoid and Paratyphoid A conjugate low dose without adjuvant 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.
TYP04B Full Dose without Alum investigational vaccineBiological
Also called Typhoid and Paratyphoid A conjugate full 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.
TYP03A Low Dose with Alum investigational vaccineBiological
Also called Adjuvanted Typhoid and Paratyphoid A conjugate low dose 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.
TYP03B Full Dose with Alum investigational vaccineBiological
Also called Adjuvanted Typhoid and Paratyphoid A conjugate full 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.
Sanofi Pasteur's Typhoid Vi polysaccharide vaccineBiological
Also called TYPHIM VI
1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly, at Day 1, to participants in the control group.
GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccineBiological
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: TYP04A Low Dose without Alum investigational vaccine |
| 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. Receives: Biological: TYP03A Low Dose with Alum investigational vaccine |
| 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. Receives: Biological: TYP04B Full Dose without Alum investigational vaccine |
| 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. Receives: Biological: TYP03B Full Dose with Alum investigational vaccine |
| 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. Receives: Biological: Sanofi Pasteur's Typhoid Vi polysaccharide vaccine; Biological: GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Administration-site Events After the First Vaccination
Solicited administration site events included pain, redness, and swelling.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 176 compared to Day 169 (Baseline)
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 29, Day 169, Day 176 and Day 197 compared to Day 1 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start28 Nov 2022
- Primary completion6 Dec 2023
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Typhoid FeverStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biological E. Limited
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613205
- Sponsor's protocol ID
- 205480
- Other IDs
- 2021-002029-19
- Status last verified
- Dec 2024
- First submitted
- 4 Nov 2022
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Carducci M, Sarakinou E, Massai L, Rovetini L, AbdelGhany M, Fineschi C, Nigro S, Marchetti E, La Gaetana R, Scorza FB, Arora AK, Conti V, Rossi O, Rondini S. Immunogenicity of a Bivalent Typhoid-Paratyphoid Conjugate Vaccine Against Diverse Salmonella Paratyphi A Isolates. J Infect Dis. 2026 Oct 15;234(4):e786-e796. doi: 10.1093/infdis/jiag275.
PubMed 42234814De 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.
PubMed 41587557
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Observer-blind, Randomised, Controlled, Single-centre Study to Evaluate the Safety, Reactogenicity, and Immune Responses to an Adjuvanted and Non-adjuvanted Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults 18 to 50 Years of Age in Europe
- ClinicalTrials.gov ID
- NCT05613205
- Acronym / sponsor ID
- 205480
- Conditions
- Typhoid Fever
- Keywords
- Salmonella Typhi, Salmonella Paratyphi A, Typhoid fever, Paratyphoid fever, Enteric fever, Conjugate vaccine, First-time-in-human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Biological E. Limited
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Step 1a: Low dose TYP04A vaccine without Alum | Experimental | Biological: TYP04A Low Dose without Alum investigational vaccineParticipants received low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169. |
| Step 1b: Low dose TYP03A vaccine with Alum | Experimental | Biological: TYP03A Low Dose with Alum investigational vaccineParticipants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169. |
| Step 2: Full dose TYP04B vaccine without Alum | Experimental | Biological: TYP04B Full Dose without Alum investigational vaccineParticipants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169. |
| Step 2: Full dose TYP03B vaccine with Alum | Experimental | Biological: TYP03B Full Dose with Alum investigational vaccineParticipants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169. |
| Control: TYPHIM VI and BOOSTRIX vaccine | Active comparator | Biological: Sanofi Pasteur's Typhoid Vi polysaccharide vaccine, Biological: GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccineParticipants received TYPHIM VI as comparator intramuscularly on Day 1, and BOOSTRIX as comparator on Day 169. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TYP04A Low Dose without Alum investigational vaccineAlso: Typhoid and Paratyphoid A conjugate low dose without adjuvant vaccine2 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. | Biological | Step 1a: Low dose TYP04A vaccine without Alum |
| TYP04B Full Dose without Alum investigational vaccineAlso: Typhoid and Paratyphoid A conjugate full dose without adjuvant vaccine2 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. | Biological | Step 2: Full dose TYP04B vaccine without Alum |
| TYP03A Low Dose with Alum investigational vaccineAlso: Adjuvanted Typhoid and Paratyphoid A conjugate low dose vaccine2 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. | Biological | Step 1b: Low dose TYP03A vaccine with Alum |
| TYP03B Full Dose with Alum investigational vaccineAlso: Adjuvanted Typhoid and Paratyphoid A conjugate full dose vaccine2 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. | Biological | Step 2: Full dose TYP03B vaccine with Alum |
| Sanofi Pasteur's Typhoid Vi polysaccharide vaccineAlso: TYPHIM VI1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly, at Day 1, to participants in the control group. | Biological | Control: TYPHIM VI and BOOSTRIX vaccine |
| GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccineAlso: BOOSTRIX1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine administered intramuscularly, at Day 169, to participants in the control group. | Biological | Control: TYPHIM VI and BOOSTRIX vaccine |
Primary outcome
Number of Participants With Solicited Administration-site Events After the First Vaccination
Time frame: From Day 1 to Day 7
Solicited administration site events included pain, redness, and swelling.
Number of Participants With Solicited Administration-site Events After the Second Vaccination
Time frame: From Day 169 to Day 175
Solicited administration site events included pain, redness, and swelling.
Number of Participants With Solicited Systemic Events After the First Vaccination
Time frame: From Day 1 to Day 7
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), fever, headache, and myalgia (muscle pain). Fever is defined as body temperature more than or equal to (>=) 38.0 degrees Celsius (°C).
Number of Participants With Solicited Systemic Events After the Second Vaccination
Time frame: From Day 169 to Day 175
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), fever, headache, and myalgia (muscle pain).
Number of Participants With Unsolicited Adverse Events (AEs) After the First Vaccination
Time frame: From Day 1 to Day 28
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Number of Participants With Unsolicited Adverse Events After the Second Vaccination
Time frame: From Day 169 to Day 196
An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Number of Participants With Any Serious Adverse Events (SAEs)
Time frame: From Day 1 to Day 197
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
Number of Participants With AEs/SAEs Leading to Withdrawal From the Study
Time frame: From Day 1 to Day 197
Any AEs including SAEs that lead to withdrawal from the study are considered under this outcome measure. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.
Number of Participants With SAEs Leading to Withholding Further Study Intervention Administration
Time frame: From Day 1 to Day 197
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. SAEs that lead to withholding of the study intervention administration were considered under this outcome measure.
Number of Participants With AEs Leading to Withholding Further Study Intervention Administration
Time frame: From Day 1 to Day 197
An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. AEs that lead to withholding of the study intervention administration were considered under this outcome measure.
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Time frame: At Day 8 compared to Day 1 (Baseline)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, hematocrit, lymphocytes, monocytes, neutrophils, platelets, leukocytes. Hepatic laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST] and renal laboratory parameters include creatinine and blood urea. Categories reported when comparing Day 1 (baseline) and Day 8 hematological, renal and hepatic laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Range level being classified as below, within or above the normal range.
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Time frame: At Day 176 compared to Day 169 (Baseline)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, hematocrit, lymphocytes, monocytes, neutrophils, platelets, leukocytes. Hepatic laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST] and renal laboratory parameters include creatinine and blood urea. Categories reported when comparing Day 169 (baseline) and Day 176 hematological, renal and hepatic laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Range level being classified as below, within or above the normal range.
11 secondary outcomes
Number of Participants With Any SAE
Time frame: From Day 197 to Day 337
Number of Participants With AEs/SAEs Leading to Withdrawal From the Study
Time frame: From Day 197 to Day 337
Geometric Mean Concentrations (GMCs) of Anti-Vi Antigen Immunoglobulin G (IgG) Antibody Concentrations
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
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
Time frame: At Day 176 and Day 197 compared to Day 169 (baseline)
GMC of Anti-O:2 IgG Antibody Concentrations
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
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
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)
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
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
Time frame: At Day 29, Day 169, Day 176 and Day 197 compared to Day 1 (baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42234814Carducci M, Sarakinou E, Massai L, Rovetini L, AbdelGhany M, Fineschi C, Nigro S, Marchetti E, La Gaetana R, Scorza FB, Arora AK, Conti V, Rossi O, Rondini S. Immunogenicity of a Bivalent Typhoid-Paratyphoid Conjugate Vaccine Against Diverse Salmonella Paratyphi A Isolates. J Infect Dis. 2026 Oct 15;234(4):e786-e796. doi: 10.1093/infdis/jiag275.
- Derived from this study: PubMed 41587557De 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.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TYP04A Low Dose without Alum investigational vaccine, TYP04B Full Dose without Alum investigational vaccine and TYP03A Low Dose with Alum investigational vaccine in people with Typhoid Fever, run by GlaxoSmithKline at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited Administration-site Events After the First Vaccination (time frame: From Day 1 to Day 7). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05613205, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.