| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05613205 | Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults | PHASE1 | COMPLETED | 97 | — | — | Nov 28, 2022 | Apr 2, 2024 | Jan 24, 2025 | 1 | Belgium |
Solicited administration site events included pain, redness, and swelling.
Solicited administration site events included pain, redness, and swelling.
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 solicited systemic events included arthralgia (joint pain), fatigue (tiredness), fever, headache, and myalgia (muscle pain).
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.
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.
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.
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 A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Inclusion Criteria: * Participants who, in the opinion of the Investigator, can and will comply with the requirements of the Protocol (e.g., completion of the diary cards, return for follow-up visits). * Written informed consent obtained from the participant prior to performance of any study specif...