Approval Probability
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Also known as Pan-Salmonella-with-Alum (Low dose) vaccine, Pan-Salmonella-with-Alum vaccine, Pan-Salmonella-without-Alum (Low dose) vaccine, Pan-Salmonella-without-Alum vaccine
Pan-Salmonella vaccine · 1 trial · 1 indication
Assessed solicited administration site events will be pain, redness and swelling.
Assessed solicited systemic events will be fever, headache, myalgia, arthralgia and fatigue.
An unsolicited adverse event (AE) is an AE that was either not included in the list of solicited AEs, or could. be included in the list of solicited AEs but with an onset outside the specified period of. follow-up for solicited AEs. Unsolicited AEs must have been communicated by participants who have signed informed consent. Unsolicited AEs include serious and non-serious AEs.
An SAE is defined as any untoward medical occurrence that, at any dose, results in persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, or results in death.
| Arm | Type | Description |
|---|---|---|
| Pan-Salmonella with Alum (Low dose) Group | EXPERIMENTAL | Participants will receive the low dose level of the candidate Pan-Salmonella-with-aluminium-hydroxide (Alum) vaccine at Days 1, 61 and 181. |
| Pan-Salmonella with Alum (Full dose) Group | EXPERIMENTAL | Participants will receive the full dose level of the candidate Pan-Salmonella-with-Alum vaccine at Days 1, 61 and 181. |
| Pan-Salmonella without Alum (Low dose) Group | EXPERIMENTAL | Participants will receive the low dose level of the candidate Pan-Salmonella-without-Alum vaccine at Days 1, 61 and 181. |
| Pan-Salmonella without Alum (Full dose) Group | EXPERIMENTAL | Participants will receive the full dose level of the candidate Pan-Salmonella-without-Alum vaccine at Days 1, 61 and 181. |
| Control Group | PLACEBO_COMPARATOR | Participants will receive placebo at Days 1 and 181, and Typhoid Vi conjugate vaccine at Day 61. |
| Name | Type | Description |
|---|---|---|
| Pan-Salmonella-with-Alum (Low dose) vaccine | BIOLOGICAL | Participants receive low dose of the Pan-Salmonella-with-Alum. |
| Pan-Salmonella-with-Alum (Full dose) vaccine | BIOLOGICAL | Participants receive full dose of the Pan-Salmonella-with-Alum. |
| Pan-Salmonella-without-Alum (Low dose) vaccine | BIOLOGICAL | Participants receive low dose of the Pan-Salmonella-without-Alum. |
| Pan-Salmonella-without-Alum (Full dose) vaccine | BIOLOGICAL | Participants receive full dose of the Pan-Salmonella-without-Alum. |
| Typhoid Vi conjugate vaccine | BIOLOGICAL | Participants receive Typhoid Vi conjugate vaccine as control |
| Placebo | OTHER | Participants receive Placebo (saline solution) as control. |
Inclusion Criteria: 1. 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). 2. Written informed consent obtained from the participant prior to performance of any study spec...