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Also known as 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...
The Pan-Salmonella vaccine is an investigational vaccine being developed by GSK plc for the prevention of Salmonella Infections. It is a quadrivalent vaccine candidate from the GSK Vaccines Institute for Global Health (GVGH). It is currently in Phase 1 clinical development and has not been approved for use.
The Pan-Salmonella vaccine is being developed by GSK plc, which trades under the ticker GSK. The candidate comes from the GSK Vaccines Institute for Global Health (GVGH), the company's vaccine research unit focused on global health pathogens.
The Pan-Salmonella vaccine is in Phase 1 clinical development. It is an investigational vaccine and is not approved for any indication. One Phase 1 trial is currently active and recruiting participants, and no trials of this candidate have been completed.
The Pan-Salmonella vaccine is being studied in trial NCT07663032, titled a study to evaluate the safety, reactogenicity, and immune response of the GVGH quadrivalent Pan-Salmonella vaccine with and without alum in healthy young adults. The Phase 1 trial is recruiting 196 healthy volunteers aged 18 years and older in South Africa.
The Phase 1 trial NCT07663032 is a randomized, double-blind, placebo-controlled study enrolling 196 healthy volunteers aged 18 years and older in South Africa. It evaluates the safety, reactogenicity, and immune response of the quadrivalent Pan-Salmonella vaccine administered with and without alum.