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A Phase 1, Randomized, Controlled, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the GVGH Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Adults 18 to 45 Years of Age in Africa

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The current clinical study will evaluate the GVGH Quadrivalent Pan-Salmonella vaccine for the first time in healthy adults in Africa. The purpose of the current Phase 1 study is to evaluate the safety, reactogenicity, and the immune response induced by the Pan-Salmonella vaccine.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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 laboratory assessment\*.

• \*Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, and human immunodeficiency virus (HIV) antibodies will also be tested at Screening.

• A male or female between and including 18 to 45 years of age at the time of the first study intervention administration, and no older than 45 years of age at second dose administration.

• Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, or menopause.

• Participants of childbearing potential may be enrolled in the study if the participant:

‣ Has practiced adequate contraception (as indicated in Section 10.5) for at least 30 days prior to study intervention administration, and

⁃ Has a negative pregnancy test within 24 hours prior to the study intervention administration, and

⁃ Has agreed to continue adequate contraception during the entire treatment period and for 8 weeks after completion of the study intervention administration series.

• Negative HLA-B27 testing.

• Body mass index of 18\>= to \<=30 kg/m2 at Screening.

• Living in the study area and plan to remain in the study area for the study duration.

Locations
Other Locations
South Africa
GSK Investigational Site
RECRUITING
Bloemfontein
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2026-06-24
Estimated Completion Date: 2027-11-14
Participants
Target number of participants: 196
Treatments
Experimental: Pan-Salmonella with Alum (Low dose) Group
Participants will receive the low dose level of the candidate Pan-Salmonella-with-aluminium-hydroxide (Alum) vaccine at Days 1, 61 and 181.
Experimental: Pan-Salmonella with Alum (Full dose) Group
Participants will receive the full dose level of the candidate Pan-Salmonella-with-Alum vaccine at Days 1, 61 and 181.
Experimental: Pan-Salmonella without Alum (Low dose) Group
Participants will receive the low dose level of the candidate Pan-Salmonella-without-Alum vaccine at Days 1, 61 and 181.
Experimental: Pan-Salmonella without Alum (Full dose) Group
Participants will receive the full dose level of the candidate Pan-Salmonella-without-Alum vaccine at Days 1, 61 and 181.
Placebo_comparator: Control Group
Participants will receive placebo at Days 1 and 181, and Typhoid Vi conjugate vaccine at Day 61.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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