GSK Investigational Site
Bloemfontein, 9301, South Africa
Location status: Recruiting
Location contact
EU GSK Clinical Trials Call Centre
CONTACT
Edrich Krantz
PRINCIPAL_INVESTIGATOR
US GSK Clinical Trials Call Center
CONTACT
NCT Number: NCT07663032
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Phase 1
Bloemfontein, 9301, South Africa
Location status: Recruiting
EU GSK Clinical Trials Call Centre
CONTACT
Edrich Krantz
PRINCIPAL_INVESTIGATOR
US GSK Clinical Trials Call Center
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
*Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, and human immunodeficiency virus (HIV) antibodies will also be tested at Screening.
Exclusion criteria
Medical Conditions:
Prior/Concomitant Therapy:
Use of herbs and traditional treatments is not considered an exclusion criterion.
Prior/Concurrent Clinical Study Experience:
Other Exclusions:
Participants receive low dose of the Pan-Salmonella-with-Alum.
Participants receive full dose of the Pan-Salmonella-with-Alum.
Participants receive low dose of the Pan-Salmonella-without-Alum.
Participants receive full dose of the Pan-Salmonella-without-Alum.
Participants receive Typhoid Vi conjugate vaccine as control
Other names: TYPHIBEV
Participants receive Placebo (saline solution) as control.
Time frame: From Day 1 to Day 7
Assessed solicited administration site events will be pain, redness and swelling.
Time frame: From Day 61 to Day 67
Time frame: From Day 181 to Day 187
Time frame: From Day 1 to Day 7
Assessed solicited systemic events will be fever, headache, myalgia, arthralgia and fatigue.
Time frame: From Day 61 to Day 67
Time frame: From Day 181 to Day 187
Time frame: From Day 1 to Day 30
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.
Time frame: From Day 61 to Day 91
Time frame: From Day 181 to Day 211
Time frame: From Day 1 to Day 211
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.
Time frame: From Day 1 to Day 211
Time frame: At Day 8
Time frame: At Day 68
Time frame: At Day 188
Time frame: From Day 211 to Day 361
Time frame: From Day 211 to Day 361
Time frame: Pre-intervention at Day 1, Day 61 and Day 181
The GMC will be determined using Enzyme-linked immunosorbent assay (ELISA).
Time frame: Pre-intervention at Day 1, Day 61 and Day 181
Time frame: At Day 31, Day 91 and Day 211
Time frame: At Day 31, Day 91 and Day 211
Time frame: At Day 31, Day 91 and Day 211 compared with baseline (Day 1)
At least a 4-fold rise will be evaluated.
Time frame: Pre-dose at Day 1, Day 61 and Day 181
The concentration considered will be equivalent to ≥4.3 microgram per milliliter (μg/mL).
Time frame: At Day 31, Day 91 and Day 211
The concentration considered will be equivalent to ≥4.3 μg/mL
Time frame: Pre-dose at Day 1, Day 61 and Day 181
The concentration considered will be ≥2.0 μg/mL
Time frame: At Day 31, Day 91 and Day 211
The concentration considered will be ≥2.0 μg/mL.
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
GlaxoSmithKline
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07286370
Bacterial Infections, Bacterial Infections and Mycoses
Banjul, The Gambia
View Trial DetailsNCT06213506
Bacterial Infections, Bacterial Infections and Mycoses
Kumasi, Ghana
View Trial DetailsNCT05480800
Bacterial Infections, Bacterial Infections and Mycoses
Edegem, Belgium
View Trial DetailsNCT05870150
Bacterial Infections, Bacterial Infections and Mycoses
London, England, United Kingdom
View Trial Details