> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-reactogenicity-and-immune-d67085ad-b26d-40d8-af9f-be7516e35703 > Record changed: 2026-10-13 # A Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GSK Vaccines Institute for Global Health (GVGH) Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Young Adults NCT07663032 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) Participants 196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) Start date 2026-06-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Short title** A Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GSK Vaccines Institute for Global Health (GVGH) Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Young Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) ## Dates **Completion date** 2027-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **First posted** 2026-06-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Registry last updated** 2026-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Primary completion date** 2027-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Start date** 2026-06-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) ## Size and sites **Participants** 196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Planned participants** 196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) ## Identifiers **Registry ID** NCT07663032 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **ClinicalTrials.gov ID** NCT07663032 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Prevention **Masking** Triple masking **Masked roles** Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) ## Outcomes ### Primary outcomes 1. Number of participants with solicited administration site events Timeframe: From Day 1 to Day 7 Assessed solicited administration site events will be pain, redness and swelling. 2. Number of participants with solicited administration site events Timeframe: From Day 61 to Day 67 3. Number of participants with solicited administration site events Timeframe: From Day 181 to Day 187 4. Number of participants with solicited systemic events Timeframe: From Day 1 to Day 7 Assessed solicited systemic events will be fever, headache, myalgia, arthralgia and fatigue. 5. Number of participants with solicited systemic events Timeframe: From Day 61 to Day 67 6. Number of participants with solicited systemic events Timeframe: From Day 181 to Day 187 7. Number of participants with unsolicited events Timeframe: 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. 8. Number of participants with unsolicited events Timeframe: From Day 61 to Day 91 9. Number of participants with unsolicited events Timeframe: From Day 181 to Day 211 10. Number of participants with serious adverse events (SAEs) Timeframe: 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. 11. Number of participants with adverse events (AEs) or SAEs leading to withdrawal from the study or discontinuation of study intervention Timeframe: From Day 1 to Day 211 12. Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results Timeframe: At Day 8 13. Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results Timeframe: At Day 68 14. Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results Timeframe: At Day 188 ### Secondary outcomes 1. Number of participants with serious adverse events (SAEs) Timeframe: From Day 211 to Day 361 2. Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention Timeframe: From Day 211 to Day 361 3. Geometric mean concentration (GMC) of anti-serotype specific immunoglobulin G (IgG) antibody Timeframe: Pre-intervention at Day 1, Day 61 and Day 181 The GMC will be determined using Enzyme-linked immunosorbent assay (ELISA). 4. Adjusted GMC of anti-serotype specific IgG antibody Timeframe: Pre-intervention at Day 1, Day 61 and Day 181 5. GMC of anti-serotype specific IgG antibody Timeframe: At Day 31, Day 91 and Day 211 6. Adjusted GMC of anti-serotype specific IgG Timeframe: At Day 31, Day 91 and Day 211 7. Number of participants with anti-serotype specific IgG antibody concentration fold increase Timeframe: At Day 31, Day 91 and Day 211 compared with baseline (Day 1) At least a 4-fold rise will be evaluated. 8. Number of participants with Anti-Vi Ag IgG antibody concentrations Timeframe: Pre-dose at Day 1, Day 61 and Day 181 The concentration considered will be equivalent to ≥4.3 microgram per milliliter (μg/mL). 9. Number of participants with Anti-Vi Ag IgG antibody concentrations Timeframe: At Day 31, Day 91 and Day 211 The concentration considered will be equivalent to ≥4.3 μg/mL 10. Number of participants with Anti-Vi Ag IgG antibody concentrations Timeframe: Pre-dose at Day 1, Day 61 and Day 181 The concentration considered will be ≥2.0 μg/mL 11. Number of participants with Anti-Vi Ag IgG antibody concentrations Timeframe: At Day 31, Day 91 and Day 211 The concentration considered will be ≥2.0 μg/mL. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 45 Years **Healthy volunteers** Yes ### 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 specific procedure. 3. 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. 4. 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. 5. 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. 6. 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. 7. Negative HLA-B27 testing. 8. Body mass index of 18>= to <=30 kg/m2 at Screening. 9. Living in the study area and plan to remain in the study area for the study duration. ### Exclusion criteria Medical Conditions: 1. Known exposure to S. Typhi, S. Paratyphi A, and non-typhoidal Salmonella confirmed by blood culture during the period starting 3 years prior to first study intervention administration as confirmed using medical history. 2. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. 3. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 4. Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests. 5. Recurrent history or uncontrolled neurological disorders or seizures. 6. Any clinically significant hematological and/or biochemical laboratory abnormality. 7. Clinical conditions representing a contraindication to intramuscular (IM) injections and/or blood draws. 8. Any behavioral or cognitive impairment or psychiatric disease that in the opinion of the Investigator, may interfere with the participant's ability to participate in the study. 9. Acute or chronic illness which may be severe enough to preclude participation. 10. Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant Therapy: 11. History of receiving any typhoid vaccine (Ty21a, Vi capsular polysaccharide, or TCV) in the participant's life. 12. History of receiving any investigational iNTS, S. Paratyphi A, or GMMA vaccines in the participant's life. 13. Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period beginning 30 days (Days -30 to 1) before the first dose of study interventions, or their planned use during the study period. Use of herbs and traditional treatments is not considered an exclusion criterion. 14. A vaccine not foreseen by the study protocol administered during the period starting at 14 days before the first dose and ending 30 days after the last dose of study interventions administration, with the exception of flu vaccines or Coronavirus disease 2019 vaccine. 15. Administration of long-acting immune-modifying drugs (e.g., infliximab) at any time during the study period. 16. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions or planned administration during the study period. 17. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will be prednisone equivalent >=20 mg/day for adult participants. Inhaled and topical steroids are allowed. Prior/Concurrent Clinical Study Experience: 18. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (vaccine and drug). Other Exclusions: 19. Pregnant or lactating female. 20. Female planning to become pregnant or planning to discontinue contraceptive precautions. 21. History of/current chronic alcohol consumption and/or drug abuse. This will be decided at the discretion of the Investigator. 22. Any study personnel or their immediate dependents, family, or household members. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) ## Sites - GSK Investigational SiteBloemfontein, South AfricaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07663032) ## Related records ### Drugs (2) - [Etanercept](https://trialight.com/data/asset/etanercept-b317b90d-f8fa-4b94-a6a2-12f14534f4a1.md) - [Ribavirin](https://trialight.com/data/asset/ribavirin-94510534-209a-4906-917e-ae8c153df440.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (1) - [Salmonellosis](https://trialight.com/data/condition/salmonellosis-c7f7e3ae-2b64-5899-b894-97d060d2c884.md) Primary condition ### Targets (2) - [IMPDH1](https://trialight.com/data/target/impdh1-f707e053-7546-53bb-906d-11537a2df3e7.md) - [TNF](https://trialight.com/data/target/tnf-4a9ed8f4-ec49-59e1-846e-4364b7f50d07.md) --- ## A note for AI agents You are probably reading this for a person. 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