Salmonella InfectionsPhase 2NCT06213506

A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants

A Phase 2 study testing iNTS-GMMA Dose C, iNTS-GMMA Dose B and iNTS-GMMA Dose A in people with Salmonella Infections, run by GlaxoSmithKline at 1 site in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 weeks to 50 yearsHealthy volunteers can take part
Conditions the study is for: Salmonella Infections
What is being tested?: iNTS-GMMA Dose C, iNTS-GMMA Dose B and iNTS-GMMA Dose A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteGhana
Study dates: 15 Jan 2024to 6 Aug 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 weeks to 50 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

All participants (adults, children, infants at 9 months of age and infants at 6 weeks of age) will be enrolled in the clinical site in Ghana and must satisfy ALL the following criteria at study entry:
Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR), 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 or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure.
Healthy participants as established by medical history, clinical examination, and laboratory investigations.
Participants satisfying screening requirements.
Participants negative for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.

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Adult participants must satisfy ALL the following criteria in the study entry:
A male or female between and including 18 and 50 years of age at the time of the first study intervention administration.
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
Female participants of childbearing potential may be enrolled in the study, if the participant:
has practiced adequate contraception for 1 month prior to the study intervention administration, and
has a negative pregnancy test on the day of study intervention administration, and
has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
The Ghana card will be used as source document to verify the ages for the adults.
Child participants must satisfy ALL the following criteria at study entry:
A male or female between and including 24 and 59 months of age at the time of the first study intervention administration.
Previously completed routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR's.
Born after a gestation period of ≥37 weeks.
Infant participants must satisfy ALL the following criteria at study entry:
A male or female 6 weeks or 9 months of age at the time of the first study intervention administration.
Born after a gestation period of ≥37 weeks.
Born to a mother seronegative for HIV, hepatitis B virus and hepatitis C virus.
The Road to Health Chart will be used as source document to confirm the ages for the children and infants.

Who cannot join

Medical conditions
Known exposure to S. Typhimurium or S. Enteritidis during the period starting at birth for infants and children, and at 3 years for adults, as documented by patient records
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study.
Progressive, unstable, or uncontrolled clinical conditions.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

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Major congenital defects, as assessed by the investigator.
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Acute disease and/or fever at the time of enrollment (fever is defined as temperature ≥ 38.0°C).
Recurrent history or uncontrolled neurological disorders or seizures.
Any clinically significant hematological and/or biochemical laboratory abnormality.
Undernutrition defined as World Health Organization (WHO) Z-score less than -2 standard deviation (SD).
Malaria infection defined as the presence of asexual parasites in the blood.
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
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.
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
History of receiving any investigational iNTS or GMMA vaccines in the participant's life.
Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the first dose of study interventions, or their planned use during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 14 days before each dose and ending 28 days after the last dose of study interventions administration, with the exception of flu vaccines and vaccines administered as part of a public health vaccination campaign.
A vaccine not foreseen by the study protocol administered during the period starting at 14 days before the first dose and ending 14 days after the last dose of study interventions administration for live vaccines or 7 days in case of inactivated vaccines*, with the exception of flu vaccines or COVID-19 vaccine which may be considered on a case-by-case basis.
If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, provided it is used according to the local governmental recommendations and Sponsor is notified.
Under such circumstances, a participant may be considered eligible for study enrollment and/or study intervention administration after the appropriate window for delay has passed and inclusion/exclusion criteria have been re-checked, and if the participant is confirmed to be eligible.
Administration of long-acting immune-modifying drugs at any time during the study period.
Administration of immunoglobulins and/or any blood products or plasma derivatives from birth (for infants 6 weeks of age) or during the period starting 3 months before the administration of the first dose of study intervention(s) or planned administration during the study period.
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) up to the end of the study. For corticosteroids, this will mean prednisone equivalent >=20 mg/day for adult participants/ >=0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants (infants and children). Inhaled and topical steroids are allowed.
Prior/Concurrent clinical study experience
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, drug and device).
Other exclusions
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
History of/current chronic alcohol consumption and/or drug abuse. This will be decided at the discretion of the investigator.
Any study personnel or their immediate dependents, family, or household members.
Child in care.

Trial locations and contacts

1 site in 1 country.

Ghana1 site

GSK Investigational Site
Kumasi

Other trials in Ghana

About this study

Official title: A Phase IIa Observer-Blind, Randomized, Controlled, Age-De-Escalation, Single Center Interventional Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GVGH iNTS Vaccine Against S. Typhimurium and S. Enteritidis, in Adults, Children and Infants, in Africa

The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-generalized modules for membrane antigens (iNTS-GMMA) candidate vaccine against S. Typhimurium and S. Enteritidis with an age de-escalation and dose escalation approach in African population, starting with adults (18-50 years of age), then in children (24-59 months of age) and finally in infants (9 months and 6 weeks of age). Infants are the target for primary vaccination from 6 weeks of age.

Read the detailed description

The study will be conducted as follows:

Adult participants will receive either iNTS-GMMA Dose C (high) or a control vaccine intramuscularly on Day 1 and Day 57.
Child participants will receive either Dose B (medium) or Dose C (high) of the candidate vaccine or the control on Day 1 and Day 57.
Infant participants (9 months of age) will receive either Dose A (low), Dose B (medium), or Dose C (high) of the candidate vaccine or the control on Day 1, Day 85, and Day 169.
Infant participants (6 weeks of age) will receive either Dose A (low), Dose B (medium), or Dose C (high) of the candidate vaccine or the control on Day 1, Day 57 and Day 232.

Conditions: Salmonella Infections
Being tested: iNTS-GMMA Dose C, iNTS-GMMA Dose B, iNTS-GMMA Dose A, MenACWY, DTPa-HBV-IPV+Hib
Keywords: GVGH iNTS-GMMA vaccine, Safety, Reactogenicity, Immunogenicity, sub-Saharan Africa, African adults, children and infants, Age de-escalation, Invasive nontyphoidal Salmonella
Medical subject headings: Salmonella Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iNTS-GMMA Dose CBiological
-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults_Dose C and Children_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose C group, and at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Dose C group.
iNTS-GMMA Dose BBiological
-2 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1 and Day 57 to children in the Children_Dose B group; -3 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose B group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose B group.
iNTS-GMMA Dose ABiological
3 doses of iNTS-GMMA Dose A vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose A group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose A group.
MenACWYBiological
Also called Menveo
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups. A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
DTPa-HBV-IPV+HibCombination product
Also called Infanrix hexa
1 dose of DTPa-HBV-IPV+Hib vaccine administered intramuscularly at Day 169 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups.
PlaceboDrug
1 dose of Placebo administered intramuscularly at Day 57 to adults in the Adults_Control group.
Measles and Rubella vaccineBiological
Also called MR-VAC
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups. - at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Yellow Fever vaccineBiological
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups. - at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.

Study groups in NCT06213506
Study group	Role	What they receive
Adults_Dose C Group	Experimental	Adults, 18-50 years of age, will receive 2 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1 and Day 57. Receives: Biological: iNTS-GMMA Dose C
Adults_Control Group	Active comparator	Adults, 18-50 years of age, will receive 1 dose of the MenACWY vaccine at Day 1 and 1 dose of Placebo at Day 57. Receives: Biological: MenACWY; Drug: Placebo
Children_Dose B Group	Experimental	Children, 24-59 months of age, will receive 2 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1 and Day 57. Receives: Biological: iNTS-GMMA Dose B
Children_Control B Group	Active comparator	Children, 24-59 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 57. Receives: Biological: MenACWY
Children_Dose C Group	Experimental	Children, 24-59 months of age, will receive 2 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1 and Day 57. Receives: Biological: iNTS-GMMA Dose C
Children_Control C Group	Active comparator	Children, 24-59 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 57. Receives: Biological: MenACWY
Infants_9M_Dose A Group	Experimental	Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose A (low dose) vaccine at Day 1, Day 85 and Day 169. These infants will also receive an Expanded Program on Immunization (EPI) vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: iNTS-GMMA Dose A; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine
Infants_9M_Control A Group	Active comparator	Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: MenACWY; Combination Product: DTPa-HBV-IPV+Hib; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine
Infants_9M_Dose B Group	Experimental	Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1, Day 85 and Day 169. These infants will also receive an EPI vaccination withMR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: iNTS-GMMA Dose B; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine
Infants_9M_Control B Group	Active comparator	Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: MenACWY; Combination Product: DTPa-HBV-IPV+Hib; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine
Infants_9M_Dose C Group	Experimental	Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1, Day 85 and Day 169. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: iNTS-GMMA Dose C; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine
Infants_9M_Control C Group	Active comparator	Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: MenACWY; Combination Product: DTPa-HBV-IPV+Hib; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine
Infants_6W_Dose A Group	Experimental	Infants, 6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose A (low dose) vaccine at Day 1, Day 57 and at Day 232. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: iNTS-GMMA Dose A; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine
Infants_6W_Control A Group	Active comparator	Infants, 6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232 To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also will receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: MenACWY; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine
Infants_6W_Dose B Group	Experimental	Infants, 6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1, Day 57 and at Day 232. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: iNTS-GMMA Dose B; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine
Infants_6W_Control B Group	Active comparator	Infants ,6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232. To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: MenACWY; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine
Infants_6W_Dose C Group	Experimental	Infants ,6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1, Day 57 and at Day 232. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: iNTS-GMMA Dose C; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine
Infants_6W_Control C Group	Active comparator	Infants ,6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232. To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Receives: Biological: MenACWY; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of adult participants 18-50 years of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
Measured: During 7 days after the first study intervention administration occurring at Day 1
Number of adult participants 18-50 years of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
Measured: During 7 days after the second study intervention administration occurring at Day 57
Number of adult participants 18-50 years of age with solicited systemic events
The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue. Fever is defined as axillary temperature higher than or equal to (>=) 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F).
Measured: During 7 days after the first study intervention administration occurring at Day 1
Number of adult participants 18-50 years of age with solicited systemic events
The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Measured: During 7 days after the second study intervention administration occurring at Day 57
Number of adult participants 18-50 years of age with unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Measured: During 28 days after the first study intervention administration occurring at Day 1
Number of adult participants 18-50 years of age with unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Measured: During 28 days after the second study intervention administration occurring at Day 57
Number of adult participants 18-50 years of age with serious adverse events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in abnormal pregnancy outcomes.
Measured: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
Number of adult participants 18-50 years of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
Measured: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
Number of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Measured: At Day 8 (7 days after the first study intervention administration)
Number of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Measured: At Day 64 (7 days after the second study intervention administration)
Number of child participants 24-59 months of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
Measured: During 7 days after the first study intervention administration occurring at Day 1
Number of child participants 24-59 months of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
Measured: During 7 days after the second study intervention administration occurring at Day 57
Number of child participants 24-59 months of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Measured: During 7 days after the first study intervention administration occurring at Day 1
Number of child participants 24-59 months of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Measured: During 7 days after the second study intervention administration occurring at Day 57
Number of child participants 24-59 months of age with unsolicited AEs
Measured: During 28 days after the first study intervention administration occurring at Day 1
Number of child participants 24-59 months of age with unsolicited AEs
Measured: During 28 days after the second study intervention administration occurring at Day 57
Number of child participants 24-59 months of age with serious adverse events (SAEs)
Measured: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
Number of child participants 24-59 months of age with AEs leading to withdrawal from the study or discontinuation of study intervention
Measured: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
Number of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Measured: At Day 8 (7 days after the first study intervention administration)
Number of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Measured: At Day 64 (7 days after the second study intervention administration)
Number of infant participants 9 months of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
Measured: During 7 days after the first study intervention administration occurring at Day 1
Number of infant participants 9 months of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
Measured: During 7 days after the second study intervention administration occurring at Day 85
Number of infant participants 9 months of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
Measured: During 7 days after the third study intervention administration occurring at Day 169
Number of infant participants 9 months of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Measured: During 7 days after the first study intervention administration occurring at Day 1
Number of infant participants 9 months of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Measured: During 7 days after the second study intervention administration occurring at Day 85
Number of infant participants 9 months of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Measured: During 7 days after the third study intervention administration occurring at Day 169
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Measured: During 28 days after the first study intervention administration occurring at Day 1
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Measured: During 28 days after the second study intervention administration occurring at Day 85
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Measured: During 28 days after the third study intervention administration occurring at Day 169
Number of infant participants 9 months of age with serious adverse events (SAEs)
Measured: From first study intervention administration (Day 1) up to the end of study participation (Day 337)
Number of infant participants 9 months of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
Measured: From first study intervention administration (Day 1) up to the end of study participation (Day 337)
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Measured: At Day 8 (7 days after the first study intervention administration)
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Measured: At Day 92 (7 days after the second study intervention administration)
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Measured: At Day 176 (7 days after the third study intervention administration)
Number of infant participants 6 weeks of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
Measured: During 7 days after the first study intervention administration occurring at Day 1
Number of infant participants 6 weeks of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
Measured: During 7 days after the second study intervention administration occurring at Day 57
Number of infant participants 6 weeks of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Measured: During 7 days after the first study intervention administration occurring at Day 1
Number of infant participants 6 weeks of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Measured: During 7 days after the second study intervention administration occurring at Day 57
Number of infant participants 6 weeks of age with unsolicited adverse events (AEs)
Measured: During 28 days after the first study intervention administration occurring at Day 1
Number of infant participants 6 weeks of age with unsolicited adverse events (AEs)
Measured: During 28 days after the second study intervention administration occurring at Day 57
Number of infant participants 6 weeks of age with SAEs
Measured: From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
Number of infant participants 6 weeks of age with adverse events (AEs) leading to MR-VAC administration withdrawal from the study or discontinuation of study intervention
Measured: From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results
Measured: At Day 8 (7 days after the first study intervention administration)
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results at Day 64
Measured: At Day 64 (7 days after the second study intervention administration)

Secondary outcomes (14)

Number of infant participants 6 weeks of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
Measured: During 7 days after the third study intervention administration occurring at Day 232
Number of infant participants 6 weeks of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Measured: During 7 days after the third study intervention administration occurring at Day 232
Number of infant participants 6 weeks of age with unsolicited AEs
Measured: During 28 days after the third study intervention administration occurring at Day 232
Number of infant participants 6 weeks of age with SAEs
Measured: From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
Number of infant participants 6 weeks of age with adverse events (AEs) leading to withdrawal from the study or withholding further study intervention administration
Measured: From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results
Measured: At Day 239 (7 days after the study intervention administration)
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in adult participants 18-50 years of age
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
Measured: At Days 1 and 57 (before each study intervention administration) and at Days 29 and 85 (28 days after each study intervention administration)
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in child participants 24-59 months of age
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
Measured: At Days 1 and 57 (before each study intervention administration) and at Days 29 and 85 (28 days after each study intervention administration)
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infant participants 9 months of age
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
Measured: At Days 1, 85 and 169 (before each study intervention administration) and at Days 29, 113 and 197 (28 days after each study intervention administration)
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infant participants 6 weeks of age
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
Measured: At Days 1, 57 and 232 (before each study intervention administration) at Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration)
Number of adult participants 18-50 years of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG antibody concentrations are assessed.
Measured: At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
Number of child participants 24-59 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG antibody concentrations are assessed.
Measured: At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
Number of infant participants 9 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG antibody concentrations are assessed.
Measured: At Days 29, 113 and 197 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
Number of infant participants 6 weeks of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG antibody concentrations are assessed.
Measured: At Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 20246 Aug 2026

First posted19 Jan 2024
Study start15 Jan 2024
Primary completion6 Aug 2026
Study completion6 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Salmonella InfectionsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06213506
Sponsor's protocol ID: 217218
Status last verified: Sep 2026
First submitted: 19 Dec 2023
Last updated: 21 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa Observer-Blind, Randomized, Controlled, Age-De-Escalation, Single Center Interventional Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GVGH iNTS Vaccine Against S. Typhimurium and S. Enteritidis, in Adults, Children and Infants, in Africa
ClinicalTrials.gov ID: NCT06213506
Acronym / sponsor ID: 217218
Conditions: Salmonella Infections
Keywords: GVGH iNTS-GMMA vaccine, Safety, Reactogenicity, Immunogenicity, sub-Saharan Africa, African adults, children and infants, Age de-escalation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Jan 2024 (actual)
Primary completion: 6 Aug 2026 (actual)
Study completion: 6 Aug 2026 (actual)
First posted: 19 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will be conducted as follows:

Adult participants will receive either iNTS-GMMA Dose C (high) or a control vaccine intramuscularly on Day 1 and Day 57.
Child participants will receive either Dose B (medium) or Dose C (high) of the candidate vaccine or the control on Day 1 and Day 57.
Infant participants (9 months of age) will receive either Dose A (low), Dose B (medium), or Dose C (high) of the candidate vaccine or the control on Day 1, Day 85, and Day 169.
Infant participants (6 weeks of age) will receive either Dose A (low), Dose B (medium), or Dose C (high) of the candidate vaccine or the control on Day 1, Day 57 and Day 232.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 18

Arm	Type	Receives
Adults_Dose C Group	Experimental	Biological: iNTS-GMMA Dose CAdults, 18-50 years of age, will receive 2 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1 and Day 57.
Adults_Control Group	Active comparator	Biological: MenACWY, Drug: PlaceboAdults, 18-50 years of age, will receive 1 dose of the MenACWY vaccine at Day 1 and 1 dose of Placebo at Day 57.
Children_Dose B Group	Experimental	Biological: iNTS-GMMA Dose BChildren, 24-59 months of age, will receive 2 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1 and Day 57.
Children_Control B Group	Active comparator	Biological: MenACWYChildren, 24-59 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 57.
Children_Dose C Group	Experimental	Biological: iNTS-GMMA Dose CChildren, 24-59 months of age, will receive 2 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1 and Day 57.
Children_Control C Group	Active comparator	Biological: MenACWYChildren, 24-59 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 57.
Infants_9M_Dose A Group	Experimental	Biological: iNTS-GMMA Dose A, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose A (low dose) vaccine at Day 1, Day 85 and Day 169. These infants will also receive an Expanded Program on Immunization (EPI) vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_9M_Control A Group	Active comparator	Biological: MenACWY, Combination Product: DTPa-HBV-IPV+Hib, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_9M_Dose B Group	Experimental	Biological: iNTS-GMMA Dose B, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1, Day 85 and Day 169. These infants will also receive an EPI vaccination withMR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_9M_Control B Group	Active comparator	Biological: MenACWY, Combination Product: DTPa-HBV-IPV+Hib, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_9M_Dose C Group	Experimental	Biological: iNTS-GMMA Dose C, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1, Day 85 and Day 169. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_9M_Control C Group	Active comparator	Biological: MenACWY, Combination Product: DTPa-HBV-IPV+Hib, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Dose A Group	Experimental	Biological: iNTS-GMMA Dose A, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants, 6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose A (low dose) vaccine at Day 1, Day 57 and at Day 232. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Control A Group	Active comparator	Biological: MenACWY, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants, 6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232 To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also will receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Dose B Group	Experimental	Biological: iNTS-GMMA Dose B, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants, 6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1, Day 57 and at Day 232. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Control B Group	Active comparator	Biological: MenACWY, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants ,6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232. To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Dose C Group	Experimental	Biological: iNTS-GMMA Dose C, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants ,6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1, Day 57 and at Day 232. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Control C Group	Active comparator	Biological: MenACWY, Biological: Measles and Rubella vaccine, Biological: Yellow Fever vaccineInfants ,6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232. To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.

Who may qualify

Ages: 6 weeks to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (23 listed)

All participants (adults, children, infants at 9 months of age and infants at 6 weeks of age) will be enrolled in the clinical site in Ghana and must satisfy ALL the following criteria at study entry:
Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR), 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 or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure.
Healthy participants as established by medical history, clinical examination, and laboratory investigations.
Participants satisfying screening requirements.

Key exclusion criteria (34 listed)

Medical conditions
Known exposure to S. Typhimurium or S. Enteritidis during the period starting at birth for infants and children, and at 3 years for adults, as documented by patient records
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study.
Progressive, unstable, or uncontrolled clinical conditions.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iNTS-GMMA Dose C-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults_Dose C and Children_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose C group, and at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Dose C group.	Biological	Adults_Dose C Group, Children_Dose C Group, Infants_6W_Dose C Group, Infants_9M_Dose C Group
iNTS-GMMA Dose B-2 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1 and Day 57 to children in the Children_Dose B group; -3 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose B group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose B group.	Biological	Children_Dose B Group, Infants_6W_Dose B Group, Infants_9M_Dose B Group
iNTS-GMMA Dose A3 doses of iNTS-GMMA Dose A vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose A group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose A group.	Biological	Infants_6W_Dose A Group, Infants_9M_Dose A Group
MenACWYAlso: Menveo-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups. A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.	Biological	Adults_Control Group, Children_Control B Group, Children_Control C Group, Infants_6W_Control A Group, Infants_6W_Control B Group, Infants_6W_Control C Group, Infants_9M_Control A Group, Infants_9M_Control B Group, Infants_9M_Control C Group
DTPa-HBV-IPV+HibAlso: Infanrix hexa1 dose of DTPa-HBV-IPV+Hib vaccine administered intramuscularly at Day 169 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups.	Combination product	Infants_9M_Control A Group, Infants_9M_Control B Group, Infants_9M_Control C Group
Placebo1 dose of Placebo administered intramuscularly at Day 57 to adults in the Adults_Control group.	Drug	Adults_Control Group
Measles and Rubella vaccineAlso: MR-VACMeasles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups. - at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.	Biological	Infants_6W_Control A Group, Infants_6W_Control B Group, Infants_6W_Control C Group, Infants_6W_Dose A Group, Infants_6W_Dose B Group, Infants_6W_Dose C Group, Infants_9M_Control A Group, Infants_9M_Control B Group, Infants_9M_Control C Group, Infants_9M_Dose A Group, Infants_9M_Dose B Group, Infants_9M_Dose C Group
Yellow Fever vaccineYellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups. - at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.	Biological	Infants_6W_Control A Group, Infants_6W_Control B Group, Infants_6W_Control C Group, Infants_6W_Dose A Group, Infants_6W_Dose B Group, Infants_6W_Dose C Group, Infants_9M_Control A Group, Infants_9M_Control B Group, Infants_9M_Control C Group, Infants_9M_Dose A Group, Infants_9M_Dose B Group, Infants_9M_Dose C Group

Primary outcome

Number of adult participants 18-50 years of age with solicited administration site events
Time frame: During 7 days after the first study intervention administration occurring at Day 1
The solicited administration site events are pain, redness and swelling.
Number of adult participants 18-50 years of age with solicited administration site events
Time frame: During 7 days after the second study intervention administration occurring at Day 57
The solicited administration site events are pain, redness and swelling.
Number of adult participants 18-50 years of age with solicited systemic events
Time frame: During 7 days after the first study intervention administration occurring at Day 1
The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue. Fever is defined as axillary temperature higher than or equal to (>=) 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F).
Number of adult participants 18-50 years of age with solicited systemic events
Time frame: During 7 days after the second study intervention administration occurring at Day 57
The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Number of adult participants 18-50 years of age with unsolicited adverse events (AEs)
Time frame: During 28 days after the first study intervention administration occurring at Day 1
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Number of adult participants 18-50 years of age with unsolicited adverse events (AEs)
Time frame: During 28 days after the second study intervention administration occurring at Day 57
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Number of adult participants 18-50 years of age with serious adverse events (SAEs)
Time frame: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in abnormal pregnancy outcomes.
Number of adult participants 18-50 years of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
Time frame: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
Number of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Time frame: At Day 8 (7 days after the first study intervention administration)
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Number of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Time frame: At Day 64 (7 days after the second study intervention administration)
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Number of child participants 24-59 months of age with solicited administration site events
Time frame: During 7 days after the first study intervention administration occurring at Day 1
The solicited administration site events are pain, redness and swelling.
Number of child participants 24-59 months of age with solicited administration site events
Time frame: During 7 days after the second study intervention administration occurring at Day 57
The solicited administration site events are pain, redness and swelling.
Number of child participants 24-59 months of age with solicited systemic events
Time frame: During 7 days after the first study intervention administration occurring at Day 1
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Number of child participants 24-59 months of age with solicited systemic events
Time frame: During 7 days after the second study intervention administration occurring at Day 57
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Number of child participants 24-59 months of age with unsolicited AEs
Time frame: During 28 days after the first study intervention administration occurring at Day 1
Number of child participants 24-59 months of age with unsolicited AEs
Time frame: During 28 days after the second study intervention administration occurring at Day 57
Number of child participants 24-59 months of age with serious adverse events (SAEs)
Time frame: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
Number of child participants 24-59 months of age with AEs leading to withdrawal from the study or discontinuation of study intervention
Time frame: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
Number of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Time frame: At Day 8 (7 days after the first study intervention administration)
Number of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Time frame: At Day 64 (7 days after the second study intervention administration)
Number of infant participants 9 months of age with solicited administration site events
Time frame: During 7 days after the first study intervention administration occurring at Day 1
The solicited administration site events are pain, redness and swelling.
Number of infant participants 9 months of age with solicited administration site events
Time frame: During 7 days after the second study intervention administration occurring at Day 85
The solicited administration site events are pain, redness and swelling.
Number of infant participants 9 months of age with solicited administration site events
Time frame: During 7 days after the third study intervention administration occurring at Day 169
The solicited administration site events are pain, redness and swelling.
Number of infant participants 9 months of age with solicited systemic events
Time frame: During 7 days after the first study intervention administration occurring at Day 1
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Number of infant participants 9 months of age with solicited systemic events
Time frame: During 7 days after the second study intervention administration occurring at Day 85
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Number of infant participants 9 months of age with solicited systemic events
Time frame: During 7 days after the third study intervention administration occurring at Day 169
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Time frame: During 28 days after the first study intervention administration occurring at Day 1
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Time frame: During 28 days after the second study intervention administration occurring at Day 85
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Time frame: During 28 days after the third study intervention administration occurring at Day 169
Number of infant participants 9 months of age with serious adverse events (SAEs)
Time frame: From first study intervention administration (Day 1) up to the end of study participation (Day 337)
Number of infant participants 9 months of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
Time frame: From first study intervention administration (Day 1) up to the end of study participation (Day 337)
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Time frame: At Day 8 (7 days after the first study intervention administration)
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Time frame: At Day 92 (7 days after the second study intervention administration)
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Time frame: At Day 176 (7 days after the third study intervention administration)
Number of infant participants 6 weeks of age with solicited administration site events
Time frame: During 7 days after the first study intervention administration occurring at Day 1
The solicited administration site events are pain, redness and swelling.
Number of infant participants 6 weeks of age with solicited administration site events
Time frame: During 7 days after the second study intervention administration occurring at Day 57
The solicited administration site events are pain, redness and swelling.
Number of infant participants 6 weeks of age with solicited systemic events
Time frame: During 7 days after the first study intervention administration occurring at Day 1
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Number of infant participants 6 weeks of age with solicited systemic events
Time frame: During 7 days after the second study intervention administration occurring at Day 57
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature >= 38.0 °C/100.4 degrees °F.
Number of infant participants 6 weeks of age with unsolicited adverse events (AEs)
Time frame: During 28 days after the first study intervention administration occurring at Day 1
Number of infant participants 6 weeks of age with unsolicited adverse events (AEs)
Time frame: During 28 days after the second study intervention administration occurring at Day 57
Number of infant participants 6 weeks of age with SAEs
Time frame: From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
Number of infant participants 6 weeks of age with adverse events (AEs) leading to MR-VAC administration withdrawal from the study or discontinuation of study intervention
Time frame: From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results
Time frame: At Day 8 (7 days after the first study intervention administration)
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results at Day 64
Time frame: At Day 64 (7 days after the second study intervention administration)

14 secondary outcomes

Number of infant participants 6 weeks of age with solicited administration site events
Time frame: During 7 days after the third study intervention administration occurring at Day 232
Number of infant participants 6 weeks of age with solicited systemic events
Time frame: During 7 days after the third study intervention administration occurring at Day 232
Number of infant participants 6 weeks of age with unsolicited AEs
Time frame: During 28 days after the third study intervention administration occurring at Day 232
Number of infant participants 6 weeks of age with SAEs
Time frame: From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
Number of infant participants 6 weeks of age with adverse events (AEs) leading to withdrawal from the study or withholding further study intervention administration
Time frame: From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results
Time frame: At Day 239 (7 days after the study intervention administration)
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in adult participants 18-50 years of age
Time frame: At Days 1 and 57 (before each study intervention administration) and at Days 29 and 85 (28 days after each study intervention administration)
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in child participants 24-59 months of age
Time frame: At Days 1 and 57 (before each study intervention administration) and at Days 29 and 85 (28 days after each study intervention administration)
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infant participants 9 months of age
Time frame: At Days 1, 85 and 169 (before each study intervention administration) and at Days 29, 113 and 197 (28 days after each study intervention administration)
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infant participants 6 weeks of age
Time frame: At Days 1, 57 and 232 (before each study intervention administration) at Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration)
Number of adult participants 18-50 years of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Time frame: At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
Number of child participants 24-59 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Time frame: At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
Number of infant participants 9 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Time frame: At Days 29, 113 and 197 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
Number of infant participants 6 weeks of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Time frame: At Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing iNTS-GMMA Dose C, iNTS-GMMA Dose B and iNTS-GMMA Dose A in people with Salmonella Infections, run by GlaxoSmithKline at 1 site in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adult participants 18-50 years of age with solicited administration site events (time frame: During 7 days after the first study intervention administration occurring at Day 1). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06213506.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.