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

NCT06213506 | Active Not Recruiting Phase 2

• 1 other identifier: 217218
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Salmonella Infections

Keywords

GVGH iNTS-GMMA vaccine; Safety; Reactogenicity; Immunogenicity; sub-Saharan Africa; African adults; children and infants; Age de-escalation; Invasive nontyphoidal Salmonella

Outcome Measures

Primary Outcomes (44)

• Number of adult participants 18-50 years of age with solicited administration site events

  The solicited administration site events are pain, redness and swelling.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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)

  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

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  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)

  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)

  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)

  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

  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

  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

  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

  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.

  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.

  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.

  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.

  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)

  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)

  During 28 days after the second study intervention administration occurring at Day 57

• Number of infant participants 6 weeks of age with SAEs

  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

  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

  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

  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

  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

  During 7 days after the third study intervention administration occurring at Day 232

• Number of infant participants 6 weeks of age with unsolicited AEs

  During 28 days after the third study intervention administration occurring at Day 232

• Number of infant participants 6 weeks of age with SAEs

  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

  From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)

Study Arms (18)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Biological: MenACWY; Biological: Measles and Rubella vaccine; Biological: Yellow Fever vaccine

Interventions

Measles and Rubella vaccine BIOLOGICAL

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.

Also known as: MR-VAC

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 vaccine BIOLOGICAL

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.

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

iNTS-GMMA Dose C BIOLOGICAL

-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.

Adults_Dose C Group; Children_Dose C Group; Infants_6W_Dose C Group; Infants_9M_Dose C Group

iNTS-GMMA Dose B BIOLOGICAL

-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.

Children_Dose B Group; Infants_6W_Dose B Group; Infants_9M_Dose B Group

iNTS-GMMA Dose A BIOLOGICAL

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.

Infants_6W_Dose A Group; Infants_9M_Dose A Group

MenACWY BIOLOGICAL

-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.

Also known as: Menveo

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+Hib COMBINATION_PRODUCT

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.

Also known as: Infanrix hexa

Infants_9M_Control A Group; Infants_9M_Control B Group; Infants_9M_Control C Group

Placebo DRUG

1 dose of Placebo administered intramuscularly at Day 57 to adults in the Adults\_Control group.

Adults_Control Group

Eligibility Criteria

• Age: 6 Weeks - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Kumasi, Ghana

Location

MeSH Terms

Conditions

Salmonella Infections

Interventions

MenACWY; Meningococcal Vaccines; diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; Rubella Vaccine; Yellow Fever Vaccine

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Viral Vaccines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data will be collected in an observer-blind manner.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 19, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

GH (1)