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

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. - at Day 232, concomitantly during the last study intervention administration to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.

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. - at Day 232, concomitantly during the last study intervention administration to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.

Pentavalent vaccine is administered, as part of an Expanded Program on Immunization (EPI) vaccination, at the local EPI vaccination centers, and not part of the current clinical trial, at 6, 10 and 14 weeks of age to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.

Pneumococcal vaccine is administered, as part of an Expanded Program on Immunization (EPI) vaccination, at the local EPI vaccination centers, and not part of the current clinical trial, at 6, 10 and 14 weeks of age to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.

Inactivated polio vaccine is administered, as part of an Expanded Program on Immunization (EPI) vaccination, at the local EPI vaccination centers, and not part of the current clinical trial, at 6, 10 and 14 weeks of age to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.

-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 (during the Priming phase) and at Day 232 (during the Booster phase) to infants in the Infants\_6W\_Dose C and Infants\_6W\_Dose C\_2 groups.

-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 (during the Priming phase) and Day at 232 (during the Booster phase) to infants in the Infants\_6W\_Dose B and Infants\_6W\_Dose B\_2 groups.

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 (during the Priming phase) and Day at 232 (during the Booster phase) to infants in the Infants\_6W\_Dose A and Infants\_6W\_Dose A\_2 groups.

-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 (during the Priming phase) and at Day 232 (during the Booster phase) to infants in the Infants\_6W\_Control A, Infants\_6W\_Control B, Infants\_6W\_Control C and Infants\_6W\_Control\_2 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.

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.

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