The purpose of this study is to evaluate the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) vaccine in infants with the first dose administered at 6 months of age (MOA) or 6 weeks of age (WOA).
Have signed/thumb-printed, voluntary, informed consent provided for them by their parent/Legally Authorized Representative (LAR) prior to performance of any study-specific procedure.
Be a male or female infant aged 6 months (±2 weeks) or 6 weeks (+2 weeks) of age at the time of the first study vaccination.
Have a parent/LAR, who can and will comply with the requirements of the protocol.
Healthy as established by medical history, clinical examination, and laboratory assessment.
Have had a known infection with STm, SEn or S. Typhi.
Have a history of allergic reactions to any prior vaccination or components of the investigational or control vaccines.
Hypersensitivity to latex.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
Parallel
Low dose of iNTS-TCV
Biological/VaccineLow dose of iNTS-TCV vaccine will be administered.
Full dose of iNTS-TCV
Biological/VaccineFull dose of iNTS-TCV vaccine will be administered.
TYPHIBEV
Biological/VaccineTYPHIBEV vaccine will be administered.
Prevenar 13
Combination productPrevenar 13 vaccine will be administered.
Nimenrix
Combination productNimenrix vaccine will be administered.
Saline
DrugSaline will be administered.
14
Treatment groupsSee each treatment group below.
Number of participants with solicited administration site events during 7 days after each study intervention administration [for infants 6 MOA]
Solicited administration site events included pain, redness, and swelling.
Number of participants with solicited systemic events during 7 days after each study intervention administration [for infants 6 MOA]
Solicited systemic events included Fever, Irritability/Fussiness, Loss of appetite, Somnolence (sleepiness/drowsiness) and Vomiting. Fever is defined as body temperature more than or equal to (\>=) 37.5 degrees Celsius (°C), measured from axilla.
Number of participants with unsolicited adverse events (AEs) during 28 days after each study intervention administration [for infants 6 MOA]
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Number of participants with serious adverse events (SAEs) [for infants 6 MOA]
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG before each study intervention administration [for infants 6 MOA]
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG 28 days after each study intervention administration [for infants 6 MOA]
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG before each study intervention administration [for infants 6 WOA]
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG 28 days after each study intervention administration [for infants 6 WOA]
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