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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
537
Low dose of iNTS-TCV vaccine will be administered.
Full dose of iNTS-TCV vaccine will be administered.
TYPHIBEV vaccine will be administered.
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.
Time frame: At Day 1, Day 85 and Day 337
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.
Time frame: At Day 1, Day 85 and Day 337
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.
Time frame: At Day 1, Day 85 and Day 337
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.
Time frame: From the first study intervention administration (Day 1) until study end (Day 505).
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention [for infants 6 MOA]
Time frame: From the first study intervention administration (Day 1) until study end (Day 505).
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Prevenar 13 vaccine will be administered.
Nimenrix vaccine will be administered.
Saline will be administered.
Number of participants with laboratory abnormalities [for infants 6 MOA]
Time frame: At 7 days after each study intervention administration (Day 8, Day 92 and Day 344).
Number of participants with solicited administration site events during 7 days after each study intervention administration [for infants 6 WOA]
Time frame: At Day 1, Day 57 and Day 232
Number of participants with solicited systemic events during 7 days after each study intervention administration [for infants 6 WOA]
Time frame: At Day 1, Day 57 and Day 232
Number of participants with unsolicited adverse events (AEs) during 28 days after each study intervention administration [for infants 6 WOA]
Time frame: At Day 1, Day 57 and Day 232
Number of participants with SAEs [for infants 6 WOA]
Time frame: From the first study intervention administration (Day 1) until study end (Day 400).
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention [for infants 6 WOA]
Time frame: From the first study intervention administration (Day 1) until study end (Day 400).
Number of participants with laboratory abnormalities [for infants 6 WOA]
Time frame: At 7 days after each study intervention administration (Day 8, Day 64 and Day 239).
Geometric Mean concentration (GMC) ratio of anti- S. typhimurium (STm) and anti- Salmonella Enteritidis (SEn) O-antigen (OAg) immunoglobulin G (IgG) [for infants 6 MOA]
Time frame: At 28 days after the second study intervention administration (Day 113)
GMC ratio of anti-Vi IgG [for infants 6 MOA]
Time frame: At 28 days after the first study intervention administration (Day 29)
GMC ratio of anti-STm and anti-SEn OAg IgG concentrations [for infants 6 WOA]
Time frame: At 28 days after the third study intervention administration (Day 260)
GMC ratio of anti-Vi IgG [for infants 6 WOA]
Time frame: At 28 days after the third study intervention administration (Day 260)
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG before each study intervention administration [for infants 6 MOA]
Time frame: At Day 1, Day 85 and Day 337
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG 28 days after each study intervention administration [for infants 6 MOA]
Time frame: At Day 29, Day 113 and Day 365
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG before each study intervention administration [for infants 6 WOA]
Time frame: At Day 1, Day 57 and Day 232
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG 28 days after each study intervention administration [for infants 6 WOA]
Time frame: At Day 29, Day 85 and Day 260
Number of participants achieving at least 2-fold and 4fold increase in antiserotype specific IgG concentrations [for infants 6 MOA]
Time frame: At 28 days after each study intervention administration (Day 29, Day 113 and Day 365) compared with before the first study intervention administration (Day 1)
Number of participants with anti-Vi IgG concentrations greater than or equal to (>=)2.0 micrograms per milliliter (µg/mL) and >=4.3 µg/mL [for infants 6 MOA]
Time frame: Before each study intervention administration (Day 1, Day 85 and Day 337) and 28 days after each study intervention administration (Day 29, Day 113 and Day 365)
Number of participants achieving at least 2-fold and 4fold increase in antiserotype specific IgG concentrations [for infants 6 WOA]
Time frame: At 28 days after each study intervention administration (Day 29, Day 85 and Day 260), compared with before the first study intervention administration (Day 1)
Number of participants with anti-Vi IgG concentrations >=2.0 µg/mL and >=4.3 µg/mL [for infants 6 WOA]
Time frame: Before each study intervention administration (Day 1, Day 57 and Day 232) and 28 days after each study intervention administration (Day 29, Day 85 and Day 260)