A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-6
SponsorGlaxoSmithKline

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Low dose of iNTS-TCV
  • Full dose of iNTS-TCV
  • TYPHIBEV
  • Prevenar 13
  • Nimenrix
  • Saline

Treatment groups

537 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Sponsors and collaborators