A Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GSK Vaccines Institute for Global Health (GVGH) Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Young Adults

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorGlaxoSmithKline

About this trial

The current clinical study will evaluate the GVGH Quadrivalent Pan-Salmonella vaccine for the first time in healthy adults in Africa. The purpose of the current Phase 1 study is to evaluate the safety, reactogenicity, and the immune response induced by the Pan-Salmonella vaccine.

Eligibility criteria

Qualifiers

Participants 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 informed consent obtained from the participant prior to performance of any study specific procedure.

Healthy participants as established by medical history, clinical examination, and laboratory assessment*.

A male or female between and including 18 to 45 years of age at the time of the first study intervention administration, and no older than 45 years of age at second dose administration.

Disqualifiers

Known exposure to S. Typhi, S. Paratyphi A, and non-typhoidal Salmonella confirmed by blood culture during the period starting 3 years prior to first study intervention administration as confirmed using medical history.

History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Trial design

Treatments tested in this trial

  • Pan-Salmonella-with-Alum (Low dose) vaccine
  • Pan-Salmonella-with-Alum (Full dose) vaccine
  • Pan-Salmonella-without-Alum (Low dose) vaccine
  • Pan-Salmonella-without-Alum (Full dose) vaccine
  • Typhoid Vi conjugate vaccine
  • Placebo

Treatment groups

196 Participants
are divided into 5 treatment groups

Locations

This trial has no locations

Sponsors and collaborators