invasive nontyphoidal Salmonella (iNTS) disease and Typhoid Fever
Conditions
Interventions
Step 1a Group 1 iNTS TCV low dose at 6 MOA
Step 1a Control group 2 controls used in this group are TYPHIBEV Prevenar 13 and Nimenrix
Step 1b Group 3 iNTS TCV full dose at 6 MOA
Step 1b Group 4 iNTS TCV full dose including Prevenar 13 at 6 MOA
Step 1b Group 5 Control Group at 6 MOA including TYPHIBEV Prevenar 13 and Nimenrix
Step 1c Group 6 iNTS TCV low dose at 6 WOA
Step 1c Group 7 Control Group at 6 WOA including Nimenrix and TYPHIB
Step 1d Group 8 iNTS TCV full dose at 6 WOA
Step 1d Group 9 Control Group at 6 WOA including Nimenrix and TYPHIBE
Step 2 Group 10 iNTS TCV low dose at 6 WOA
Step 2 Group 11 iNTS TCV low dose and Saline at 6 WOA
Step 2 Group 12 iNTS TCV full dose at 6 WOA
Step 2 Group 13 iNTS TCV full dose and Saline Group at 6 WOA
Step 2 Group 14 Control Group at 6 WOA including Nimenrix and TYPHIBE
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have signed/thumb-printed, voluntary, informed consent provided for them by their parent/LAR prior to performance of any study-specific procedure. 2. Be a male or female infant aged 6 months (±2 weeks) (Steps 1a and 1b) or 6 weeks (+2 weeks) of age (Steps 1c, 1d, or 2) at the time of the first study vaccination. 3. Have a parent/LAR, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (eg, returning for follow-up visits). 4. Healthy as established by medical history, clinical examination, and laboratory assessment. 5. Have received all routine childhood vaccinations as per the age. 6. Have been born at full term (=37 weeks gestation) based on maternal report and additional antenatal records if available. 7. Have a parent/LAR who is willing to avoid the administration of local herbal/traditional medications (including topical treatments) throughout the study period and who is willing to consult, as applicable, the study team prior to the use on other medications including over the-counter medications not supplied by the study team (except in the case of an emergency) throughout the study period. 8. Have a readily identifiable place of residence within a reasonable travelling distance of the study site. 9. Have a parent/LAR with a means of telephone contact. 10. Have a parent/LAR who is willing to avoid vaccinations not provided by the study team throughout the participant’s enrollment in the study. All routine EPI vaccines due during the study (outside those given concurrently with the study vaccines/controls) will also be administered by the study team.
Exclusion criteria
Exclusion criteria: include but not limited to Participants must not: 1. Have had a known infection with STm, SEn or S. Typhi (eg, history of microbiologically confirmed iNTS infection). 2. history of allergic reactions to any prior vaccination or components of the investigational or control vaccines. 3. Hypersensitivity to latex. 4. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions. 5. history of anaphylaxis or other life-threatening allergic reactions. 6. Have any confirmed or suspected congenital or acquired immunosuppressive or immunodeficient condition, based on medical history and physical examination. 7. Any acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological abnormality or illness, as determined by medical history, physical examination, and (when applicable) baseline laboratory assessments. Known sickle cells disease (but not sickle cell trait) is an exclusion. 8. Have a bleeding or coagulation disorder contraindicating intramuscular injections or any other condition that in the judgment of the Investigator would make intramuscular injection unsafe. 9. Have a documented fever (axillary temperature =37.5ºC) at the time of enrollment/dosing or within the 48 hours preceding dosing (temporary exclusion if remains age-eligible/within the allowed interval of dosing). 10. Have clinically significant (moderate in severity) acute illness on the day of vaccination (temporary exclusion if remains age-eligible within the allowed dosing window). 11. Have any screening/last pre-dosing safety laboratory test (if applicable) with a toxicity score of =3 or a value judged to be clinically significant by the study clinician. 12. Have HIV, hepatitis B, or hepatitis C based on baseline serological assessment (these serological evaluations are only required during the screening phase). 13. Be known to vertically exposed to HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of solicited administration site and systemic events ;Occurrence of unsolicited AEs ;Occurrence of SAEs ;•Occurrence of AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention;•Occurrence of deviations from reference ranges or baseline values for hematological, renal, and hepatic panels test results ;•Anti-STm and anti-SEn OAg IgG concentrations as measured by ELISA;•Anti-Vi IgG concentrations as measured by ELISA;•Anti-STm and anti-SEn OAg IgG concentrations as measured by ELISA;•Anti-Vi IgG concentrations as measured by ELISA | — |
Secondary
| Measure | Time frame |
|---|---|
| • Anti-STm, anti-SEn OAg, and anti-Vi IgG concentrations as measured by ELISA;• Participants achieving at least 2 fold and 4-fold increase in anti serotype specific IgG as measured by ELISA.;• Participants with anti-Vi IgG concentrations =2.0 µg/mL and =4.3 µg/mL as measured by ELISA. | — |
Countries
Gambia
Contacts
Public ContactRita La Gaetana
Head of regulatory affairs at GSK GVGH
Outcome results
None listed