Shigellosis Paediatrics
Conditions
Interventions
altSonflex1.2.3 vaccine low dose group
altSonflex1.2.3 vaccine middle dose group
altSonflex1.2.3 vaccine full dose group
Typhibev and Infanrix hexa group
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: • Participants’ parent(s)/LAR(s), 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 or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. • Healthy participants as established by medical history, clinical examination, and laboratory assessment. • Participants satisfying all screening requirements. • Participants seronegative for hepatitis B, and hepatitis C. • A male or female 9 months of age at the time of the first study intervention administration. • Normal nutritional (weight-for-length) Z score (-2 standard deviations or greater). • Previously completed routine childhood vaccinations to the best knowledge of the participant’s parent(s)/LAR(s). • Born at a gestation period of =37 weeks to the best knowledge of the participant’s parent(s)/LAR(s). • Participants negative for human immunodeficiency virus as confirmed by DNA polymerase chain reaction testing. • Participants negative for HLA-B27.
Exclusion criteria
Exclusion criteria: •History of any reaction or hypersensitivity associated with any component of the study interventions. •Any confirmed or suspected immunosuppressive or immunodeficient condition, •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality •Recurrent history or uncontrolled neurological disorders or seizures. •Any clinically significant hematological and/or biochemical laboratory abnormality. •Clinical conditions representing a contraindication to IM injections and/or blood draws. •Any behavioral or cognitive impairment or psychiatric disease that may interfere with the participant’s ability to participate in the study. •Confirmed positive COVID-19 from 28 days before the 1st dose •Acute or chronic illness which may be severe enough to preclude participation. •Any other clinical condition that, might pose additional risk to the participant due to participation in the study. •All medical conditions will be assessed by the Investigator who may use his/her discretion to decide if the participant meets the exclusion criteria. •Use of any investigational or non-registered product from (D-30 to 1) before the 1st dose of study interventions, or planned use during the study. •A vaccine not foreseen by the study protocol administered 14D pre 1st dose to 28D post last dose, with the exception of flu vaccines or COVID-19 vaccine. •Administration of long-acting immune-modifying drugs any time during the study period. •Administration of immunoglobulins and/or any blood products or plasma derivatives From 3Mo before 1st admin or throughout the study. •Chronic admin of immunosuppressants or other immune-modifying drugs from 3 Mo before 1st dose. •Prior receipt of an experimental Shigella vaccine or live Shigella challenge. •Known exposure to Shigella during lifetime of the participant as confirmed during interview with the participant’s parent(s)/LAR(s) or documented by participant’s records. •Child in care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-serotype-specific Shigella LPS/OAg* serum IgG GMCs/GMTs, as measured by ELISA, for each study intervention group.;Number of infants with at least a 4-fold increase in anti-serotypespecific Shigella LPS/OAg* serum IgG, as measured by ELISA, for each study intervention group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of infants with solicited administration-site events during the 7 days period after each study intervention administration;Number of infants with solicited systemic events during the 7 days period after each study intervention administration;Number of infants with SAEs during their entire study participation period;Number of infants with deviations from laboratory reference values or baseline values of hematological, renal, and hepatic panel test results, at 7 days after each study intervention administration ;Number of infants with unsolicited AEs during the 28 days period after each study intervention administration;Anti-measles IgG concentrations, as measured by ELISA;Anti-rubella IgG concentrations, as measured by ELISA;Number of infants achieving anti-measles IgG concentrations of =150 mIU/mL and =200 mIU/mL, as measured by ELISA;Number of infants achieving anti-rubella IgG concentrations of =4 IU/mL and =10 IU/mL, as measured by ELISA | — |
Countries
Kenya
Contacts
Public ContactLeelgo Mary Kimetto
Regulatory Officer
Outcome results
None listed