Prophylaxis for Shigellosis induced by Shigella sonnei, Shigella flexneri 1b, Shigella flexneri 2a and Shigella flexneri 3a
Conditions
Interventions
Product Name: altSonflex1-2-3
Product Code: GSK4001785A
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Not applicable
Current Sponsor code: 2929-GMMA
Other descriptive name: Shigel
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female children who, as infants, previously participated in the H06_01TP or H06_02TP study and were vaccinated with 3 or 2 doses of altSonflex1-2-3 or control vaccines, respectively, who completed all vaccinations as per the H06_01TP or H06_02TP parent study designs and are 12±1 months after last vaccination of either parent study. 2) Participants and/or participants’ parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., return for follow-up visits). 3) 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. 4) Individuals in good health as determined by medical history since last study visit in the H06_01TP or H06_02TP study and clinical judgment of the investigator. Are the trial subjects under 18? yes Number of subjects for this age range: 179 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Serious and significant progressive, unstable, or uncontrolled clinical condition(s). 2) Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 3) Clinical condition(s) representing a contraindication to blood draws (individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time). 4) Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant’s ability to participate in the study. 5) Acute disease and/or fever (defined as temperature =38.0°C) at the time of enrollment. The participant can still be enrolled into the study at a time when the acute disease and/or fever has resolved. 6) Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. 7) Individuals with history of any illness that, in the opinion of the investigator, may pose additional risk to the participants due to participation in the study 8) Individuals with known or suspected HIV infection or HIV-related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days, or were in chemotherapy treatment within the past 6 months. 9) Administration of long-acting immune-modifying drugs (e.g., infliximab) at any time before or during the study period. 10) Use of any investigational or non-registered product (drug, vaccine, or medical device)* during the period starting 30 days before the first study procedure (Day -30 to Day 1), or planned use during the study period. *Use of herbs and traditional treatments is not considered an exclusion criterion. 11) Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before each study visit 12) Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to each study visit. For corticosteroids, this will mean prednisone =0.5 mg/kg/day or 20 mg/day, whichever is the maximum dose for pediatric participants. Inhaled and topical steroids are allowed. 13) Individuals who have received any vaccine against Shigella outside H06_01TP or H06_02TP study procedures. 14) Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug or invasive medical device) 15) Any study personnel or immediate dependents, family, or household member. 16) Child in care. Please refer to the Section List of Abbreviations And Definitions of Terms for the definition of child in care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term immune response induced by two or three primary doses of altSonflex1-2-3 vaccine;Secondary Objective: Not applicable;Primary end point(s): Anti-serotype specific Shigella lipopolysaccharide (LPS)/Oantigen (OAg)* serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay (ELISA). *S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested. ;Timepoint(s) of evaluation of this end point: At 12, 24, and 36 months after last vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Kenya
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed