Shigella
Conditions
Interventions
No intervention this is a longterm immunogenicity extension study recruiting predosed population
No intervention in this longterm immunogenicity extension study recruiting predosed population
Sponsors
GSK Vaccines Institute for Global Health S.r.l
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Children who, as infants, previously participated in two completed studies and were vaccinated with 3 or 2 doses of altSonflex1-2-3 or control vaccines, respectively, completed all previous vaccinations and are 12±1 months after the last altSonflex1-2-3 vaccination. • Individuals in good health as determined by medical history since last study visit and clinical judgment of the investigator.
Exclusion criteria
Exclusion criteria: Exclusion criteria • Serious and significant progressive, unstable, or uncontrolled clinical condition(s). • Any confirmed or suspected immunosuppressive or immunodeficient condition. • Clinical condition(s) representing a contraindication to blood draws. • Any behavioural or cognitive impairment or psychiatric disease. • Acute disease and/or fever at the time of enrollment. • 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. • Receipt of immunoglobulins and/or any blood products or plasma derivatives, during the period starting 3 months before each study visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-serotype specific Shigella lipopolysaccharide (LPS)/Oantigen (OAg)* serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay (ELISA) | — |
Secondary
| Measure | Time frame |
|---|---|
| EXPLORATORY Outcome (there are no secondary outcomes) - Functional immune response measured by anti-serotype specific serum bactericidal antibody at 12, 24, and 36 months after primary series completion for a 100% subset of participants - (there are no secondary outcomes). | — |
Countries
Kenya
Contacts
Public ContactRita La Gaetana
Senior Regulatory Lead GSK Vaccines Institute for Global Health S.r.l
Outcome results
None listed