Diarrhoea
Conditions
Keywords
Shigella sonnei, Shigella flexneri, Shigella vaccine, altSonflex1-2-3, Shigelllosis
Brief summary
The current study is a follow-up to 2 previous parent studies, a dose-selection study with 3 different dose-levels of the altSonflex1-2-3 vaccine in a schedule of 3 vaccinations (H06\_01TP study \[NCT05073003, 212149\]) and a study with an alternate 2 vaccination schedule H06\_02TP study \[NCT06663436, 219449\]). The current study aims to assess the longevity of the immune response to the selected dose of the altSonflex1-2-3 vaccine 1, 2, and 3 years after the last vaccination in African children. The study involves no new vaccinations but will collect immunogenicity blood samples from participants.
Interventions
BIOLOGICALAltSonflex1-2-3
No intervention is administered in this extension study. The selected dose of altSonflex1-2-3 vaccine was administered intramuscularly in the participants' thigh during the H06\_01TP (212149) parent study on Day 1, Day 85, and Day 253; or on Day 1 and Day 169 during the H06\_02TP (219449) study.
BIOLOGICALMenveo
No intervention is administered in this extension study. The Menveo vaccine was administered intramuscularly in the participants' thigh on Day 1 and Day 85 during the H06\_01TP (212149) parent study.
BIOLOGICALInfanrix hexa
No intervention is administered in this extension study. The Infanrix hexa vaccine was administered intramuscularly in the participants' thigh on Day 281 during the H06\_01TP (212149) study; or on Day 169 during the H06\_02TP (219449) parent study.
BIOLOGICALTYPHIBEV
No intervention is administered in this extension study. The TYPHIBEV vaccine was administered intramuscularly in the participants' thigh on Day 1 during the H06\_02TP (219449) parent study.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open-label study.
Eligibility
Sex/Gender
ALL
Age
26 Months to 55 Months
Healthy volunteers
Yes
Inclusion criteria
* Children who, as infants, previously participated in two completed studies (H06\_01TP or H06\_02TP) 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
* 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 | Description |
|---|---|---|
| Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA) | At Visit 1 of the current study (12 months after last vaccination in the parent studies) | S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested. |
| Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA | At Visit 2 of the current study (24 months after last vaccination in the parent studies) | S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested. |
Contacts
Primary ContactUS GSK Clinical Trials Call Center
Backup ContactEU GSK Clinical Trials Call Center
Outcome results
None listed