Last updated: 12/22/2025 07:20:23
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella vaccine in African childrenH06_04TP
GSK study ID
223136
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Trial overview
Official title: A Phase 2, Open-Label, Single-Center, Long-Term Immunogenicity Follow-Up Study of the GVGH altSonflex1-2-3 Shigella Vaccine 1, 2 and 3 Years after Vaccination in African Children
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA)
Timeframe: At Visit 1 of the current study (12 months after last vaccination in the parent studies)
Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA
Timeframe: At Visit 2 of the current study (24 months after last vaccination in the parent studies)
Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA
Timeframe: At Visit 3 of the current study (36 months after last vaccination in the parent studies)
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: AltSonflex1-2-3
Biological/vaccine: Menveo
Biological/vaccine: Infanrix hexa
Biological/vaccine: TYPHIBEV
Enrollment:
528
Observational study model:
Not applicable
Primary completion date:
2028-31-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diarrhoea
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2026 to October 2028
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
26 - 55 Months
Accepts healthy volunteers
Yes
- 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.
- Serious and significant progressive, unstable, or uncontrolled clinical condition(s).
- Any confirmed or suspected immunosuppressive or immunodeficient condition.
Inclusion and exclusion criteria
Inclusion criteria:
- Individuals in good health as determined by medical history since last study visit and clinical judgment of the investigator.
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.
Exclusion criteria:
- 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.
Serious and significant progressive, unstable, or uncontrolled clinical condition(s).
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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