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
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2028-31-10
    Observational study model:
    Not applicable
    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:

      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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Will be 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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