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H06_04TPNCT07320716

Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Enrollment reduced 66%.

See at-risk trials from GlaxoSmithKline

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 528 → 179 participants Show 6 more changesShow less
    • Recruitment opened
    • Primary endpoints: details revised at 3 of 3 entries
    • Study sites: 0 to 1
    • Primary and study completion dates: Oct 31, 2028 to Oct 16, 2028
    • Start date changed from estimate of Jan 2, 2026 to Feb 6, 2026
    • Eligibility criteria expanded, about 9 words
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

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)

Arms and interventions

H06_01TP Study_Infants_Selected doseExperimental

Infants who received 3 doses of the altSonflex1-2-3 vaccine on Day 1, Day 85, and Day 253 in the H06\_01TP parent study.

H06_01TP Study_ ST2_Infants_ControlActive comparator

Infants who received 2 doses of the Menveo vaccine on Day 1 and Day 85, and 1 dose of the Infanrix hexa vaccine on Day 281 in the H06\_01TP parent study.

H06_02TP Study_Infants_Selected doseExperimental

Infants who received 2 doses of the altSonflex1-2-3 vaccine on Day 1 and Day 169 in the H06\_02TP parent study.

H06_02TP Study_ Infants_ControlActive comparator

Infants who received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix hexa vaccine on Day 169 in the H06\_02TP parent study.

Biologicals: AltSonflex1-2-3, Menveo, Infanrix hexa, TYPHIBEV

Sites

1 site in 1 country

  • GSK Investigational SiteKericho, Kenya