> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/long-term-immunogenicity-of-the-altsonflex1-2-3-shigella-f29efef2-83d9-4585-aebc-37648bd0218b > Record changed: 2026-10-13 # Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children NCT07320716 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) Participants 528 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) Start date 2026-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Acronym** H06\_04TP Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Short title** Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) ## Dates **Completion date** 2028-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **First posted** 2026-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Registry last updated** 2026-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Primary completion date** 2028-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Start date** 2026-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) ## Size and sites **Participants** 528 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Planned participants** 528 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) ## Identifiers **Registry ID** NCT07320716 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **ClinicalTrials.gov ID** NCT07320716 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking **Masking description** This is an open-label study. Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) ## Outcomes ### Primary outcomes 1. 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) S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested. 2. 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) S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested. 3. 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) S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 26 Months **Maximum age** 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07320716) ## Related records ### Drugs (1) - [Neisseria meningitidis oligosaccharide conjugated to corynebacterium diphtheriae CRM197](https://trialight.com/data/asset/neisseria-meningitidis-oligosaccharide-conjugated-to-7ff6b6a9-731e-48bc-bd20-8d49660cb28c.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (1) - [Diarrheal disease](https://trialight.com/data/condition/diarrheal-disease-623389f5-2a35-5350-9dae-f2dc4bc0fc34.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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