Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children (H06_04TP)

December 22, 2025 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

528

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: H06_01TP Study_Infants_Selected dose
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.
Biological: AltSonflex1-2-3
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.
Other Names:
  • GSK's Shigella vaccine
Active Comparator: H06_01TP Study_ ST2_Infants_Control
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.
Biological: Menveo
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.
Other Names:
  • GSKs Meningococcal A, C, Y and W-135 conjugate vaccine
Biological: Infanrix 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.
Other Names:
  • GSKs Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine
Experimental: H06_02TP Study_Infants_Selected dose
Infants who received 2 doses of the altSonflex1-2-3 vaccine on Day 1 and Day 169 in the H06_02TP parent study.
Biological: AltSonflex1-2-3
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.
Other Names:
  • GSK's Shigella vaccine
Active Comparator: H06_02TP Study_ Infants_Control
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.
Biological: Infanrix 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.
Other Names:
  • GSKs Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine
Biological: TYPHIBEV
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.
Other Names:
  • Biological E. Limiteds Typhoid Vi-CRM197 conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA)
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
At Visit 3 of the current study (36 months after last vaccination in the parent studies)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 2, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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