Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07320716

Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diarrhoea Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

26 month–55 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AltSonflex1-2-3

Biological

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

Menveo

Biological

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

Infanrix hexa

Biological

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

TYPHIBEV

Biological

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

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)

    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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Acronym: H06_04TP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.