DiarrhoeaPhase 2H06_04TPNCT07320716
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
A Phase 2 study testing AltSonflex1-2-3, Menveo and Infanrix hexa in people with Diarrhoea, run by GlaxoSmithKline.
Trial 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]). Read more about this study
- Who is it for?
- Ages 26 to 55 monthsHealthy volunteers can take part
- Conditions the study is for
- Diarrhoea
- What is being tested?
- AltSonflex1-2-3, Menveo and Infanrix hexa
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2026to 31 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 55 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Diarrhoea
- Being tested
- AltSonflex1-2-3, Menveo, Infanrix hexa, TYPHIBEV
- Keywords
- Shigella sonnei, Shigella flexneri, Shigella vaccine, altSonflex1-2-3, Shigelllosis
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AltSonflex1-2-3Biological
Also called GSK's Shigella vaccine
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.
MenveoBiological
Also called GSKs Meningococcal A, C, Y and W-135 conjugate vaccine
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.
Infanrix hexaBiological
Also called GSKs Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine
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.
TYPHIBEVBiological
Also called Biological E. Limiteds Typhoid Vi-CRM197 conjugate vaccine
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.
| Study group | Role | What they receive |
|---|---|---|
| H06_01TP Study_Infants_Selected dose | Experimental | 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. Receives: Biological: AltSonflex1-2-3 |
| H06_01TP Study_ ST2_Infants_Control | Active 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. Receives: Biological: Menveo; Biological: Infanrix hexa |
| H06_02TP Study_Infants_Selected dose | Experimental | Infants who received 2 doses of the altSonflex1-2-3 vaccine on Day 1 and Day 169 in the H06_02TP parent study. Receives: Biological: AltSonflex1-2-3 |
| H06_02TP Study_ Infants_Control | Active 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. Receives: Biological: Infanrix hexa; Biological: TYPHIBEV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA)
- sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.
Measured: 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
- sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.
Measured: 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
- sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.
Measured: At Visit 3 of the current study (36 months after last vaccination in the parent studies)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start2 Jan 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrhoeaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320716
- Sponsor's protocol ID
- 223136
- Acronym
- H06_04TP
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07320716
- Acronym / sponsor ID
- H06_04TP / 223136
- Conditions
- Diarrhoea
- Keywords
- Shigella sonnei, Shigella flexneri, Shigella vaccine, altSonflex1-2-3, Shigelllosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| H06_01TP Study_Infants_Selected dose | Experimental | Biological: AltSonflex1-2-3Infants 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_Control | Active comparator | Biological: Menveo, Biological: Infanrix hexaInfants 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 dose | Experimental | Biological: AltSonflex1-2-3Infants 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_Control | Active comparator | Biological: Infanrix hexa, Biological: TYPHIBEVInfants 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. |
Who may qualify
- Ages
- 26 to 55 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AltSonflex1-2-3Also: GSK's Shigella vaccineNo 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. | Biological | H06_01TP Study_Infants_Selected dose, H06_02TP Study_Infants_Selected dose |
| MenveoAlso: GSKs Meningococcal A, C, Y and W-135 conjugate vaccineNo 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. | Biological | H06_01TP Study_ ST2_Infants_Control |
| Infanrix hexaAlso: GSKs Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccineNo 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. | Biological | H06_01TP Study_ ST2_Infants_Control, H06_02TP Study_ Infants_Control |
| TYPHIBEVAlso: Biological E. Limiteds Typhoid Vi-CRM197 conjugate vaccineNo 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. | Biological | H06_02TP Study_ Infants_Control |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AltSonflex1-2-3, Menveo and Infanrix hexa in people with Diarrhoea, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.