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DiarrhoeaPhase 2NCT06663436

A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants

A Phase 2 study testing altSonflex1-2-3 Dose A, altSonflex1-2-3 Dose B and altSonflex1-2-3 Dose C in people with Diarrhoea, run by GlaxoSmithKline at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants. The candidate vaccine, altSonflex1-2-3, is currently being evaluated in a Phase 2 age de-escalation (from least vulnerable adult population to most vulnerable paediatric… Read more about this study

Who is it for?
Ages 39 to 43 weeksHealthy volunteers can take part
Conditions the study is for
Diarrhoea
What is being tested?
altSonflex1-2-3 Dose A, altSonflex1-2-3 Dose B and altSonflex1-2-3 Dose C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteKenya
Study dates
13 Nov 2024to 21 Oct 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 39 to 43 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Participants' parent(s)/ Legally acceptable representative (LAR), who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
  • Healthy participants as established by medical history, clinical examination, and laboratory assessment.
  • Participants satisfying all screening requirements.
  • Participants seronegative for hepatitis B, and hepatitis C.
  • A male or female 9 months of age at the time of the first study intervention administration.
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  • Normal nutritional z-score.
  • Previously completed routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR(s).
  • Born at a gestation period of >=37 weeks to the best knowledge of the participant's parent(s)/LAR(s).
  • Participants negative for human immunodeficiency virus as confirmed by DNA polymerase chain reaction testing.
  • Participants negative for HLA-B27.

Who cannot join

  • Known exposure to Shigella during lifetime of the participant as confirmed during interview with the participant's parent(s)/LAR(s) or documented by participant's records.
  • Progressive, unstable, or uncontrolled clinical conditions.
  • History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
  • Major congenital defects, as assessed by the investigator.
  • Recurrent history or uncontrolled neurological disorders or seizures.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
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  • Hypersensitivity (known or suspected), including allergy, to medicinal products, vaccines, or medical equipment whose use is foreseen in this study.
  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
  • Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
  • Acute disease and/or fever (defined as temperature >=38.0°C) at the time of enrollment.
  • Any clinically significant hematological and/or biochemical laboratory abnormality.
  • Confirmed positive COVID-19 test during the period starting 30 days before the first administration of study interventions (Day -30 to Day 1).
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -30 to Day 1), or their planned use during the study period.
  • Planned administration/administration of a vaccine/product not foreseen by the Protocol in the period starting 21 days before the first dose and ending after the last dose of study intervention(s) administration with the exception of Coronavirus disease 2019 (COVID-19) vaccines and Expanded Program on Immunization (EPI) vaccines.
  • Administration of long-acting immune-modifying drugs at any time during the study period.
  • Prior receipt of an experimental Shigella vaccine or live Shigella challenge.
  • Prior receipt of a Typhoid conjugate vaccine (TCV).
  • Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, from birth or planned administration during the study period.
  • Chronic administration of immune-modifying drugs (defined as more than 14 days consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
  • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention drug or invasive medical device.
  • Any study personnel or immediate dependents, family, or household member.
  • Child in care.
  • Participants who do not meet eligibility criteria for administration of control vaccines.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • GSK Investigational Site

    Kericho, 20200

Other trials in Kenya

About this study

Official title: A Phase 2 Single-Blind, Randomized, Controlled, Single Center Study to Assess the Immunogenicity and Safety of a 2-Dose Schedule With GVGH altsonflex1-2-3 Vaccine in African Infants (H06_02TP)

This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants. The candidate vaccine, altSonflex1-2-3, is currently being evaluated in a Phase 2 age de-escalation (from least vulnerable adult population to most vulnerable paediatric population) clinical study in Kenya, with the aim of identifying a preferred dose, using a 3-dose vaccination schedule in infants from 9 months of age (NCT05073003). This Phase 2 clinical study will evaluate the safety and immunogenicity of an alternative 2-dose vaccination schedule.

Conditions
Diarrhoea
Being tested
altSonflex1-2-3 Dose A, altSonflex1-2-3 Dose B, altSonflex1-2-3 Dose C, TYPHIBEV, Infanrix hexa
Keywords
Shigella, Shigellosis, altSonflex1-2-3, Infants, African, Safety, Immunogenicity
Medical subject headings
Diarrhea, Dysentery, Bacillary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • altSonflex1-2-3 Dose ABiological

    Also called Shigella vaccine

    altSonflex1-2-3 Dose A administered intramuscularly on Day 1 and Day 169

  • altSonflex1-2-3 Dose BBiological

    Also called Shigella vaccine

    altSonflex1-2-3 Dose B administered intramuscularly on Day 1 and Day 169

  • altSonflex1-2-3 Dose CBiological

    Also called Shigella vaccine

    altSonflex1-2-3 Dose C administered intramuscularly on Day 1 and Day 169

  • TYPHIBEVBiological

    Also called Biological E. Limited's Typhoid Vi-CRM197 conjugate vaccine

    TYPHIBEV administered intramuscularly on Day 1

  • Infanrix hexaCombination product

    Also called GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated) and Haemophilus influenzae type b vaccine (adsorbed)

    Infanrix hexa administered intramuscularly on Day 169

  • MR-VACBiological

    Also called Serum Institute of India's Measles and rubella vaccine (live)

    MR-VAC co-administered subcutaneously on Day 1 and Day 169

Study groups in NCT06663436
Study groupRoleWhat they receive
altSonflex1-2-3 Low Dose GroupExperimentalParticipants received 2 low doses of altSonflex1-2-3 and 2 doses of the measles and rubella vaccine (MR-VAC) one each on Day 1 and Day 169.
Receives: Biological: altSonflex1-2-3 Dose A; Biological: MR-VAC
altSonflex1-2-3 Medium Dose GroupExperimentalParticipants received 2 medium doses of altSonflex1-2-3 and 2 doses of MR-VAC one each on Day 1 and Day 169.
Receives: Biological: altSonflex1-2-3 Dose B; Biological: MR-VAC
altSonflex1-2-3 High Dose GroupExperimentalParticipants received 2 high doses of altSonflex1-2-3 and 2 doses of MR-VAC one each on Day 1 and Day 169.
Receives: Biological: altSonflex1-2-3 Dose C; Biological: MR-VAC
Control GroupActive comparatorParticipants received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix Hexa vaccine on Day 169, along with 2 doses of MR-VAC on Day 1 and Day 169.
Receives: Biological: TYPHIBEV; Combination Product: Infanrix hexa; Biological: MR-VAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Shigella Lipopolysaccharide (LPS)/O-Antigen (OAg) Serum Immunoglobulin G (IgG)

    Anti-serotype specific Shigella LPS/OAg serum IgG GMCs were measured by enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL) of serum. S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes were tested.

    Measured: At Day 1 (before administration of Dose 1)

  2. GMCs of Anti-serotype Specific Shigella LPS/OAg Serum IgG

    Measured: At Day 29 (28 days after administration of Dose 1)

  3. GMCs of Anti-serotype Specific Shigella LPS/OAg Serum IgG

    Measured: At Day 169 (before administration of Dose 2)

  4. GMCs of Anti-serotype Specific Shigella LPS/OAg Serum IgG

    Measured: At Day 197 (28 days after administration of Dose 2)

  5. Number of Participants With at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG

    1. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes were tested.

    Measured: At Day 29 compared to baseline (before administration of Dose 1 on Day 1)

  6. Number of Participants With at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG

    Measured: At Day 197 compared to baseline (before administration of Dose 1 on Day 1)

  7. Number of Participants With at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG

    Measured: At Day 197 compared to pre-Dose 2 at Day 169

Secondary outcomes (12)

  1. Number of Participants With Solicited Administration Site Events

    The solicited administration site events assessed were erythema, pain and swelling.

    Measured: During the 7 days after each study intervention administration (study intervention administered at Day 1 and Day 169)

  2. Number of Participants With Solicited Systemic Events

    The solicited systemic event assessed was fever (pyrexia). Fever is defined as temperature ≥38.0°Celsius (C), measured axillary.

    Measured: During the 7 days after each study intervention administration (study interventions administered at Day 1 and Day 169)

  3. Number of Participants With Unsolicited Adverse Events (AEs)

    An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

    Measured: During the 28 days after each study intervention administration (study interventions administered at Day 1 and Day 169)

  4. Number of Participants With Serious AEs (SAEs)

    An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.

    Measured: Day 1 to Day 197

  5. Number of Participants With Change From Baseline in Hematological, Renal, and Hepatic Panel Test Results With Respect to Laboratory Reference Ranges at Day 8

    Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, blood urea, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Categories reported when comparing Day 1 (baseline) and laboratory reference range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

    Measured: Day 8 compared to baseline (pre-Dose 1 at Day 1)

  6. Number of Participants With Change From Baseline in Hematological, Renal, and Hepatic Panel Test Results With Respect to Laboratory Reference Ranges at Day 176

    Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, blood urea, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Categories reported when comparing Day 169 (baseline) and laboratory reference range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

    Measured: Day 176 compared to pre-Dose 2 at Day 169

  7. The Number of Participants With Abnormal Hematological, Renal, and Hepatic Panel Test Results by Grade Values at Day 8 Versus Baseline (Day 1) Grade Values

    Panel tests include measures of ALT, AST, creatinine, hemoglobin, neutrophils decrease, platelets decrease and white blood cells (WBC) decrease. Categories reported when comparing Day 1 (baseline) and laboratory reference range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at timing>, where Grade 0=within reference range, Grade 1= mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life threatening laboratory abnormality.

    Measured: Day 8 compared to baseline (before administration of Dose 1 at Day 1)

  8. The Number of Participants With Abnormal Hematological, Renal, and Hepatic Panel Test Results by Grade Values at Day 176 Versus Day 169 Grade Values

    Panel tests include measures of ALT, AST, creatinine, hemoglobin, neutrophils decrease, platelets decrease and white blood cells (WBC) decrease. Categories reported when comparing Day 169 and laboratory reference range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at timing>, where Grade 0=within reference range, Grade 1= mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life threatening laboratory abnormality.

    Measured: Day 176 compared to pre-Dose 2 at Day 169

  9. Anti-measles IgG Concentrations Expressed as GMCs

    Anti-measles IgG concentrations were expressed as GMCs in EU/mL.

    Measured: At Day 1 (before the first MR-VAC) and at Day 197 (28 days after the second MR-VAC vaccination)

  10. Anti-rubella IgG Concentrations Expressed as GMCs

    Anti-rubella IgG concentrations were expressed as GMCs in EU/mL.

    Measured: At Day 1 (before the first MR-VAC) and at Day 197 (28 days after the second MR-VAC vaccination)

  11. Number of Participants Achieving Anti-measles IgG Concentrations of ≥150 Milli International Units Per Milliliter (mIU/mL) and ≥200 mIU/mL

    Measured: At Day 197 (28 days after the second MR-VAC vaccination)

  12. Number of Participants Achieving Anti-rubella IgG Concentrations of ≥4 IU/mL and ≥10 IU/mL

    Measured: At Day 197 (28 days after the second MR-VAC vaccination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start13 Nov 2024
  3. Primary completion21 Oct 2025
  4. Study completion21 Oct 2025

Resources

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
Single blind
Who is masked
Participant
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06663436
Sponsor's protocol ID
219449
Status last verified
Jul 2026
First submitted
25 Oct 2024
Last updated
26 Oct 2026
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing altSonflex1-2-3 Dose A, altSonflex1-2-3 Dose B and altSonflex1-2-3 Dose C in people with Diarrhoea, run by GlaxoSmithKline at 1 site in Kenya.

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 11 inclusion and 25 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: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 26 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Shigella Lipopolysaccharide (LPS)/O-Antigen (OAg) Serum Immunoglobulin G (IgG) (time frame: At Day 1 (before administration of Dose 1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06663436.

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 26 Oct 2026.

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