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altSonflex1-2-3 Dose A

Phase 2

Diarrhoea | Monoclonal antibody | Gastrointestinal |GSK plc|Last Updated: Jan 30, 2026

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

altSonflex1-2-3 Dose A · 1 trial · 1 indication

Phase 2 1
NCT06663436A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in InfantsDiarrhoea
COMPLETED200 Analytics
PHASE2COMPLETED
A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants
Diarrhoea
NCT06663436200
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Study Endpoints

Primary Endpoints

Geometric mean titers (GMTs) of anti-serotype-specific Shigella lipopolysaccharides/O-antigen (LPS/OAg) serum Immunoglobulin G (IgG)
Day 1 (before administration of Dose 1)
GMTs of anti-serotype-specific Shigella LPS/OAg serum IgG
Day 169 (before administration of Dose 2)
Geometric mean concentrations (GMCs) of anti-serotype-specific Shigella LPS/OAg serum IgG
Day 1 (before administration of Dose 1)
GMCs of anti-serotype-specific Shigella LPS/OAg serum IgG
Day 169 (before administration of Dose 2)
Number of infants with at least a 4-fold increase in anti-serotype-specific Shigella LPS/OAg serum IgG
Day 29 compared with baseline (Day 1)

Secondary Endpoints

Number of infants with solicited administration-site events
During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 169)
Number of infants with solicited systemic events
During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 169)
Number of infants with unsolicited adverse events (AEs)
During 28 days after each study intervention administration (study interventions administered at Day 1 and Day 169)
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
altSonflex1-2-3 Dose_A GroupEXPERIMENTALParticipants randomized to receive altSonflex1-2-3 Dose A and MR-VAC on Day 1 and Day 169.
altSonflex1-2-3 Dose_B GroupEXPERIMENTALParticipants randomized to receive altSonflex1-2-3 Dose B and MR-VAC on Day 1 and Day 169.
altSonflex1-2-3 Dose_C GroupEXPERIMENTALParticipants randomized to receive altSonflex1-2-3 Dose C and MR-VAC on Day 1 and Day 169.
Control GroupACTIVE_COMPARATORParticipants randomized to receive TYPHIBEV on Day 1, Infanrix hexa on Day 169 and MR-VAC on Day 1 and Day 169.

Interventions

NameTypeDescription
altSonflex1-2-3 Dose ABIOLOGICALaltSonflex1-2-3 Dose A administered intramuscularly on Day 1 and Day 169
altSonflex1-2-3 Dose BBIOLOGICALaltSonflex1-2-3 Dose B administered intramuscularly on Day 1 and Day 169
altSonflex1-2-3 Dose CBIOLOGICALaltSonflex1-2-3 Dose C administered intramuscularly on Day 1 and Day 169
TYPHIBEVBIOLOGICALTYPHIBEV administered intramuscularly on Day 1
Infanrix hexaCOMBINATION_PRODUCTInfanrix hexa administered intramuscularly on Day 169
MR-VACBIOLOGICALMR-VAC co-administered subcutaneously on Day 1 and Day 169
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Eligibility Criteria

Age Range39 Weeks to 43 Weeks
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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 pri...

Countries:Kenya
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Frequently asked questions about altSonflex1-2-3 Dose A

What is altSonflex1-2-3 Dose A used for?

altSonflex1-2-3 Dose A is an investigational monoclonal antibody being developed for the prevention of diarrhoea, specifically shigellosis, in infants. It is currently in Phase 2 clinical development and has been studied in a completed trial in Kenya.

What does altSonflex1-2-3 Dose A target?

The specific molecular target of altSonflex1-2-3 Dose A is not disclosed in the available information. It is classified as a monoclonal antibody, but its precise antigen or pathway has not been specified.

Who makes altSonflex1-2-3 Dose A?

altSonflex1-2-3 Dose A is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this asset for the prevention of diarrhoea.

What phase is altSonflex1-2-3 Dose A in?

altSonflex1-2-3 Dose A is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with no active trials currently ongoing.

What clinical trials is altSonflex1-2-3 Dose A in?

altSonflex1-2-3 Dose A has been studied in one completed Phase 2 trial, NCT06663436, titled 'A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants'. The trial enrolled 200 participants in Kenya and was active-controlled.

Is altSonflex1-2-3 Dose A the same as a Shigella vaccine?

altSonflex1-2-3 Dose A is a monoclonal antibody, not a vaccine. The completed trial NCT06663436 evaluated a multicomponent Shigella vaccine, and altSonflex1-2-3 Dose A may have been tested as a comparator or adjunct, but the relationship is not explicitly defined in the available data.