Recent Updates
Recently added Catalysts

altSonflex1-2-3 Dose A

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06663436A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in InfantsPHASE2 COMPLETED 200 — — Nov 13, 2024Oct 21, 2025Jan 30, 20261 Kenya
Unlock Drug Trial Details
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)
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range39 Weeks — 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
Unlock Eligibility Criteria