Recent Updates
Recently added Catalysts

NTHI vaccine GSK2838500A

Phase 1

Respiratory Disorders | Monoclonal antibody | Other |GSK plc|Last Updated: May 15, 2017

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment272
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01678677A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former SmokersPHASE1 COMPLETED 272 — — Aug 31, 2012Jan 30, 2014May 15, 20173 Belgium
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Occurrence of each solicited local and general adverse event (AE), in all subjects, in all groups.
During a 7-day follow-up period (from day 0 to day 6) after each vaccination.
Occurrence of any unsolicited AE, in all subjects, in all groups.
During a 30-day follow-up period (from day 0 to day 29) after each vaccination.
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
Prior to each vaccination.
Occurrence of any serious adverse event (SAE), in all subjects, in all groups.
From first vaccination (Day 0) to study conclusion (Day 420).
Occurrence of any potential immune-mediated disease (pIMD) in all subjects, in all groups.
From first vaccination (Day 0) to study conclusion (Day 420).
Secondary Endpoints
Humoral immune response to the components of the NTHi vaccine formulations, in all subjects, in all groups, in terms of antibody concentrations.
Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).
Cell-mediated immune (CMI) responses to components of the NTHi vaccine formulations, in a sub-cohort of subjects, in all groups.
Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTALSubjects in this group will receive formulation 1 of NTHi vaccine.
Group BEXPERIMENTALSubjects in this group will receive formulation 2 of NTHi vaccine.
Group CEXPERIMENTALSubjects in this group will receive formulation 3 of NTHi vaccine.
Group DEXPERIMENTALSubjects in this group will receive formulation 4 of NTHi vaccine.
Group EEXPERIMENTALSubjects in this group will receive formulation 5 of NTHi vaccine and a placebo.
Group FEXPERIMENTALSubjects in this group will receive formulation 6 of NTHi vaccine and a placebo.
Group GEXPERIMENTALSubjects in this group will receive formulation 7 of NTHi vaccine and a placebo.
Group HEXPERIMENTALSubjects in this group will receive formulation 8 of NTHi vaccine and a placebo.
Group Placebo 1PLACEBO_COMPARATORSubjects in this group will receive placebo.
Group Placebo 2PLACEBO_COMPARATORSubjects in this group will receive placebo.
Interventions
NameTypeDescription
NTHI vaccine GSK2838500A (formulation 1)BIOLOGICALIntramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
NTHI vaccine GSK2838501A (formulation 2)BIOLOGICALIntramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
NTHI vaccine GSK2838502A (formulation 3)BIOLOGICALIntramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
NTHI vaccine GSK2838503A (formulation 4)BIOLOGICALIntramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
NTHI vaccine GSK2838504A (formulation 5)BIOLOGICALIntramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
NTHI vaccine GSK2838505A (formulation 6)BIOLOGICALIntramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
NTHI vaccine GSK2838508A (formulation 7)BIOLOGICALIntramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
NTHI vaccine GSK2838509A (formulation 8)BIOLOGICALIntramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Placebo comparatorDRUGIntramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Unlock Study Design Details
Eligibility Criteria
Age Range50 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female between, and including, 50 and 70 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Subjects...

Countries:Belgium
Unlock Eligibility Criteria
Competitive Landscape -Respiratory Disorders 9 trials
CompanyTickerTrialsLead PhaseDrugs
United Therapeutics CorporationUTHR2PHASE3Ralinepag, Treprostinil
AstraZeneca PLCAZN2 — Undisclosed
Intuitive Surgical, Inc.ISRG1 — Undisclosed
Masimo CorporationMASI1NAUndisclosed
Creative Medical Technology Holdings, Inc.CELZ1 — Undisclosed
Unlock Competitive Intelligence