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GSK Biologicals' Non-Typeable H. influenzae

Phase 1

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

Target and mechanism

ModalityMonoclonal antibody

Also known as GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

GSK Biologicals' Non-Typeable H. influenzae · 1 trial · 1 indication

Phase 1 1
NCT01657526Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) VaccineRespiratory Disorders
COMPLETED48 Analytics
PHASE1COMPLETED
Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine
Respiratory Disorders
NCT0165752648
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Study Endpoints

Primary Endpoints

Occurrence of solicited local and general adverse event (AE), in all subjects, in all vaccine groups
During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccination.
Occurrence of any unsolicited AE, in all subjects, in all vaccine groups
During a 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after each vaccination.
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all vaccine groups
At baseline (Screening visit) and after each vaccination.
Occurrence of any serious adverse event (SAE), in all subjects, in all vaccine groups
From first vaccination to study conclusion (Day 420).
Occurrence of any potential Immune-Mediated Disease (pIMDs) in all subjects, in all vaccine groups
From first vaccination to study conclusion (Day 420).

Secondary Endpoints

Humoral immune response to components of the NTHi vaccine formulations, in all subjects, in all vaccine groups
Prior to each vaccination and 30 days post each vaccination.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALSubjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 1 of the study
Group BPLACEBO_COMPARATORSubjects in this group will receive placebo in Step 1 of the study
Group CEXPERIMENTALSubjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 2 of the study
Group DPLACEBO_COMPARATORSubjects in this group will receive placebo in Step 2 of the study

Interventions

NameTypeDescription
GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)BIOLOGICALAdministered intramuscularly (IM) in the deltoid region of non-dominant arm
GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)BIOLOGICAL2 doses administered IM in the deltoid region of non-dominant arm
Saline placeboBIOLOGICAL2 doses administered IM in the deltoid region of non-dominant arm
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * A male or female between, and including, 18 and 40 years of age at the time of the first vaccination. * Healthy ...

Countries:Australia
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Competitive Landscape -Respiratory Disorders 8 trials

CompanyTickerTrialsLead PhaseDrugs
United Therapeutics CorporationUTHR2PHASE3Ralinepag
AstraZeneca PLCAZN2 - Undisclosed
Intuitive Surgical, Inc.ISRG1 - Undisclosed
Creative Medical Technology Holdings, Inc.CELZ1 - Undisclosed
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