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NTHI vaccine GSK2838500A

Phase 1

Respiratory Disorders | Vaccine | Respiratory |GSK plc|Trials Updated: May 15, 2017

NTHI vaccine GSK2838500A target and mechanism

ModalityVaccine

Also known as NTHI vaccine GSK2838500A (formulation 1)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment272

FDA Designations

No designations recorded

NTHI vaccine GSK2838500A clinical trials

NTHI vaccine GSK2838500A · 1 trial · 1 indication

Phase 1 1
NCT01678677A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former SmokersRespiratory Disorders
COMPLETED272 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former Smokers
Respiratory DisordersUnlock trial analytics

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).
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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.
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Eligibility Criteria

Age Range50 Years to 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
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Competitive Landscape -Respiratory Disorders 11 trials

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Frequently asked questions about NTHI vaccine GSK2838500A

What is NTHI vaccine GSK2838500A?

NTHI vaccine GSK2838500A is an investigational vaccine developed by GSK plc for respiratory disorders. It is designed to target non-typeable Haemophilus influenzae (NTHi), a bacterium associated with respiratory infections. The vaccine is in Phase 1 clinical development and has been studied in current and former smokers.

What is NTHI vaccine GSK2838500A used for?

NTHI vaccine GSK2838500A is being developed for the prevention of respiratory disorders associated with non-typeable Haemophilus influenzae (NTHi). It is intended for use in adults, particularly current and former smokers aged 50 years and older, who are at risk of respiratory infections.

Who is developing NTHI vaccine GSK2838500A?

NTHI vaccine GSK2838500A is being developed by GSK plc, a global pharmaceutical company. GSK plc is listed on the New York Stock Exchange under the ticker symbol GSK. The company is responsible for the research and clinical development of this investigational vaccine.

What phase is NTHI vaccine GSK2838500A in?

NTHI vaccine GSK2838500A is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently approved for any indication. As an investigational vaccine, it remains under clinical evaluation for safety, reactogenicity, and immunogenicity.

What clinical trials is NTHI vaccine GSK2838500A in?

NTHI vaccine GSK2838500A has been evaluated in a single Phase 1 clinical trial, NCT01678677. This completed trial enrolled 272 participants in Belgium to assess the safety, reactogenicity, and immunogenicity of the vaccine in current and former smokers aged 50 years and older.

Is NTHI vaccine GSK2838500A the same as NTHI vaccine GSK2838500A (formulation 1)?

Yes, NTHI vaccine GSK2838500A is also known as NTHI vaccine GSK2838500A (formulation 1). The parenthetical designation distinguishes this specific formulation from other potential formulations. Both names refer to the same investigational vaccine developed by GSK plc for respiratory disorders.