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Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine

An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Healthy Adults

NCT01657526•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.

Eligibility

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

Yes

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 subjects as established by medical history, physical examination and laboratory assessment before entering into the study.
•Female subjects of non-childbearing potential may be enrolled in the study.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
•* has practiced adequate contraception for 30 days prior to vaccination, and
•* has a negative pregnancy test on the day of vaccination, and
•* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria

•Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
•Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before the first vaccine dose and ending 30 days after the last dose of vaccines.
•Previous vaccination with a vaccine containing NTHi antigens.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or equivalent. Topical steroids are allowed.
•Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccines or planned administration during the study period.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•Laboratory evidence of clinically significant haematological (complete blood cell count \[Red Blood Cells (RBC), White Blood Cells (WBC)\], WBC differential count, platelets count and haemoglobin level) and biochemical (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], creatinine and lactate dehydrogenase \[LDH\]) abnormalities as per the opinion of the investigator based on the local laboratory normative data.
•Acute disease and/or fever at the time of enrolment.
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
+6 more criteria

Locations (1)

GSK Investigational Site

Adelaide, South Australia, Australia

Key Dates

Start Date

August 8, 2012

Primary Completion Date

November 25, 2013

Completion Date

November 25, 2013

Last Updated

May 15, 2017

Enrollment

ACTUAL participants

Conditions

Respiratory Disorders

Interventions

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

BIOLOGICAL

GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)

BIOLOGICAL

Saline placebo

BIOLOGICAL

Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults

NCT02272049

Respiratory Disorders

View study

COMPLETEDPHASE2

A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.

NCT03281876

Respiratory Disorders

View study

COMPLETEDNA

Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine

Inclusion Criteria

Exclusion Criteria

Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults

A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.

Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly

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