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

May 12, 2017 updated by: GlaxoSmithKline

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

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8 different formulations of investigational NTHI vaccine in current and former smokers, 50-70 years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This Protocol Posting has been updated following Protocol Amendment 1, dated 10 October 2012, leading to a change in an inclusion criterion.

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2060
        • GSK Investigational Site
      • Gent, Belgium, 9000
        • GSK Investigational Site
      • Wilrijk, Belgium, 2610
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 without medical history, clinical finding or laboratory finding which in the opinion of the investigator could pose a safety concern or interfere with the protocol.
  • Current or former smokers.
  • A smoking history of at least 10 pack-years.
  • 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 vaccine, 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 not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine, with the exception of any influenza vaccine which may be administered ≥ 15 days preceding or following any study vaccine dose.
  • Previous vaccination with any vaccine containing NTHi-antigens.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of or current autoimmune disease.
  • Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% of predicted normal value.
  • Diagnosed with a respiratory disorder. Please note that subjects with mild pulmonary obstruction can be enrolled.
  • Laboratory evidence of clinically significant haematological abnormalities at Screening.
  • Acute disease and/or fever at the time of enrolment.
  • Current alcoholism and/or drug abuse.
  • Has significant disease, in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
  • History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
  • Has contraindication for spirometry testing.
  • Malignancies within previous 5 years and lymphoproliferative disorders.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any other condition that the investigator judges may interfere with study findings.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Subjects in this group will receive formulation 1 of NTHi vaccine.
Biological: NTHI vaccine GSK2838500A (formulation 1)
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Experimental: Group B
Subjects in this group will receive formulation 2 of NTHi vaccine.
Biological: NTHI vaccine GSK2838501A (formulation 2)
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Experimental: Group C
Subjects in this group will receive formulation 3 of NTHi vaccine.
Biological: NTHI vaccine GSK2838502A (formulation 3)
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Experimental: Group D
Subjects in this group will receive formulation 4 of NTHi vaccine.
Biological: NTHI vaccine GSK2838503A (formulation 4)
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Experimental: Group E
Subjects in this group will receive formulation 5 of NTHi vaccine and a placebo.
Biological: NTHI vaccine GSK2838504A (formulation 5)
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Experimental: Group F
Subjects in this group will receive formulation 6 of NTHi vaccine and a placebo.
Biological: NTHI vaccine GSK2838505A (formulation 6)
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Experimental: Group G
Subjects in this group will receive formulation 7 of NTHi vaccine and a placebo.
Biological: NTHI vaccine GSK2838508A (formulation 7)
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Experimental: Group H
Subjects in this group will receive formulation 8 of NTHi vaccine and a placebo.
Biological: NTHI vaccine GSK2838509A (formulation 8)
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Placebo Comparator: Group Placebo 1
Subjects in this group will receive placebo.
Drug: Placebo comparator
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Placebo Comparator: Group Placebo 2
Subjects in this group will receive placebo.
Drug: Placebo comparator
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of each solicited local and general adverse event (AE), in all subjects, in all groups.
Time Frame: During a 7-day follow-up period (from day 0 to day 6) after each vaccination.
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.
Time Frame: During a 30-day follow-up period (from day 0 to day 29) after each vaccination.
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.
Time Frame: Prior to each vaccination.
Prior to each vaccination.
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
Time Frame: 7 days after each vaccination.
7 days after each vaccination.
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
Time Frame: At study conclusion (Day 420).
At study conclusion (Day 420).
Occurrence of any serious adverse event (SAE), in all subjects, in all groups.
Time Frame: From first vaccination (Day 0) to study conclusion (Day 420).
From first vaccination (Day 0) to study conclusion (Day 420).
Occurrence of any potential immune-mediated disease (pIMD) in all subjects, in all groups.
Time Frame: From first vaccination (Day 0) to study conclusion (Day 420).
From first vaccination (Day 0) to study conclusion (Day 420).

Secondary Outcome Measures

Outcome Measure
Time Frame
Humoral immune response to the components of the NTHi vaccine formulations, in all subjects, in all groups, in terms of antibody concentrations.
Time Frame: Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).
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.
Time Frame: Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).
Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2012

Primary Completion (Actual)

January 30, 2014

Study Completion (Actual)

January 30, 2014

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

August 30, 2012

First Posted (Estimate)

September 5, 2012

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116647

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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