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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01678677
First received: August 23, 2012
Last updated: August 28, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Respiratory Disorders
Biological: NTHI vaccine GSK2838500A (formulation 1)
Biological: NTHI vaccine GSK2838501A (formulation 2)
Biological: NTHI vaccine GSK2838502A (formulation 3)
Biological: NTHI vaccine GSK2838503A (formulation 4)
Biological: NTHI vaccine GSK2838504A (formulation 5)
Biological: NTHI vaccine GSK2838505A (formulation 6)
Biological: NTHI vaccine GSK2838508A (formulation 7)
Biological: NTHI vaccine GSK2838509A (formulation 8)
Drug: Placebo comparator
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups. [ Time Frame: Prior to each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups. [ Time Frame: 7 days after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups. [ Time Frame: At study conclusion (Day 420). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]

Enrollment: 272
Study Start Date: August 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678677

Locations
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2060
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01678677     History of Changes
Other Study ID Numbers: 116647
Study First Received: August 23, 2012
Last Updated: August 28, 2014
Health Authority: Belgium: Ministry of Health

Keywords provided by GlaxoSmithKline:
non-typeable Haemophilus influenzae
immunogenicity
reactogenicity
safety

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 30, 2014