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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01657526
First received: August 2, 2012
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Respiratory Disorders
Biological: GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)
Biological: GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)
Biological: Saline placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, 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 Healthy Adults

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of solicited local and general adverse event (AE), in all subjects, in all vaccine groups [ Time Frame: During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of any unsolicited AE, in all subjects, in all vaccine groups [ Time Frame: During a 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all vaccine groups [ Time Frame: At baseline (Screening visit) and after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of any serious adverse event (SAE), in all subjects, in all vaccine groups [ Time Frame: From first vaccination to study conclusion (Day 420). ] [ Designated as safety issue: No ]
  • Occurrence of any potential Immune-Mediated Disease (pIMDs) in all subjects, in all vaccine groups [ Time Frame: From first vaccination to study conclusion (Day 420). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Humoral immune response to components of the NTHi vaccine formulations, in all subjects, in all vaccine groups [ Time Frame: Prior to each vaccination and 30 days post each vaccination. ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: August 2012
Study Completion Date: November 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 1 of the study
Biological: GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)
Administered intramuscularly (IM) in the deltoid region of non-dominant arm
Placebo Comparator: Group B
Subjects in this group will receive placebo in Step 1 of the study
Biological: Saline placebo
2 doses administered IM in the deltoid region of non-dominant arm
Experimental: Group C
Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 2 of the study
Biological: GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)
2 doses administered IM in the deltoid region of non-dominant arm
Placebo Comparator: Group D
Subjects in this group will receive placebo in Step 2 of the study
Biological: Saline placebo
2 doses administered IM in the deltoid region of non-dominant arm

  Eligibility

Ages Eligible for Study:   18 Years to 40 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.
  • 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.
  • History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
  • Malignancies within previous 5 years (excluding non-melanic skin cancer) and lymphoproliferative disorders.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • History of chronic alcohol consumption and/or drug abuse.
  • 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: NCT01657526

Locations
Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01657526     History of Changes
Other Study ID Numbers: 116018
Study First Received: August 2, 2012
Last Updated: December 12, 2013
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Healthy adults
Safety
Reactogenicity
Immunogenicity
Non-typeable H. Influenzae (NTHi)

Additional relevant MeSH terms:
Influenza, Human
Respiration Disorders
Respiratory Tract Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 20, 2014