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Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01788228
First received: January 31, 2013
Last updated: October 16, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals' vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of exposure to the virus.


Condition Intervention Phase
Influenza
Biological: GSK1557484A vaccine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Tolerability of GSK 1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of solicited local and general symptoms overall and by age category (18-40; 41-64; 18-64; and >64 years of age) [ Time Frame: During a 7-day follow-up period (Days 0-6) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events overall and by age category (18-40; 41-64; 18-64; and >64 years of age) [ Time Frame: Within 21 days after each vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the quality of life measures overall and by age category (18-40; 41-64; 18-64; and >64 years of age) via SF-36v2® health assessment questionnaires [ Time Frame: Day 0 and Day 7, Day 21 and Day 28 for weekly SF-36v2 questionnaires and Day 0 to Day 7 for daily SF-36v2 questionnaires ] [ Designated as safety issue: No ]
  • Assessment of psychometric validity and internal consistency of the daily SF-36v2 questionnaire [ Time Frame: Day 0 to Day 7 for daily SF-36v2 questionnaires ] [ Designated as safety issue: No ]
  • Occurrence and relationship to vaccination of MAEs, pIMDs, SAEs and adverse pregnancy outcomes [ Time Frame: During the entire study period (i.e. Day 0- Day 385) ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: April 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1557484A vaccine Group
Two doses given intramuscularly (IM) at a 21 day interval.
Biological: GSK1557484A vaccine
Subjects will receive 2 doses of GSK1557484A vaccine, administered as intramuscular (IM) injections at the Day 0 and Day 21 visits.

  Eligibility

Ages Eligible for Study:   18 Years and older
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.
  • Male or female adults ≥18 years of age at time of first study vaccination.
  • Written informed consent obtained from the subject.
  • Subjects who are at risk of occupational exposure to H5N1 influenza viruses based on exposure, or potential exposure during either (a) laboratory operations with live H5N1 virus, (b) production of H5N1 vaccines, or (c) conduct of epidemiological investigations of H5N1 cases.
  • Stable health status as defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 30 days prior to enrollment.
  • Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if they have practiced adequate contraception for 30 days prior to vaccination, and have a negative pregnancy test on the day of vaccination, and agree to practice adequate contraception for two months following the last dose of vaccine.

Exclusion Criteria:

  • Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Presence of a temperature ≥ 38.0ºC (≥100.4ºF) or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.

NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.

  • Significant risk of complications from intramuscular injections due to disorder of coagulation. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible. Assessment of risk of injection complications should be made in the context of individual subject risk of H5N1 virus infection.
  • An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.
  • Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine.
  • Planned administration of any vaccine other than the study vaccine before Day 42.
  • Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result before the first vaccination.
  • Lactating or nursing women.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
  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: NCT01788228

Locations
United States, Georgia
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
United States, Maryland
GSK Investigational Site
Rockville, Maryland, United States, 20850
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98105
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01788228     History of Changes
Other Study ID Numbers: 116861
Study First Received: January 31, 2013
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
H5N1
Occupational exposure
Influenza
Vaccine

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

ClinicalTrials.gov processed this record on November 27, 2014