Clinical trial NCT01788228: Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
Official title: Safety and Tolerability of GSK 1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Influenza Vaccines
Keywords: Vaccine
Occupational exposure
Influenza
H5N1
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
timeFrame: During a 7-day follow-up period (Days 0-6) after each vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
timeFrame: During a 7-day follow-up period (Days 0-6) after each vaccination
measure: Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age)
timeFrame: During the 21-day (Days 0-20 post dose 1 and Days 21-41 post dose 2) post-vaccination period
Secondary outcomes:
measure: Number of Subjects Reporting Any or Related Medically Attended Adverse Events (MAEs)
timeFrame: During the entire study period (Day 0 to Day 385)
measure: Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs)
timeFrame: During the entire study period (Day 0 to Day 385)
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Day 0 to Day 385)
measure: Number of Subjects With Reported Adverse Pregnancy Outcomes
timeFrame: During the entire study period (Day 0 to Day 385)
measure: Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
timeFrame: Day 0 (baseline) and at each day from Day 1 to Day 7 post first vaccine dose
measure: Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
timeFrame: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)
measure: Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores (Physical and Mental)
timeFrame: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)
measure: Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores
timeFrame: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)
measure: Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
timeFrame: Day 0 (baseline) and at each day from Day 1 to Day 7 post first vaccine dose
measure: Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
timeFrame: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)
measure: Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
timeFrame: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)
measure: Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
timeFrame: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)
measure: Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
timeFrame: During the 7 days after Dose 1
measure: Quantitative Differences Between SF-36v2 Questionnaire Responses, and the Solicited Local and General Adverse Event Data Provided on Diary Cards
timeFrame: After the first and second vaccine doses
Other outcomes:
Locations:
city: Stockbridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Rockville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Standaert B, Dort T, Linden J, Madan A, Bart S, Chu L, Hayney MS, Kosinski M, Kroll R, Malak J, Meier G, Segall N, Schuind A. Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03A-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study. Health Qual Life Outcomes. 2019 May 6;17(1):80. doi: 10.1186/s12955-019-1147-4.