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

NCT01788228 | Completed Phase 3 Results

• 1 other identifier: 116861
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Influenza; Influenza Vaccines

Keywords

Vaccine; Occupational exposure; Influenza; H5N1

Outcome Measures

Primary Outcomes (3)

• Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).

  Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.

  During a 7-day follow-up period (Days 0-6) after each vaccination

• Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).

  Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, muscle ache, shivering, sweating and fever \[oral temperature above 38.0 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39.0°C and ≤40°C.

  During a 7-day follow-up period (Days 0-6) after each vaccination

• Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age)

  Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Related was defined as an unsolicited symptom assessed as causally related to the study vaccination.

  During the 21-day (Days 0-20 post dose 1 and Days 21-41 post dose 2) post-vaccination period

Secondary Outcomes (14)

• Number of Subjects Reporting Any or Related Medically Attended Adverse Events (MAEs)

  During the entire study period (Day 0 to Day 385)

• Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs)

  During the entire study period (Day 0 to Day 385)

• Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)

  During the entire study period (Day 0 to Day 385)

• Number of Subjects With Reported Adverse Pregnancy Outcomes

  During the entire study period (Day 0 to Day 385)

• Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores

  Day 0 (baseline) and at each day from Day 1 to Day 7 post first vaccine dose

Study Arms (2)

Influenza A (H5N1) Virus monovalent vaccine 18-64 Years Group

EXPERIMENTAL

Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.

Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)

Influenza A (H5N1) Virus monovalent vaccine > 64 Years Group

EXPERIMENTAL

Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.

Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)

Interventions

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) BIOLOGICAL

2 doses administered intramuscularly (IM) in deltoid region of arm at the Day 0 and Day 21 visits.

Also known as: GSK1557484A vaccine

Influenza A (H5N1) Virus monovalent vaccine 18-64 Years Group; Influenza A (H5N1) Virus monovalent vaccine > 64 Years Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Stockbridge, Georgia, 30281, United States

Location

GSK Investigational Site

Rockville, Maryland, 20850, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53715, United States

Location

Related Publications (1)

• 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.

  PMID: 31060567 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 11, 2013
• Study Start: March 22, 2013
• Primary Completion: March 27, 2014
• Study Completion: February 25, 2015
• Last Updated: June 23, 2020
• Results First Posted: April 7, 2015

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (3)