Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01626820
First received: June 21, 2012
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season.


Condition Intervention Phase
Influenza
Biological: Fluviral®
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine (GSK1536489A) Fluviral® (2012/2013 Season) in Adults Aged 18 Years and Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. [ Time Frame: At Day 0 and Day 21 ] [ Designated as safety issue: No ]
    Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.

  • Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. [ Time Frame: At Day 0 and Day 21 ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a subject with serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The influenza vaccine strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.

  • Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.

  • Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    MGI was defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).


Secondary Outcome Measures:
  • Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling were defined as ecchymosis, induration, redness and swelling above 100 millimeters (mm).

  • Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever [oral temperature ≥38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination, Any fever = oral temperature ≥38.0 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination

  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 21-day (Days 0-20) post-vaccination period. ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (Day 0 - Day 20 after vaccination). ] [ Designated as safety issue: No ]
    SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.


Enrollment: 113
Study Start Date: July 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluviral Adults Group
Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Biological: Fluviral®
1 dose administered intramuscularly in deltoid region of non-dominant arm at Day 0
Experimental: Fluviral Elderly Group
Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Biological: Fluviral®
1 dose administered intramuscularly in deltoid region of non-dominant arm at Day 0

  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.
  • A male or female 18 years of age and older at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination 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.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
  • Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period.
  • Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
  • Acute disease and/or fever at the time of enrolment.
  • Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Insulin-dependent diabetes mellitus.
  • Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
  • A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
  • History of chronic alcohol abuse and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
  • Any known or suspected allergy to any constituent of Fluviral® and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
  • A history of severe adverse reaction to a previous influenza vaccination.
  • Pregnant and/or lactating/nursing female.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626820

Locations
Canada, Quebec
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01626820     History of Changes
Other Study ID Numbers: 116664
Study First Received: June 21, 2012
Results First Received: August 8, 2013
Last Updated: August 8, 2013
Health Authority: Canada: Biologics and Genetic Therapies Directorate (BGTD)

Keywords provided by GlaxoSmithKline:
Immunogenicity
Influenza
Safety
Adults
Fluviral

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

ClinicalTrials.gov processed this record on April 14, 2014