Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01204671
First received: September 16, 2010
Last updated: November 21, 2013
Last verified: September 2013
  Purpose

This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.


Condition Intervention Phase
Influenza
Biological: Influenza vaccine GSK2321138A
Biological: FluarixTM
Biological: Influenza vaccine GSK2604409A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease [ Time Frame: At Day 0 (D0), and at Day 21 (D21) ] [ Designated as safety issue: No ]
    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

  • Number of Seroconverted Subjects Against 4 Strains of Influenza Disease [ Time Frame: At Day 21 (D21) ] [ Designated as safety issue: No ]
    A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer < 1:10 and a post-vaccination titer above or equal (>=) 1:40, or a pre-vaccination HI antibody titer >= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.


Secondary Outcome Measures:
  • Number of Seropositive Subjects Against 4 Strains of Influenza Disease [ Time Frame: At Day 0 (D0), and at Day 21 (D21) ] [ Designated as safety issue: No ]
    A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

  • Number of Seroprotected Subjects Against 4 Strains of Influenza Disease [ Time Frame: At Day 0 (D0), and at Day 21 (D21) ] [ Designated as safety issue: No ]
    A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

  • Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease [ Time Frame: At Day 21 (D21) ] [ Designated as safety issue: No ]
    Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using "fold increase" as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms. [ Time Frame: Within the 7-day (Days 0-6) follow-up period after vaccination ] [ Designated as safety issue: No ]
    Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

  • Number of Days With Solicited Local Symptoms [ Time Frame: Within the 7-day (Days 0-6) follow-up period after vaccination ] [ Designated as safety issue: No ]
    Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within the 7-day (Days 0-6) follow-up period after vaccination ] [ Designated as safety issue: No ]
    Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C)]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature > 39°C. Related = symptom assessed as causally related to study vaccination.

  • Number of Days With Solicited General Symptoms [ Time Frame: Within the 7-day (Days 0-6) follow-up period after vaccination ] [ Designated as safety issue: No ]
    Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [defined as axillary temperature above or equal to (> =) 37.5 degrees Celsius (°C)].

  • Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Within the 21-day (Days 0-20) follow-up period after vaccination ] [ Designated as safety issue: No ]
    Unsolicited AEs cover 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination.

  • Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) [ Time Frame: From the beginning of the study (Day 0) to study end (Day 180) ] [ Designated as safety issue: No ]
    Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

  • Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) [ Time Frame: From the beginning of the study (Day 0) to study end (Day 180) ] [ Designated as safety issue: No ]
    Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

  • Number of Subjects With Any and Related Serious Adverse Events (SAEs) [ Time Frame: From the beginning of the study (Day 0) to study end (Day 180) ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination.


Enrollment: 4659
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK2321138A Lot 1 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
Biological: Influenza vaccine GSK2321138A
One intramuscular injection
Experimental: GSK2321138A Lot 2 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
Biological: Influenza vaccine GSK2321138A
One intramuscular injection
Experimental: GSK2321138A Lot 3 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
Biological: Influenza vaccine GSK2321138A
One intramuscular injection
Active Comparator: Fluarix Group
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
Biological: FluarixTM
One intramuscular injection
Active Comparator: GSK2604409A Group
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
Biological: Influenza vaccine GSK2604409A
One intramuscular injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female 18 years of age or older at the time of the first vaccination
  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Healthy subjects or those with chronic well-controlled disease as established by physical 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 urine 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 vaccine within 30 days preceding the dose of the study vaccine or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
  • Administration of an influenza vaccine during the 6 months preceding entry into the study.
  • Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21.
  • Any contra-indication to intramuscular administration of the influenza vaccines.
  • History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • 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 Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study
  • Pregnant or lactating female.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204671

  Show 42 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01204671     History of Changes
Other Study ID Numbers: 114269
Study First Received: September 16, 2010
Results First Received: December 13, 2012
Last Updated: November 21, 2013
Health Authority: Romania: Ministry of Health and Family
Germany: German Federal Ministry of Health
United States: Food and Drug Administration
Spain:Agencia Espanola de Medicamentos y Productos Sanitarios
Taiwan: Department of Health (DOH)
Korea: Korea Food & Drug Administration

Keywords provided by GlaxoSmithKline:
influenza infection
GSK Biologicals influenza vaccine GSK2321138A

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 16, 2014