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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
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: NCT01204671

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

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014