A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01607112
First received: May 24, 2012
Last updated: November 14, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).


Condition Intervention Phase
Influenza
Biological: Fluarix/Influsplit SSW 2012-2013
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza 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 strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).

  • Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. [ Time Frame: At Day 0 and Day 21 ] [ Designated as safety issue: No ]
    Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.

  • Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    A seroconverted subjects was defined as a vaccinee with 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.

  • Mean Geometric Increase (MGI) for Haemagglutination Inhibition (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 GMT post-vaccination compared to Day 0.

  • Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    SPP was defined as the number of vaccinees with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.


Secondary Outcome Measures:
  • Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza 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 strains included H1N1, H3N2 and Yamagata antigens. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged greater than (>) 60 years.

  • Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. [ Time Frame: At Day 0 and Day 21 ] [ Designated as safety issue: No ]
    Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40. The outcome measure was assessed by the influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.

  • Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    SCR was defined as the number of vaccinees with 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 4-fold increase in post-vaccination titer. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.

  • Mean Geometric Increase (MGI) for Haemagglutination Inhibition (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 GMT post-vaccination compared to Day 0. This outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.

  • Duration of Solicited Local Symptoms. [ Time Frame: During the 4-day follow-up period (Days 0-3) after vaccination ] [ Designated as safety issue: No ]
    Duration was defined as number of days with any grade of local symptoms.

  • Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.

  • Duration of Solicited General Symptoms. [ Time Frame: During the 4-day follow-up period (Days 0-3) after vaccination ] [ Designated as safety issue: No ]
    Duration was defined as number of days with any grade of general symptoms.

  • Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: During the 4-day follow-up period (Day 0-3) after vaccination ] [ Designated as safety issue: No ]

    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 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 above 39.0°C


  • Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). [ Time Frame: During the 21-day follow-up period (Days 0-20) after vaccination ] [ 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. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.

  • Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (Days 0-21) ] [ Designated as safety issue: No ]
    A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing 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: 119
Study Start Date: July 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluarix/Influsplit 18-60 Years Group
Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Biological: Fluarix/Influsplit SSW 2012-2013
1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
Experimental: Fluarix/Influsplit > 60 Years Group
Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Biological: Fluarix/Influsplit SSW 2012-2013
1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm

  Eligibility

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

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • A male or female aged 18 years or above at the time of vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering 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 vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
  • Administration of an influenza vaccine within the six months preceding the study vaccination.
  • Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire 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.
  • Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Chronic underlying disease, not stabilized or clinically serious.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of Guillain-Barré syndrome.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Anaphylaxis following the administration of vaccine(s).
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
  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: NCT01607112

Locations
Germany
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
GSK Investigational Site
Dresden, Sachsen, Germany, 01099
GSK Investigational Site
Dresden, Sachsen, Germany, 01309
GSK Investigational Site
Dresden, Sachsen, Germany, 01129
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01607112     History of Changes
Other Study ID Numbers: 116663, 2012-000789-39
Study First Received: May 24, 2012
Results First Received: July 25, 2013
Last Updated: November 14, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Influenza
Healthy
Immunogenicity
Elderly
Safety
Adults

ClinicalTrials.gov processed this record on October 21, 2014