Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00321763
First received: May 3, 2006
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.


Condition Intervention Phase
Influenza
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Biological: Fluarix TM
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate & Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate vs Fluarix™ Administered Intramuscularly in Elderly

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
    Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

  • Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

  • Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

  • Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

  • Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) post vaccination period ] [ Designated as safety issue: No ]
    Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post vaccination period ] [ Designated as safety issue: No ]
    Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.

  • Number of Subjects With New Onset of Chronic Diseases (NOCDs). [ Time Frame: From Day 0 to Day 180 ] [ Designated as safety issue: No ]
    NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.

  • Number of Subjects With Medically Significant Conditions (MSCs). [ Time Frame: From Day 0 to Day 180 ] [ Designated as safety issue: No ]
    MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.

  • Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). [ Time Frame: During the 30-day (Days 0-29) 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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.

  • Number of Subjects With Any and Related Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (Days 0-180) ] [ Designated as safety issue: No ]
    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 = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.


Enrollment: 3124
Study Start Date: April 2006
Study Completion Date: December 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1247446A Lot 1 Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
Experimental: GSK1247446A Lot 2 Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
Experimental: GSK1247446A Lot 3 Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
Experimental: GSK1247446A Pooled Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
Active Comparator: Fluarix Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Fluarix TM
Single dose, Intramuscular injection

Detailed Description:

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female age 60 years or older at the time of the vaccination.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • Written informed consent obtained from the subject.
  • Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
  • History of hypersensitivity to a previous dose of influenza vaccine.
  • History of confirmed influenza infection within the last 12 months.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
  • Acute disease at the time of enrolment
  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: NCT00321763

Locations
France
GSK Investigational Site
Caen cedex 4, France, 14052
GSK Investigational Site
Gières, France, 38610
GSK Investigational Site
Lagord, France, 17140
GSK Investigational Site
Lille, France, 59019
GSK Investigational Site
Montpellier Cedex 5, France, 34295
GSK Investigational Site
Paris, France, 75679
GSK Investigational Site
Poitiers, France, 86000
GSK Investigational Site
Rouen, France, 76100
GSK Investigational Site
Toulouse, France, 31300
Russian Federation
GSK Investigational Site
Ekaterinburg, Russian Federation, 620078
GSK Investigational Site
Kazan, Russian Federation, 420015
GSK Investigational Site
Saratov, Russian Federation, 410018
United Kingdom
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG2 7AG
GSK Investigational Site
Cardiff, Glamorgan, United Kingdom, CF14 5GJ
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G81 4SA
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
GSK Investigational Site
Edgbaston, Birmingham, United Kingdom, B15 2SQ
GSK Investigational Site
Manchester, United Kingdom, M15 6SX
GSK Investigational Site
Waterloo, Liverpool, United Kingdom, L22 0LG
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00321763     History of Changes
Other Study ID Numbers: 107192, 107214
Study First Received: May 3, 2006
Results First Received: March 21, 2013
Last Updated: July 18, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Influenza
Influenza vaccine

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

ClinicalTrials.gov processed this record on October 23, 2014