Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363077
First received: August 7, 2006
Last updated: May 16, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above


Condition Intervention Phase
Influenza
Biological: GSK1247446A Group
Biological: Fluarix™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ (GlaxoSmithKline Biologicals) Administered Intramuscularly in Elderly Aged 60 Years and Older.

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/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.

  • 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 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

  • Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. [ Time Frame: At Day 0 and Day 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 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

  • 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 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.


Secondary Outcome Measures:
  • Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
    The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).

  • Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
    The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).

  • 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 considered to be related to 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 [axillary 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 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 everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.

  • Number of Subjects With Any and Related Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (from Day 0 to Day 29) ] [ 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. Related = SAE considered by the investigator to have a causal relationship to study vaccination.


Enrollment: 150
Study Start Date: October 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1247446A Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: GSK1247446A Group
Low dose influenza vaccine adjuvanted with AS03 compared
Other Name: Low dose adjuvanted influenza vaccine
Active Comparator: Fluarix Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Fluarix™
GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.

  Eligibility

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

Inclusion Criteria:

  • Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
  • A male or female 60 years or older at the time of the first vaccination.
  • Free of obvious health problems

Exclusion Criteria:

  • Use of non-registered products
  • Administration of immune-modifying drugs.
  • Administration of vaccine 30 days before enrolment in study.
  • Immunosuppressive or immunodeficient condition.
  • Hypersensitivity to a previous dose of influenza vaccine
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
  • History of confirmed influenza infection within the last 12 Months.
  • Acute disease at the time of enrolment/vaccination.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine
  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: NCT00363077

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00363077     History of Changes
Other Study ID Numbers: 107975
Study First Received: August 7, 2006
Results First Received: March 21, 2013
Last Updated: May 16, 2013
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by GlaxoSmithKline:
Influenza vaccine
Prophylaxis Influenza vaccine

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 July 22, 2014