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
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 April 17, 2014