Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00385840
First received: October 10, 2006
Last updated: April 25, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Influenza
Biological: Influenza Vaccine GSK1247446A
Biological: FluarixTM
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years and Above.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Any and Grade 3 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. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).

  • 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, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature > 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 normal activity. Related = Unsolicited AE assessed by the investigator as causally 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. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.


Secondary Outcome Measures:
  • Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. [ Time Frame: At Day 0 and Day 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.


Enrollment: 678
Study Start Date: October 2006
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluarix Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: FluarixTM
Single dose, intramuscular injection
Experimental: GSK1247446A Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: Influenza Vaccine GSK1247446A
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 revaccination, who previously participated in 107192 & 107214 clinical trials.
  • 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 3 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: NCT00385840

Locations
Norway
GSK Investigational Site
Elverum, Norway, 2408
GSK Investigational Site
Hamar, Norway, 2301
GSK Investigational Site
Paradis, Norway, 5231
GSK Investigational Site
Stavanger, Norway, 4010
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00385840     History of Changes
Other Study ID Numbers: 108708
Study First Received: October 10, 2006
Results First Received: March 7, 2013
Last Updated: April 25, 2013
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by GlaxoSmithKline:
Influenza vaccine
Influenza

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 August 26, 2014