Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00938392
First received: July 9, 2009
Last updated: June 7, 2012
Last verified: April 2012
  Purpose

The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A.


Condition Intervention Phase
Influenza Infection
Biological: GSK investigational FluNG vaccine GSK2186877A, aged lot
Biological: GSK investigational FluNG vaccine GSK2186877A, fresh lot
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity & Safety Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Adults.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
    Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.


Secondary Outcome Measures:
  • Number of Subjects Seropositive Against the 3 Vaccine Strains [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
    A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.

  • Number of Subjects Seroconverted for the 3 Vaccine Strains [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.

  • Seroconversion Factor for the 3 Vaccine Strains [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.

  • Number of Subjects Seroprotected for the 3 Vaccine Strains [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.

  • Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day post-vaccination period ] [ Designated as safety issue: No ]
    Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever [oral temperature greater than or equal to 38 degrees Celsius (°C)]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination.

  • Duration of Solicited Local and General Symptoms [ Time Frame: During the 7-day post-vaccination period ] [ Designated as safety issue: No ]
    Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced.

  • Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During the 21-day 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.

  • Number of Subjects Reporting Adverse Events of Specific Interest (AESI) [ Time Frame: During the 21-day post-vaccination period ] [ Designated as safety issue: No ]
    AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (up to Day 21) ] [ 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.


Enrollment: 726
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FluNG Aged Group
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
Biological: GSK investigational FluNG vaccine GSK2186877A, aged lot
Single dose, intramuscular injection
Experimental: FluNG Fresh Group
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
Biological: GSK investigational FluNG vaccine GSK2186877A, fresh lot
Single dose, intramuscular injection

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
  • A man or woman 65 years of age or older at the time of vaccination.
  • Written informed consent obtained from the subject.
  • Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.

Exclusion Criteria:

  • Any confirmed or suspected influenza illness within the last 6 months.
  • Previous vaccination against influenza with any seasonal vaccine since December 2008.
  • Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use 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 Visit 2.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein, included history of hypersensitivity to a previous dose of influenza vaccine.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature >= 37.5°C on oral setting.
    • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
  • Any medical conditions in which intramuscular injections are contraindicated.
  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: NCT00938392

Locations
Estonia
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tartu, Estonia, 50106
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 814 66
GSK Investigational Site
Bratislava, Slovakia, 811 03
GSK Investigational Site
Bratislava, Slovakia, 841 04
GSK Investigational Site
Velky Biel, Slovakia, 900 24
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00938392     History of Changes
Other Study ID Numbers: 112662
Study First Received: July 9, 2009
Results First Received: April 19, 2012
Last Updated: June 7, 2012
Health Authority: Slovakia: State Institute for Drug Control
Estonia: State Agency of Medicines

Keywords provided by GlaxoSmithKline:
influenza infection
GSK Bio's influenza vaccine GSK2186877A

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

ClinicalTrials.gov processed this record on October 20, 2014