Trial record 2 of 33 for:    Thimerosal

Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00633074
First received: February 29, 2008
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.


Condition Intervention Phase
Influenza Infection
Biological: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)
Biological: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains [ Time Frame: Days 0 and 21 ] [ Designated as safety issue: No ]
    Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.


Secondary Outcome Measures:
  • Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains [ Time Frame: 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 three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.

  • Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains [ Time Frame: 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 three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.

  • HI Antibody Seroconversion Factors [ Time Frame: 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 three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.

  • Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains [ Time Frame: Days 0 and 21 ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a suject 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 [ Time Frame: During a 7-day period after vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.

  • Duration of Solicited Local Symptoms [ Time Frame: During a 7-day period after vaccination ] [ Designated as safety issue: No ]
    Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.

  • Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During a 7-day period after vaccination ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.

  • Duration of Solicited General Symptoms [ Time Frame: During a 7-day period after vaccination ] [ Designated as safety issue: No ]
    Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.

  • Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During a 21-day period after vaccination ] [ 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 Any, Grade 3 and Related Medically Significant Conditions (MSCs) [ Time Frame: During a 21-day period after vaccination ] [ Designated as safety issue: No ]
    Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.

  • Number of Subjects Reporting Any and Related 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: 720
Study Start Date: March 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thiomersal-free FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
Biological: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose
Experimental: Thiomersal reduced FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
Biological: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose

  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.
  • A male or female 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 (medical history and medical history directed examination) before entering into the study.

Exclusion Criteria:

  • Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 21 days after vaccination.
  • Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
  • Previous vaccination against influenza with any seasonal vaccine since July 2007.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of hypersensitivity to a previous dose of influenza vaccine.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
  • Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Any medical conditions in which IM injections are contraindicated
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633074

Locations
Estonia
GSK Investigational Site
Saku, Estonia, 75501
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tartu, Estonia, 50417
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00633074     History of Changes
Other Study ID Numbers: 111454
Study First Received: February 29, 2008
Results First Received: April 26, 2012
Last Updated: April 26, 2012
Health Authority: Estonia: The State Agency of Medicine

Keywords provided by GlaxoSmithKline:
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 April 17, 2014