Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00971425
First received: August 27, 2009
Last updated: March 15, 2011
Last verified: February 2011

August 27, 2009
March 15, 2011
September 2009
October 2010   (final data collection date for primary outcome measure)
  • Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]

    Titers were expressed as GMTs.

    The Pandemrix vaccine strain was A/Cal/7/09.

  • Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]

    The Pandemrix vaccine strain was A/Cal/7/09.

    The cut-off was a titer of 1:10 and this titer was considered as seropositivity.

  • Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]

    The Pandemrix vaccine strain was A/Cal/7/09.

    A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

  • Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]

    Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0).

    The Pandemrix vaccine strain was A/Cal/7/09.

  • Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]

    The Pandemrix vaccine strain was A/Cal/7/09.

    A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.

Humoral immune response in terms of HI antibodies [ Time Frame: At day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00971425 on ClinicalTrials.gov Archive Site
  • Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains [ Time Frame: Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 ] [ Designated as safety issue: No ]

    Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.

    Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.

  • Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains [ Time Frame: At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 ] [ Designated as safety issue: No ]

    The cut-off was a titer of 1:10 and this titer was considered as seropositivity.

    Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.

    Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.

  • Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains [ Time Frame: At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains. ] [ Designated as safety issue: No ]

    A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

    Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.

    Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63).

  • Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains [ Time Frame: At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains. ] [ Designated as safety issue: No ]

    For the definition of seroconversion factor, please refer to the primary outcome measure.

    Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.

    Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63).

  • Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains [ Time Frame: Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 ] [ Designated as safety issue: No ]

    A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.

    Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.

    Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.

  • Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix [ Time Frame: During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix ] [ Designated as safety issue: No ]
    Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius).
  • Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix [ Time Frame: During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix ] [ Designated as safety issue: No ]
    Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius)
  • Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During 21 days (Day 0-20) after each 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.

    Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (Day 0-364) ] [ 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.
  • Number of Subjects With AEs of Specific Interest [ Time Frame: During the entire study period (Day 0-364) ] [ Designated as safety issue: No ]
    Adverse events of specific interest included auto-immune diseases and other immune mediated disorders.
  • Occurrence of solicited local signs and symptoms [ Time Frame: During a 7-Day (day 0-6) follow-up period after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of solicited general signs and symptoms [ Time Frame: During a 7-Day (day 0-6) follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During 21 days (Day 0-20) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of SAEs [ Time Frame: During the entire study period (Day 0-364) ] [ Designated as safety issue: No ]
  • Occurrence of AEs of specific interest [ Time Frame: During the entire study period (Day 0-364) ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of HI antibodies [ Time Frame: Defined time points in function of the measured parameter ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
Immunogenicity and Safety of GSK Biologicals' Pandemic Influenza Candidate Vaccine GSK2340272A

The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Influenza A Virus, H1N1 Subtype
  • Influenza Infection
  • Biological: Pandemrix (GSK investigational influenza GSK2340272A vaccine)
    2 doses intramuscular injections
  • Biological: Fluarix™
    1 dose intramuscular injection
  • Biological: Placebo
    1 dose intramuscular injection
  • Experimental: Placebo-Pandemrix-Fluarix Group
    Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
    Interventions:
    • Biological: Pandemrix (GSK investigational influenza GSK2340272A vaccine)
    • Biological: Fluarix™
    • Biological: Placebo
  • Experimental: Fluarix-Pandemrix-Placebo Group
    Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
    Interventions:
    • Biological: Pandemrix (GSK investigational influenza GSK2340272A vaccine)
    • Biological: Fluarix™
    • Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects 61 years of age or older at the time of the first vaccination.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Satisfactory baseline medical assessment by history and physical examination (stable health status with no exclusionary medical or psychiatric conditions). Stable health status is defined as the absence of health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment.

Exclusion Criteria:

  • Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere influenza vaccine.
  • Previous administration of a pandemic influenza vaccine.
  • Administration of any vaccine within 30 days before first vaccination.
  • Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with the GSK2340272A candidate vaccine.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
  • Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Presence of an axillary temperature >= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.

    • Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
    • Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excisions only are eligible and may be enrolled within 3 years of diagnosis, but other histological types of skin cancer require a 3-year untreated and disease-free window as above.
    • Women who are disease free for 3 years or more after the treatment of breast cancer and receiving long-term prophylactic tamoxifen are eligible and may be enrolled.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
  • Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination and during the entire study period.
  • Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire study period.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome.
  • Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included, as well as subjects with well controlled underlying diseases).
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • History of chronic alcohol consumption and/or drug abuse.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Both
61 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00971425
113572
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP