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Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults

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ClinicalTrials.gov Identifier: NCT00968539
Recruitment Status : Completed
First Posted : August 31, 2009
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Influenza Biological: GSK investigational vaccine GSK2340272A Biological: GSK investigational vaccine GSK2340269A Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2340272A in Adults Aged 18 to 60 Years
Study Start Date : September 1, 2009
Actual Primary Completion Date : September 28, 2010
Actual Study Completion Date : September 28, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: GSK2340272A GROUP
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Biological: GSK investigational vaccine GSK2340272A
Two intramuscular injections

Experimental: GSK2340269A GROUP
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Biological: GSK investigational vaccine GSK2340269A
Two intramuscular injections




Primary Outcome Measures :
  1. Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies [ Time Frame: At Day 42 ]

    Seroconversion was defined as:

    For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.

    The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).


  2. Number of Seroprotected Subjects for HI Antibodies [ Time Frame: At Day 42 ]
    A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

  3. Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 42 ]

    GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.

    The flu strain assessed was Flu A/CAL/7/09.



Secondary Outcome Measures :
  1. Number of Subjects With HI Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0, 21 and 42 ]

    Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.

    The Flu strain assessed was Flu A/CAL/7/09.


  2. Number of Subjects With HI Antibody Concentrations Above the Cut-off Value [ Time Frame: At Day 182 ]

    Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.

    The Flu strain assessed was Flu A/CAL/7/09.


  3. Number of Subjects With HI Antibody Concentrations Above the Cut-off Value [ Time Frame: At Day 364 ]

    Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.

    The Flu strain assessed was Flu A/CAL/09.


  4. Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Days 0, 21 and 42 ]
    Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

  5. Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 182 ]
    Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

  6. Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 364 ]
    Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

  7. Number of Seroconverted Subjects for HI Antibodies [ Time Frame: At Day 21 ]

    Seroconversion was defined as:

    For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.

    The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).


  8. Number of Seroconverted Subjects for HI Antibodies [ Time Frame: At Day 42 ]

    Seroconversion was defined as:

    For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.

    The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).


  9. Number of Seroconverted Subjects for HI Antibodies [ Time Frame: At Day 182 ]

    Seroconversion was defined as:

    For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.

    The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).


  10. Number of Seroconverted Subjects for HI Antibodies [ Time Frame: At Day 364 ]

    Seroconversion was defined as:

    For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.

    The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).


  11. Number of Seroprotected Subjects for HI Antibodies [ Time Frame: At Days 0 and 21 ]
    A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

  12. Number of Seroprotected Subjects for HI Antibodies [ Time Frame: At Day 42 ]
    A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

  13. Number of Seroprotected Subjects for HI Antibodies [ Time Frame: At Day 182 ]
    A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

  14. Number of Seroprotected Subjects for HI Antibodies [ Time Frame: At Day 364 ]
    A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

  15. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 21 ]

    Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.

    The flu strain assessed was Flu A/CAL/7/09.


  16. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 42 ]

    Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.

    The flu strain assessed was Flu A/CAL/7/09.


  17. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 182 ]

    Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.

    The flu strain assessed was Flu A/CAL/7/09.


  18. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 364 ]

    Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.

    The flu strain assessed was Flu A/CAL/7/09.


  19. Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease [ Time Frame: At Days 0, 21 and 42 ]
    Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8.

  20. Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 [ Time Frame: At Days 21 and 42 ]

    Seroconversion was defined as:

    For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Neth/602/09.


  21. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

  22. Number of Days With Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    The number of days with any solicited local symptoms reported during the solicited post-vaccination period. There were no subjects from GSK2340269A Group who reported Redness or Swelling.

  23. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever [defined as axillary temperature equal to or above ≥ 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  24. Number of Days With Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    The number of days with any solicited general symptoms reported during the solicited post-vaccination period. There were no subjects from GSK2340269A Group who reported Temperature.

  25. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 83) ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  26. Number of Subjects With Adverse Events of Specific Interest (AESIs) [ Time Frame: During the entire study period (from Day 0 up to Day 364) ]
    An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

  27. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 up to Day 364) ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female aged 18 to 60 years 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 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 enrollment.
  • Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine 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 the past 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 excepted and may enroll 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 3 years or more after the treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
  • Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
  • Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the 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.
  • Administration of any vaccines within 30 days before vaccination.
  • 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.
  • Pregnant or lactating female
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968539


Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113456
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 113456
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 113456
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 113456
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113456
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113456
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 113456
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00968539     History of Changes
Other Study ID Numbers: 113456
First Posted: August 31, 2009    Key Record Dates
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
GSK Bio's influenza vaccine GSK2340272A
influenza infection

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs