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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00968526
Recruitment Status : Completed
First Posted : August 31, 2009
Results First Posted : September 18, 2018
Last Update Posted : June 25, 2019
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 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2340272A in Adults Aged 18 Years and Above
Actual Study Start Date : September 8, 2009
Actual Primary Completion Date : September 23, 2010
Actual Study Completion Date : September 23, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: GSK2340272A 2D Group
Healthy male or female adults, aged 18 to 60 years (18-60y) and above (>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Biological: GSK investigational vaccine GSK2340272A
One or two intramuscular injections in the deltoid region of the non-dominant or the dominant arm.

Experimental: GSK2340272A 1D Group
Healthy male or female adults, aged 18 to 60 years (18-60y) and above (>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Biological: GSK investigational vaccine GSK2340272A
One or two intramuscular injections in the deltoid region of the non-dominant or the dominant arm.




Primary Outcome Measures :
  1. Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies [ Time Frame: At Day 21 ]
    Seroconversion was defined as: For initially seronegative subjects [antibody titer (below) < 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 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). This outcome included only subjects who received two doses of the study product and results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age .

  2. Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain [ Time Frame: At Day 21 ]
    A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age .

  3. Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 21 ]
    GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. This outcome included only subjects who received two doses of the study product and results were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was > 2.5 in subjects 18 to 60 years old or > 2 for subjects > 60 years of age.


Secondary Outcome Measures :
  1. Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain [ Time Frame: At Days 0, 21 and 42 ]
    A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. The results for this assay were tabulated per age stratum.

  2. Titers for Serum Hemagglutination Inhibition (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. The results for this assay were tabulated per age stratum.

  3. Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain [ Time Frame: At Day 182 and 364 ]
    A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. The results for this assay were tabulated per age stratum.

  4. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 182 and 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. The results for this assay were tabulated per age stratum.

  5. Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease [ Time Frame: At Days 21 and 42 ]
    Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post to vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 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). This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age .

  6. Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Days 182 and 364 ]
    Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post to vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 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). The results for this assay were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age .

  7. Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain [ Time Frame: At Days 0, 21 and 42 ]
    A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age .

  8. Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain [ Time Frame: At Days 182 and 364 ]
    A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The results for this assay were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

  9. Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Days 21 and 42 ]
    GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was > 2.5 in subjects 18 to 60 years old or > 2 for subjects > 60 years of age.

  10. Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 182 and 364 ]
    GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The results for this assay were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was > 2.5 in subjects 18 to 60 years old or > 2 for subjects > 60 years of age.

  11. Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 [ Time Frame: At Days 0, 21, 42 and 182 ]
    A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:8, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/Neth/602/09. The results for this assay were tabulated per age stratum.

  12. Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease [ Time Frame: At Days 0, 21, 42 and 182 ]
    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. The results for this assay were tabulated per age stratum.

  13. Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 [ Time Frame: At Days 21, 42 and 182 ]
    Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:8 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. The results were tabulated per age stratum.

  14. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-dose 1 vaccination period ]
    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. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.

  15. Number of Days With Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-dose 1 vaccination period ]
    The number of days with any solicited local symptoms reported during the solicited post-vaccination period. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.

  16. 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. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum.

  17. 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. This outcome included only subjects who received 2 doses of the study product and the results were tabulated per age stratum. No subjects from GSK2340272A 2D (18-60y) Sub-Group presented any redness post dose 1.

  18. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-dose 1 vaccination period ]
    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. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.

  19. Number of Days With Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-dose 1 vaccination period ]
    The number of days with any solicited general symptoms reported during the solicited post-vaccination period. This outcome included all the subjects who received 1 dose of the study product and the results were tabulated per age stratum.

  20. 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 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. This outcome inlcuded only subjects who received two doses of the study product and the results were tabulated per age stratum.

  21. 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. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum. No subjects from GSK2340272A 2D (>60y) Sub-Group reported any temperature.

  22. 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. The results were tabulated per age stratum.

  23. Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels [ Time Frame: At Days 0, 21, 42, 182 and 364 ]
    Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], total bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above in subjects aged 18-60 years and > 60 years old.

  24. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Within 21 days after the first vaccination (Day 0 - Day 20) ]
    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. This outcome included all the subjects who received 1 dose of the study product and the results were tabulated per age stratum.

  25. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Within 84 days after the first vaccination and 63 days after the second vaccination (Day 0 - 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. The results were tabulated per age stratum.

  26. 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. The results were tabulated per age stratum.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female aged 18 years or above 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 a 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.
  • 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 other multiple-user device.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • 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 >= 37.5ºC, 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 excision only are excepted and may enrol 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 treatment for breast cancer and receiving long-term prophylactic hormonal therapy are excepted and may enrol.
  • 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 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.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
  • Administration of any vaccines within 30 days before vaccination.
  • Any known or suspected allergy to any constituent of influenza vaccines; 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): NCT00968526


Locations
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Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 113459
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: 113459
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113459
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113459
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: 113459
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: 113459
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113459
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00968526     History of Changes
Other Study ID Numbers: 113459
2009-013837-92 ( EudraCT Number )
First Posted: August 31, 2009    Key Record Dates
Results First Posted: September 18, 2018
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com
Keywords provided by GlaxoSmithKline:
influenza infection
GSK Bio's influenza vaccine GSK2340272A
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs