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Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01001169
First received: October 22, 2009
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational influenza vaccine GSK2340274A following one dose and following a second dose, using the same dosage as has been used in the H5N1 development program in Japanese children aged 10-17 years and an alternative dose in children aged 6 months to 9 years.

Condition Intervention Phase
Influenza Biological: GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine (GSK2340274A) in Japanese Children Aged 6 Months to 17 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value [ Time Frame: At Day 42 ]

    The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10.

    The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), in subjects aged between 6 months to 9 years and 10 to 17 years, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.


  • Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 42 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

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

    Seroconversion (SCR) was defined as follows:

    For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

    The CBER criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%.

    The CHMP criterion was fulfilled if the point estimate for SCR was > 40%.


  • 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 equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

    The CBER Criterion was fulfilled if the lower 97.5% confidence interval for seroprotection (SPR) was > 70%.

    The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.


  • 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 GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.

    The CHMP Criterion was fulfilled if the point estimate for GMFR was > 2.5.



Secondary Outcome Measures:
  • Number of Subjects With HI Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0 and 21 ]
    The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • Number of Subjects With HI Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0 and 42 ]

    The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.

    Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.


  • Number of Subjects With HI Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0 and 182 ]
    The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Days 0 and 21 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Days 0 and 42 ]

    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.

    Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.


  • Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Days 0 and 182 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

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

    Seroconversion (SCR) was defined as follows:

    For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

    The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%.


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

    Seroconversion (SCR) was defined as follows:

    For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.

    The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%.

    Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.


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

    Seroconversion (SCR) was defined as follows:

    For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

    The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%.


  • 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 equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

    The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.

    The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%.


  • Number of Seroprotected Subjects for HI Antibodies [ Time Frame: At Days 0 and 42 ]

    A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.

    The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.

    The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%.

    Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.


  • Number of Seroprotected Subjects for HI Antibodies [ Time Frame: At Days 0 and 182 ]

    A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

    The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.

    The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%.


  • 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 GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.

    The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5.


  • SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 42 ]

    SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP guidance.

    The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.


  • SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [ Time Frame: At Day 182 ]

    SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.

    The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5.


  • Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0 and 21 ]
    The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0 and 42 ]
    The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0 and 182 ]
    The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease [ Time Frame: At Days 0 and 21 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease [ Time Frame: At Days 0 and 42 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease [ Time Frame: At Days 0 and 182 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1 [ Time Frame: At Day 21 ]
    VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1 [ Time Frame: At Day 42 ]
    VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1 [ Time Frame: At Day 182 ]
    VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  • 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 [child below (<) 6 years] = cried when limb was moved/spontaneously painful. Grade 3 pain [child equal to or above (≥) 6 years] = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

  • 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 drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever ≥ 39.0 °C - ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination.

  • 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, gastrointestinal, 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 any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C - ≤ 40.0°C. Related symptom = symptom assessed by the investigator as causally related to the study vaccination.

  • Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Up to 84 days (Days 0-83) after the first vaccination ]
    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.

  • Number of Subjects With Medically Attended Events (MAEs) [ Time Frame: During the entire study period (from Day 0 to Day 182) ]
    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.

  • Number of Subjects With Potential Immune-Mediated Diseases (pIMDs) [ Time Frame: During the entire study period (from Day 0 to Day 182) ]
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to Day 182) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of Subjects With Normal or Abnormal Biochemical Levels [ Time Frame: At Days 0, 7 and 42 ]

    Among biochemical parameters assessed were Alanine Amino Transferase (ALAT), Albumin, Alkaline Phosphatase (AP), Aspartate Amino Transferase (ASAT), Bilirubin, Bilirubin Conjugated/Direct, Cholesterol, Chloride, Creatinine, Creatine Phosphokinase (CK), Gamma-Glutamyl Transpeptidase (GGT), Potassium, Lactate dehydrogenase (LDH), Sodium, Protein, Urate/Uric acid and Blood Urea Nitrogen (BUN).

    Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.


  • Number of Subjects With Normal or Abnormal Values of Haematological Parameters [ Time Frame: At Days 0, 7 and 42 ]

    Among haematological parameters assessed were Basophils (Baso), Eosinophils (EOS), Hematocrit (HEM), Hemoglobin (Hgb), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLA), Red Blood Cells (RBC) and White Blood Cells (WBC).

    Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.



Enrollment: 60
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK2340274A_F1 6M-9Y GROUP
Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
Biological: GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)
Two intramuscular injections
Experimental: GSK2340274A_F2 10Y-17Y GROUP
Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Biological: GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)
Two intramuscular injections

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • Japanese children, male or female, aged between 6 months and 17 years at the time of the first study vaccination.
  • Written informed consent obtained from the subject's parent(s) or LAR(s) of the subject. Whenever possible, an assent should also be obtained from the subject.
  • Healthy children as established by medical history and clinical examination when entering into the study (Particular attention must be exercised when dealing with patients with bronchial asthma).
  • Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
  • 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 (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • Clinically or virologically confirmed influenza infection from May 2009 to the day of enrolment.
  • Previous administration of a novel [H1N1]v vaccine.
  • Administration of any vaccines within 30 days before vaccination or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182, with the exception of seasonal influenza vaccine.
  • Administration of any seasonal influenza vaccine within 14 days before vaccination on Day 0, or planned administration within the first vaccination up to blood sampling at Day 42 and within 14 days prior to blood sampling at Day 182.
  • Excessive underweight or excessive obesity. (Under or upper 2-fold standard deviation of weight distribution that are corresponding age group are used as reference).
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
  • Acute disease and/or fever at the time of enrolment:
  • Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal 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 confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • History of any neurological disorder including acute disseminated encephalomyelitis and Guillain-Barré syndrome, or convulsive seizures and epilepsy.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible
  • Any conditions which, in the opinion of the investigator, prevents the subject from participating to the study.
  • Child in Care.
  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: NCT01001169

Locations
Japan
GSK Investigational Site
Tokyo, Japan, 157-8535
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113847
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: 113847
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: 113847
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113847
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: 113847
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: 113847
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: 113847
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: NCT01001169     History of Changes
Other Study ID Numbers: 113847
Study First Received: October 22, 2009
Results First Received: March 14, 2017
Last Updated: March 22, 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 GSK2340274A
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

ClinicalTrials.gov processed this record on July 26, 2017