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Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00391053
Collaborator
(none)
3,851
Enrollment
28
Locations
4
Arms
16
Duration (Months)
137.5
Patients Per Site
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at higher risk for influenza-related morbidity and mortality, represents an important unmet need.

Primary Objectives:
Immunogenicity:

  • To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing process through evaluation of the immune responses elicited by three different lots.

  • To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone® vaccine.

Secondary Objectives:
Immunogenicity:
  • To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone® vaccine.
Safety:

  • To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited adverse and serious adverse events post-vaccination.

  • To describe clinical information on some additional defined criteria during the six months following vaccination.

Condition or Disease Intervention/Treatment Phase
  • Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
  • Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
  • Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
  • Biological: Inactivated, Split-Virion Influenza Vaccine
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
3851 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Phase III Lot Consistency, Immunogenicity and Safety Study of Three Lots of Fluzone High Dose Vaccine Compared With One Lot of Standard Fluzone® in Adults ≥ 65 Years of Age.
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Feb 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Group 1

Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1

Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
0.5 mL, IM
Other Names:
  • Fluzone® High-Dose

    		•
    Experimental: Study Group 2

    Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2

    Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
    0.5 mL, IM
    Other Names:
  • Fluzone® High-Dose

    		•
    Experimental: Study Group 3

    Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3

    Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
    0.5 mL, IM
    Other Names:
  • Fluzone® High-Dose

    		•
    Active Comparator: Group 4

    Participants will receive the Standard Fluzone® vaccine

    Biological: Inactivated, Split-Virion Influenza Vaccine
    0.5 mL, IM
    Other Names:
  • Fluzone® 2006-2007 formulation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines. [Day 0 and Day 28 Post-vaccination]

      Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.

    2. Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines. [Day 28 Post-vaccination]

      Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer <10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).

    Secondary Outcome Measures

    1. Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines. [Day 0 and Day 28 Post-vaccination]

      Seroprotection was defined as a Hemagglutination Inhibition Titers of at least 40 (≥ 1:40) for each of the Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) pre- or post-vaccination with Fluzone® High-Dose or Standard Fluzone® vaccines.

    2. Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination [Day 0 to Day 7 Post-vaccination]

      The occurrence, time to onset, number of days of occurrence, and severity of solicited injection site reactions: Injection Site Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia were collected.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Aged ≥ 65 years on the day of vaccination.

    • Informed consent form signed.

    • Medically stable. (Subjects may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled. If they are on medication for a condition, the medication dose must have been stable for at least 3 weeks preceding vaccination.)

    • Able to attend all scheduled visits and to comply with all trial procedures.

    Exclusion Criteria:

    • Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Fluzone® vaccine or a vaccine containing any of the same substances.

    • Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months.

    • Systemic corticosteroid therapy, as follows:

    Continuous use with a dosage equivalent to > 15 mg/day of oral prednisone for 90 days preceding vaccination.

    Sporadic use with a dosage equivalent to > 40 mg/day of oral prednisone for > 14 consecutive days in the 90 days preceding vaccination.

    Note:Use of topical or inhalant corticosteroids is acceptable.

    • Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease-free for ≥ 5 years).

    • Current alcohol abuse or drug addiction that in the opinion of the investigator may interfere with the subject's ability to comply with trial procedures.

    • Receipt of blood or blood-derived products in the past three months.

    • Participation in a trial of a high-dose influenza vaccine in the past 12 months.

    • Receipt of influenza vaccine in the past six months.

    • Receipt of any other vaccine in the past four weeks.

    • Planned receipt of any other vaccine in the four weeks following the trial vaccination.

    • Participation in another clinical trial in the past four weeks.

    • Planned participation in another clinical trial during the present trial period.

    Note:Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.

    • Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.

    • History of Guillain-Barré syndrome.

    • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

    • An acute febrile illness (oral temperature ≥ 99.5ºF [≥ 37.5ºC]) within 24 hours prior to vaccination. If this contraindication exists, vaccination will be deferred until the participant has been afebrile for at least 24 hours.

    • Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mesa Arizona United States
    2 Phoenix Arizona United States
    3 Tempe Arizona United States
    4 Tucson Arizona United States
    5 San Diego California United States
    6 Stratford Connecticut United States
    7 Clearwater Florida United States
    8 Coral Gables Florida United States
    9 Orlando Florida United States
    10 Pembroke Pines Florida United States
    11 Wichita Kansas United States
    12 Rockville Maryland United States
    13 Rochester Minnesota United States
    14 Kansas City Missouri United States
    15 St. Louis Missouri United States
    16 Endwell New York United States
    17 Rochester New York United States
    18 Cary North Carolina United States
    19 Raleigh North Carolina United States
    20 Downington Pennsylvania United States
    21 Erie Pennsylvania United States
    22 Warwick Rhode Island United States
    23 Dallas Texas United States
    24 Plano Texas United States
    25 West Jordan Utah United States
    26 Norfolk Virginia United States
    27 Richmond Virginia United States
    28 Marshfield Wisconsin United States

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00391053
    Other Study ID Numbers:
    • FIM05
    First Posted:
    Oct 23, 2006
    Last Update Posted:
    Apr 14, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Sanofi Pasteur, a Sanofi Company
    Influenza
    Orthomyxoviruses
    Inactivated Split-virion influenza vaccine
    Adults
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Influenza, Human
    Orthomyxoviridae Infections
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled from 09 October 2006 to 21 December 2006 at 30 US sites.
    Pre-assignment Detail A total of 3851 participants who met the inclusion and exclusion criteria were randomized and vaccinated. The vaccine received by 14 participants could not be verified, they were excluded from all analyses except immunogenicity analysis. 4 participants that started the study, but had no post-vaccination assessment were also excluded from analysis.
    Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®)
    Arm/Group Description Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3 Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
    Period Title: Overall Study
    STARTED 857 848 870 1262
    COMPLETED 848 847 868 1252
    NOT COMPLETED 9 1 2 10

    Baseline Characteristics

    Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®) Total
    Arm/Group Description Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3 Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation Total of all reporting groups
    Overall Participants 855 848 870 1260 3833
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    855
    100%
    848
    100%
    870
    100%
    1260
    100%
    3833
    100%
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    72.9
    (6.15)
    72.9
    (6.20)
    72.9
    (6.17)
    72.9
    (5.99)
    72.9
    (6.17)
    Sex: Female, Male (Count of Participants)
    Female
    437
    51.1%
    438
    51.7%
    445
    51.1%
    688
    54.6%
    2008
    52.4%
    Male
    418
    48.9%
    410
    48.3%
    425
    48.9%
    572
    45.4%
    1825
    47.6%
    Region of Enrollment (participants) [Number]
    United States
    855
    100%
    848
    100%
    870
    100%
    1260
    100%
    3833
    100%

    Outcome Measures

    1. Primary Outcome
    Title Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.
    Description Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.
    Time Frame Day 0 and Day 28 Post-vaccination

    Outcome Measure Data

    Analysis Population Description
    The geometric mean titers was assessed in the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.
    Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®)
    Arm/Group Description Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3 Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
    Measure Participants 854 861 861 1275
    A/H1N1 New Caledonia Pre-Dose
    28.25
    29.41
    27.86
    29.36
    A/H1N1 New Caledonia Post-Dose
    112.77
    114.63
    120.02
    67.29
    A/H3N2 Wisconsin Pre-Dose
    74.53
    77.3
    72.07
    74.74
    A/H3N2 Wisconsin Post-Dose
    595.03
    628.54
    603.59
    332.46
    B/Malaysia Pre-Dose
    19.24
    18.96
    19.78
    18.96
    B/Malaysia Post-Dose
    68.98
    69.26
    68.93
    52.34
    2. Primary Outcome
    Title Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
    Description Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer <10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).
    Time Frame Day 28 Post-vaccination

    Outcome Measure Data

    Analysis Population Description
    The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.
    Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®)
    Arm/Group Description Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3 Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
    Measure Participants 854 861 861 1275
    A/H1N1 New Caledonia
    47
    5.5%
    47
    5.5%
    52
    6%
    23
    1.8%
    A/H3N2 Wisconsin
    70
    8.2%
    68
    8%
    70
    8%
    51
    4%
    B/Malaysia
    43
    5%
    41
    4.8%
    42
    4.8%
    30
    2.4%
    3. Secondary Outcome
    Title Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
    Description Seroprotection was defined as a Hemagglutination Inhibition Titers of at least 40 (≥ 1:40) for each of the Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) pre- or post-vaccination with Fluzone® High-Dose or Standard Fluzone® vaccines.
    Time Frame Day 0 and Day 28 Post-vaccination

    Outcome Measure Data

    Analysis Population Description
    The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.
    Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®)
    Arm/Group Description Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3 Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
    Measure Participants 854 861 861 1275
    A/H1N1 New Caledonia Pre-Dose
    44
    5.1%
    46
    5.4%
    42
    4.8%
    46
    3.7%
    A/H1N1 New Caledonia Post-Dose
    91
    10.6%
    89
    10.5%
    90
    10.3%
    77
    6.1%
    A/H3N2 Wisconsin Pre-Dose
    70
    8.2%
    69
    8.1%
    68
    7.8%
    69
    5.5%
    A/H3N2 Wisconsin Post-Dose
    99
    11.6%
    99
    11.7%
    99
    11.4%
    97
    7.7%
    B/Malaysia Pre-Dose
    27
    3.2%
    28
    3.3%
    30
    3.4%
    27
    2.1%
    B/Malaysia Post-Dose
    80
    9.4%
    78
    9.2%
    80
    9.2%
    68
    5.4%
    4. Secondary Outcome
    Title Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination
    Description The occurrence, time to onset, number of days of occurrence, and severity of solicited injection site reactions: Injection Site Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia were collected.
    Time Frame Day 0 to Day 7 Post-vaccination

    Outcome Measure Data

    Analysis Population Description
    The safety analysis was performed on the Full Analysis Set according to the participants who actually received a vaccine, whether or not the subject received the assigned vaccine. A total of 3,833 participants were included in the analysis set for the evaluation of all safety.
    Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Active Comparator (Standard Fluzone®)
    Arm/Group Description Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3 Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
    Measure Participants 855 848 870 1260
    Any Solicited Injection Site Reaction
    41
    4.8%
    42
    5%
    43
    4.9%
    31
    2.5%
    Any Swelling
    9
    1.1%
    9
    1.1%
    9
    1%
    6
    0.5%
    Grade 3 Swelling (≥ 5 cm)
    1
    0.1%
    2
    0.2%
    1
    0.1%
    1
    0.1%
    Any Erythema
    16
    1.9%
    15
    1.8%
    14
    1.6%
    11
    0.9%
    Grade 3 Erythema (≥ 5 cm)
    3
    0.4%
    1
    0.1%
    2
    0.2%
    1
    0.1%
    Any Pain
    35
    4.1%
    34
    4%
    38
    4.4%
    24
    1.9%
    Grade 3 Pain (Incapacitating)
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    Any Solicited Systemic Reaction
    37
    4.3%
    33
    3.9%
    33
    3.8%
    29
    2.3%
    Any Fever
    4
    0.5%
    3
    0.4%
    4
    0.5%
    2
    0.2%
    Grade 3 Fever (>102.2 ºF or >39.0 ºC)
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Any Headache
    17
    2%
    16
    1.9%
    17
    2%
    14
    1.1%
    Grade 3 Headache (Prevents Daily Activities)
    1
    0.1%
    2
    0.2%
    1
    0.1%
    0
    0%
    Any Malaise
    20
    2.3%
    18
    2.1%
    16
    1.8%
    14
    1.1%
    Grade 3 Malaise (Prevents Daily Activities)
    1
    0.1%
    2
    0.2%
    2
    0.2%
    1
    0.1%
    Any Myalgia
    23
    2.7%
    21
    2.5%
    21
    2.4%
    18
    1.4%
    Grade 3 Myalgia (Prevents Daily Activities)
    1
    0.1%
    1
    0.1%
    2
    0.2%
    0
    0%

    Adverse Events

    Time Frame Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination
    Adverse Event Reporting Description
    Arm/Group Title High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Standad Dose Inactivated, Split-Virion Influenza Vaccine
    Arm/Group Description
    All Cause Mortality
    High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Standad Dose Inactivated, Split-Virion Influenza Vaccine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Standad Dose Inactivated, Split-Virion Influenza Vaccine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 56/855 (6.5%) 56/848 (6.6%) 44/870 (5.1%) 93/1260 (7.4%)
    Blood and lymphatic system disorders
    Anaemia 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Pancytopenia 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Cardiac disorders
    Acute coronary syndrome 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Acute myocardial infarction 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Angina pectoris 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Angina unstable 0/855 (0%) 0 2/848 (0.2%) 2 0/870 (0%) 0 1/1260 (0.1%) 1
    Atrial fibrillation 0/855 (0%) 0 2/848 (0.2%) 2 1/870 (0.1%) 1 3/1260 (0.2%) 3
    Cardiac arrest 0/855 (0%) 0 1/848 (0.1%) 1 1/870 (0.1%) 1 2/1260 (0.2%) 2
    Cardiac Failure 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Cardiac failure congestive 4/855 (0.5%) 5 3/848 (0.4%) 3 0/870 (0%) 0 2/1260 (0.2%) 2
    Cardio-respiratory arrest 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Congestive cardiomyopathy 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Coronary artery disease 2/855 (0.2%) 2 3/848 (0.4%) 3 0/870 (0%) 0 4/1260 (0.3%) 4
    Coronary artery occlusion 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 1/1260 (0.1%) 1
    Myocardial infarction 2/855 (0.2%) 2 1/848 (0.1%) 1 2/870 (0.2%) 2 4/1260 (0.3%) 4
    Ventricular fibrillation 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Congenital, familial and genetic disorders
    Atrial septal defect 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Gastrointestinal disorders
    Abdominal mass 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Abdominal pain 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 1/1260 (0.1%) 1
    Constipation 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Crohn's disease 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Duodenitis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Enterovesical fistula 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Gastritis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Gastrointestinal haemorrhage 0/855 (0%) 0 1/848 (0.1%) 1 1/870 (0.1%) 1 0/1260 (0%) 0
    Oesophagitis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 2/1260 (0.2%) 2
    Small intestinal obstruction 0/855 (0%) 0 1/848 (0.1%) 1 3/870 (0.3%) 3 1/1260 (0.1%) 1
    Small intestinal perforation 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Umbilical hernia 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Upper gastrointestinal haemorrhage 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    General disorders
    Asthenia 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Chest pain 0/855 (0%) 0 2/848 (0.2%) 2 0/870 (0%) 0 5/1260 (0.4%) 5
    Fatigue 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Hernia 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Malaise 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Non-cardiac chest pain 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 2/1260 (0.2%) 2
    Hepatobiliary disorders
    Cholecystitis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 2/1260 (0.2%) 2
    Cholecystitis acute 2/855 (0.2%) 2 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Cholelithiasis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Chronic hepatic failure 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Infections and infestations
    Bronchitis 2/855 (0.2%) 2 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Cellulitis of male external genital organ 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Clostridium difficile colitis 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 1/1260 (0.1%) 1
    Diverticulitis 0/855 (0%) 0 2/848 (0.2%) 2 1/870 (0.1%) 1 2/1260 (0.2%) 2
    Extradural abscess 1/855 (0.1%) 1 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Gastroenteritis 0/855 (0%) 0 3/848 (0.4%) 3 1/870 (0.1%) 1 0/1260 (0%) 0
    Gastroenteritis viral 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Implant site cellulitis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Lung infection 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Osteomyelitis 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Pneumonia 6/855 (0.7%) 6 5/848 (0.6%) 6 6/870 (0.7%) 8 4/1260 (0.3%) 4
    Sepsis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 2/1260 (0.2%) 2
    Staphylococcal infection 1/855 (0.1%) 1 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Urinary tract infection 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Back injury 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Injury, poisoning and procedural complications
    Acetabulum fracture 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Ankle fracture 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Clavicle fracture 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Compression fracture 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Concussion 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Contusion 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Device failure 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Fall 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Femoral neck fracture 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 2/1260 (0.2%) 2
    Femur fracture 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Head Injury 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Hip fracture 0/855 (0%) 0 0/848 (0%) 0 2/870 (0.2%) 2 0/1260 (0%) 0
    Humerus fracture 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Joint injury 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Pacemaker complication 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Patella fracture 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Perirenal haematoma 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Post procedural haemorrhage 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 1/1260 (0.1%) 1
    Postoperative ileus 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Spinal compression fracture 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Subdural haematoma 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Thoracic vertebral fracture 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Tibia fracture 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Upper limb fracture 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 2/1260 (0.2%) 2
    Investigations
    Helicobacter pylori identification test positive 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Diabetes mellitus inadequate control 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Diabetic ketoacidosis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Gout 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Arthritis 2/855 (0.2%) 2 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Back pain 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Intervertebral disc protrusion 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 2/1260 (0.2%) 2
    Lumbar spinal stenosis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Monarthritis 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Musculoskeletal pain 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Osteoarthritis 1/855 (0.1%) 1 1/848 (0.1%) 1 0/870 (0%) 0 1/1260 (0.1%) 1
    Spinal column stenosis 1/855 (0.1%) 1 0/848 (0%) 0 1/870 (0.1%) 1 1/1260 (0.1%) 2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Brain neoplasm malignant 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 1/1260 (0.1%) 1
    Breast cancer 0/855 (0%) 0 2/848 (0.2%) 2 2/870 (0.2%) 2 1/1260 (0.1%) 1
    Breast cancer metastatic 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Bronchioloalveolar carcinoma 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Cervix carcinoma 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Colon adenoma 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Colon cancer 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Hepatic neoplasm malignant 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Laryngeal cancer 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Lung adenocarcinoma 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Lung neoplasm malignant 0/855 (0%) 0 1/848 (0.1%) 1 1/870 (0.1%) 1 1/1260 (0.1%) 1
    Non-hodgkin's lymphoma 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Non-small cell lung cancer 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Prostate cancer 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 2/1260 (0.2%) 2
    Renal cell carcinoma stage unspecified 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Sinus cancer metastatic 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Uterine cancer 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Nervous system disorders
    Oesophageal carcinoma 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Carotid artery stenosis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Cerebrovascular accident 0/855 (0%) 0 5/848 (0.6%) 5 0/870 (0%) 0 1/1260 (0.1%) 1
    Coordination abnormal 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Dizziness 1/855 (0.1%) 1 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Facial palsy 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Grand mal convulsion 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Guillain-barre syndrome 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Headache 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 1/1260 (0.1%) 1
    Hypoaesthesia 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Myasthenia gravis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Normal pressure hydrocephalus 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Parkinson's disease 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Syncope 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 5/1260 (0.4%) 5
    Syncope vasovagal 2/855 (0.2%) 2 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Transient ischaemic attack 1/855 (0.1%) 1 1/848 (0.1%) 1 3/870 (0.3%) 4 4/1260 (0.3%) 4
    Psychiatric disorders
    Affective disorder 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Anxiety 2/855 (0.2%) 2 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Bipolar I disorder 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Bipolar disorder 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Drug dependence 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Mental status changes 3/855 (0.4%) 3 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Renal and urinary disorders
    Renal failure acute 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 2/1260 (0.2%) 2
    Renal failure chronic 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Urinary incontinence 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Urinary retention 1/855 (0.1%) 1 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Cystocele 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Rectocele 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Bronchospasm 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Chronic obstructive pulmonary disease 1/855 (0.1%) 1 2/848 (0.2%) 2 0/870 (0%) 0 3/1260 (0.2%) 3
    Dyspnoea 2/855 (0.2%) 2 2/848 (0.2%) 2 0/870 (0%) 0 0/1260 (0%) 0
    Epistaxis 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 2/1260 (0.2%) 3
    Pleural effusion 0/855 (0%) 0 3/848 (0.4%) 4 0/870 (0%) 0 2/1260 (0.2%) 2
    Pneumonia aspiration 0/855 (0%) 0 1/848 (0.1%) 2 0/870 (0%) 0 0/1260 (0%) 0
    Pneumonitis 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Pneumothorax 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 0/1260 (0%) 0
    Pulmonary embolism 2/855 (0.2%) 2 2/848 (0.2%) 2 3/870 (0.3%) 3 1/1260 (0.1%) 1
    Skin and subcutaneous tissue disorders
    Erythema 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Urticaria 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 1/1260 (0.1%) 1
    Vascular disorders
    Aortic aneurysm 0/855 (0%) 0 0/848 (0%) 0 1/870 (0.1%) 1 2/1260 (0.2%) 2
    Deep vein thrombosis 1/855 (0.1%) 1 2/848 (0.2%) 2 0/870 (0%) 0 1/1260 (0.1%) 1
    Haematoma 0/855 (0%) 0 1/848 (0.1%) 1 0/870 (0%) 0 0/1260 (0%) 0
    Orthostatic hypotension 1/855 (0.1%) 1 0/848 (0%) 0 0/870 (0%) 0 0/1260 (0%) 0
    Peripheral vascular disorder 0/855 (0%) 0 0/848 (0%) 0 0/870 (0%) 0 2/1260 (0.2%) 2
    Other (Not Including Serious) Adverse Events
    High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Standad Dose Inactivated, Split-Virion Influenza Vaccine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 455/855 (53.2%) 454/848 (53.5%) 449/870 (51.6%) 544/1260 (43.2%)
    General disorders
    Injection site erythema 136/855 (15.9%) 136 125/848 (14.7%) 125 123/870 (14.1%) 123 136/1260 (10.8%) 136
    Injection site pain 295/855 (34.5%) 295 292/848 (34.4%) 292 328/870 (37.7%) 328 306/1260 (24.3%) 306
    Injection site swelling 79/855 (9.2%) 79 76/848 (9%) 76 75/870 (8.6%) 75 73/1260 (5.8%) 73
    Malaise 173/855 (20.2%) 173 150/848 (17.7%) 150 139/870 (16%) 139 176/1260 (14%) 176
    Musculoskeletal and connective tissue disorders
    Myalgia 197/855 (23%) 197 175/848 (20.6%) 175 178/870 (20.5%) 178 230/1260 (18.3%) 230
    Nervous system disorders
    Headache 146/855 (17.1%) 146 138/848 (16.3%) 138 147/870 (16.9%) 147 182/1260 (14.4%) 182

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.

    Results Point of Contact

    Name/Title Medical Director
    Organization Sanofi Pasteur Inc.
    Phone
    Email RegistryContactUs@sanofipasteur.com
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00391053
    Other Study ID Numbers:
    • FIM05
    First Posted:
    Oct 23, 2006
    Last Update Posted:
    Apr 14, 2016
    Last Verified:
    Apr 1, 2016