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Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00551031
Collaborator
(none)
2,098
Enrollment
29
Locations
5
Arms
13
Duration (Months)
72.3
Patients Per Site
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present formulations are being developed for further study in the elderly population in order to generate additional supporting data.

Primary Objective:

To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects.

Secondary Objectives:

Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®.

Safety:

To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.

Condition or Disease Intervention/Treatment Phase
  • Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)
  • Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)
  • Biological: Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
  • Biological: Split, Inactivated, Trivalent Influenza Vaccine (High-dose)
  • Biological: Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
2098 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety of Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared With Standard Fluzone® in Adults and Elderly Subjects.
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Influenza Virus Vaccine Formulation 1

Influenza Virus Vaccine Formulation 1

Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)
0.1 mL, Intradermal (ID)
Experimental: Influenza Virus Vaccine Formulation 2

Influenza Virus Vaccine Formulation 2

Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)
0.1 mL, Intradermal (ID)
Active Comparator: Fluzone® Elderly Group

Biological: Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
0.5 mL, Intramuscular (IM)
Other Names:
  • Fluzone®

    		•
    Active Comparator: Fluzone® High-dose Group

    Participants enrolled at age ≥ 65 years

    Biological: Split, Inactivated, Trivalent Influenza Vaccine (High-dose)
    0.5 mL, Intramuscular (IM)
    Other Names:
  • Fluzone® High-dose

    		•
    Active Comparator: Fluzone® Adults Group

    Participants enrolled at age 18-49 years.

    Biological: Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
    0.5 mL, Intramuscular (IM)
    Other Names:
  • Fluzone®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. [Day 0 and Day 28 post vaccination]

      Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.

    2. Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine [Day 28 post-vaccination]

      Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.

    3. Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. [Day 0 and Day 28 post-vaccination]

      Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40

    Secondary Outcome Measures

    1. Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. [Days 0 through 7 post-vaccination]

      Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills

    Eligibility Criteria

    Criteria

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

    • Aged ≥ 65 years or aged 18 to 49 years on the day of vaccination.

    • Informed consent form signed.

    • Medically stable (Subjects may have underlying illnesses 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.

    • For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination

    Exclusion Criteria:

    • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances.

    • Known or suspected congenital or acquired immunodeficiency, hepatitis B (HBsAg) or hepatitis C infection or seropositivity immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy

    • For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test.

    • Breast feeding woman.

    • 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 use of alcohol or recreational drugs 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 3 months that might interfere with the assessment of immune response.

    • Vaccination against influenza in the past 6 months.

    • Any vaccination in the 4 weeks preceding the trial vaccination.

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

    • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination.

    • 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.

    • Known thrombocytopenia or bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.

    • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator

    • Personal or family history of Guillain-Barré Syndrome.

    • Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity.

    • 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 ≥ 99.5°F (≥ 37.5°C)] within 24 hours prior to vaccination. If this exists, vaccination will be deferred until the participant becomes afebrile.

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

    • The use of an antibiotics therapy within 72 hours preceding the trial vaccination. If this exists, vaccination will be deferred until at least 72 hours after the last antibiotics therapy.

    • Receipt of any allergy shots in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots in the 7-day period after enrollment (vaccination). Subjects should be enrolled in the trial only if their allergy shots are given on a stable schedule outside the 7-day periods pre- and post-vaccination.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabaster Alabama United States
    2 Mobile Alabama United States
    3 Chandler Arizona United States
    4 Mesa Arizona United States
    5 Phoenix Arizona United States
    6 Tucson Arizona United States
    7 Fountain Valley California United States
    8 San Diego California United States
    9 Stanford Connecticut United States
    10 Pembroke Pines Florida United States
    11 Pinellas Park Florida United States
    12 Boise Idaho United States
    13 Chicago Illinois United States
    14 Wichita Kansas United States
    15 Kansas City Missouri United States
    16 Springfield Missouri United States
    17 St. Louis Missouri United States
    18 Cary North Carolina United States
    19 Raleigh North Carolina United States
    20 Cincinnati Ohio United States
    21 Allentown Pennsylvania United States
    22 Bensalem Pennsylvania United States
    23 Warwick Rhode Island United States
    24 Goose Creek South Carolina United States
    25 Fort Worth Texas United States
    26 Galveston Texas United States
    27 Salt Lake City Utah United States
    28 West Jordan Utah United States
    29 Marshfield Wisconsin United States

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT00551031
    Other Study ID Numbers:
    • FID29
    First Posted:
    Oct 30, 2007
    Last Update Posted:
    May 16, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Sanofi
    Influenza
    Orthomyxoviruses
    Myxovirus Infection
    Inactivated Split-virion influenza vaccine
    Elderly
    Additional relevant MeSH terms:
    Influenza, Human
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled from 24 October to 31 October 2007 in 31 medical centers in the US.
    Pre-assignment Detail A total of 2095 of the 2098 enrolled participants who met the inclusion and exclusion criteria were vaccinated.
    Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
    Arm/Group Description Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM) Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM) Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
    Period Title: Overall Study
    STARTED 637 636 319 320 186
    COMPLETED 635 625 317 317 185
    NOT COMPLETED 2 11 2 3 1

    Baseline Characteristics

    Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group Total
    Arm/Group Description Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM) Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM) Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM) Total of all reporting groups
    Overall Participants 635 635 319 320 186 2095
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    186
    100%
    186
    8.9%
    >=65 years
    635
    100%
    635
    100%
    319
    100%
    320
    100%
    0
    0%
    1909
    91.1%
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    73.1
    (6.03)
    72.9
    (5.86)
    73.4
    (5.91)
    73.0
    (6.00)
    32.2
    (8.49)
    64.8
    (6.458)
    Sex: Female, Male (Count of Participants)
    Female
    363
    57.2%
    347
    54.6%
    176
    55.2%
    183
    57.2%
    121
    65.1%
    1190
    56.8%
    Male
    272
    42.8%
    288
    45.4%
    143
    44.8%
    137
    42.8%
    65
    34.9%
    905
    43.2%
    Region of Enrollment (Number) [Number]
    United States
    635
    100%
    635
    100%
    319
    100%
    320
    100%
    186
    100%
    2095
    100%

    Outcome Measures

    1. Primary Outcome
    Title Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
    Description Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.
    Time Frame Day 0 and Day 28 post vaccination

    Outcome Measure Data

    Analysis Population Description
    Serum antibody titers GMTs were assessed in the per-protocol population.
    Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
    Arm/Group Description Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM) Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM) Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
    Measure Participants 607 608 304 309 179
    A/H1N1 Pre Dose (N=604, 607, 304, 309, 179)
    18.3
    18.6
    17.8
    17.3
    41.4
    A/H1N1 Post Dose (N=605, 607, 304, 309, 179)
    165.4
    174.1
    107.6
    236.1
    345.8
    A/H3N2 Pre Dose (N=606, 608, 304, 309, 179)
    103.8
    104.7
    95.1
    99.3
    73.0
    A/H3N2 Post Dose (N=605, 608, 304, 309, 179)
    348.3
    378.4
    276.9
    508.0
    398.3
    B Pre Dose (N=607, 608, 304, 309, 179)
    24.7
    25.1
    24.7
    24.1
    15.5
    B Post Dose (N=607, 608, 304, 309, 179)
    45.3
    47.5
    43.4
    59.9
    71.2
    2. Primary Outcome
    Title Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine
    Description Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.
    Time Frame Day 28 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Serum antibody titers were assessed in the per protocol population.
    Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
    Arm/Group Description Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM) Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM) Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
    Measure Participants 607 608 304 309 179
    A/H1N1 (N=604, 607, 304, 309, 179)
    73
    11.5%
    74
    11.7%
    61
    19.1%
    82
    25.6%
    62
    33.3%
    A/H3N2 (N=605, 608, 304, 309, 179)
    42
    6.6%
    42
    6.6%
    37
    11.6%
    56
    17.5%
    52
    28%
    B (N=607, 608, 304, 309, 179)
    15
    2.4%
    15
    2.4%
    9
    2.8%
    26
    8.1%
    44
    23.7%
    3. Primary Outcome
    Title Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
    Description Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40
    Time Frame Day 0 and Day 28 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Serum antibody titers were assessed in the per protocol population.
    Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
    Arm/Group Description Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM) Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM) Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
    Measure Participants 607 608 304 309 179
    A/H1N1 Pre Dose (N=604, 607, 304, 309, 179)
    27
    4.3%
    25
    3.9%
    25
    7.8%
    23
    7.2%
    49
    26.3%
    A/H1N1 Post Dose (N=605, 607, 304, 309, 179)
    88
    13.9%
    90
    14.2%
    79
    24.8%
    94
    29.4%
    97
    52.2%
    A/H3N2 Pre Dose (N=606, 608, 304, 309, 179)
    78
    12.3%
    79
    12.4%
    80
    25.1%
    78
    24.4%
    72
    38.7%
    A/H3N2 Post Dose (N=605, 608, 304, 309, 179)
    98
    15.4%
    98
    15.4%
    97
    30.4%
    99
    30.9%
    99
    53.2%
    B Pre Dose (N=607, 608, 304, 309, 179)
    38
    6%
    37
    5.8%
    39
    12.2%
    37
    11.6%
    25
    13.4%
    B Post Dose (N=607, 608, 304, 309, 179)
    65
    10.2%
    67
    10.6%
    62
    19.4%
    77
    24.1%
    79
    42.5%
    4. Secondary Outcome
    Title Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
    Description Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills
    Time Frame Days 0 through 7 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent to treat population.
    Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
    Arm/Group Description Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM) Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM) Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
    Measure Participants 635 635 319 320 186
    Any Injection Site Pain
    174
    27.4%
    187
    29.4%
    57
    17.9%
    117
    36.6%
    106
    57%
    Grade 3 Pain (Prevents daily activities)
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Any Injection Site Pruritus
    204
    32.1%
    214
    33.7%
    27
    8.5%
    17
    5.3%
    24
    12.9%
    Grade 3 Pruritus (Prevents daily activities)
    2
    0.3%
    3
    0.5%
    0
    0%
    0
    0%
    0
    0%
    Any Injection Site Erythema
    426
    67.1%
    434
    68.3%
    48
    15%
    55
    17.2%
    29
    15.6%
    Grade 3 Erythema (≥ 5 cm)
    109
    17.2%
    108
    17%
    5
    1.6%
    12
    3.8%
    5
    2.7%
    Any Injection Site Swelling
    286
    45%
    286
    45%
    23
    7.2%
    45
    14.1%
    14
    7.5%
    Grade 3 Swelling (≥ 5 cm)
    50
    7.9%
    49
    7.7%
    6
    1.9%
    16
    5%
    1
    0.5%
    Any Injection Site Induration
    310
    48.8%
    311
    49%
    33
    10.3%
    45
    14.1%
    20
    10.8%
    Grade 3 Induration (≥ 5 cm)
    41
    6.5%
    43
    6.8%
    5
    1.6%
    12
    3.8%
    4
    2.2%
    Any Injection Site Ecchymosis
    38
    6%
    41
    6.5%
    19
    6%
    17
    5.3%
    14
    7.5%
    Grade 3 Ecchymosis (≥ 5 cm)
    5
    0.8%
    9
    1.4%
    2
    0.6%
    2
    0.6%
    2
    1.1%
    Any Fever
    14
    2.2%
    18
    2.8%
    5
    1.6%
    17
    5.3%
    10
    5.4%
    Grade 3 Fever (> 102.2 ºF)
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.5%
    Any Headache
    103
    16.2%
    89
    14%
    41
    12.9%
    59
    18.4%
    61
    32.8%
    Grade 3 Headache (Prevents daily activities)
    2
    0.3%
    6
    0.9%
    1
    0.3%
    2
    0.6%
    2
    1.1%
    Any Malaise
    76
    12%
    98
    15.4%
    42
    13.2%
    50
    15.6%
    45
    24.2%
    Grade 3 Malaise (Prevents daily activities)
    5
    0.8%
    3
    0.5%
    0
    0%
    3
    0.9%
    6
    3.2%
    Any Myalgia
    86
    13.5%
    106
    16.7%
    46
    14.4%
    79
    24.7%
    68
    36.6%
    Grade 3 Myalgia (Prevents daily activities)
    2
    0.3%
    2
    0.3%
    1
    0.3%
    3
    0.9%
    1
    0.5%
    Any Chills
    21
    3.3%
    32
    5%
    9
    2.8%
    28
    8.8%
    17
    9.1%
    Grade 3 Chills (Prevents daily activities)
    0
    0%
    3
    0.5%
    0
    0%
    2
    0.6%
    2
    1.1%

    Adverse Events

    Time Frame Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
    Adverse Event Reporting Description
    Arm/Group Title Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
    Arm/Group Description Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM) Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM) Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
    All Cause Mortality
    Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 34/635 (5.4%) 38/635 (6%) 21/319 (6.6%) 16/320 (5%) 7/186 (3.8%)
    Blood and lymphatic system disorders
    Microcytic anaemia 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Cardiac disorders
    Acute myocardial infarction 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 1/320 (0.3%) 1 0/186 (0%) 0
    Angina pectoris 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Atrial fibrillation 2/635 (0.3%) 2 1/635 (0.2%) 1 2/319 (0.6%) 2 0/320 (0%) 0 0/186 (0%) 0
    Cardiac arrest 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Cardiac failure 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Cardiac failure congestive 1/635 (0.2%) 1 1/635 (0.2%) 1 1/319 (0.3%) 1 1/320 (0.3%) 1 0/186 (0%) 0
    Cardiovascular disorder 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Coronary artery disease 1/635 (0.2%) 1 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Ventricular tachycardia 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 1/186 (0.5%) 1
    Ear and labyrinth disorders
    Meniere's disease 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Vertigo 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Colitis ulcerative 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 1/319 (0.3%) 1 0/186 (0%) 0
    Gastric ulcer 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Gasgtrooesophageal reflux disease 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 1/320 (0.3%) 1 0/186 (0%) 0
    Intestinal perforation 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Large intestine perforation 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Oesophagitis 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Pancreatitis 1/635 (0.2%) 1 2/635 (0.3%) 2 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Pancreatitis acute 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Small intestinal obstruction 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    General disorders
    Chest pain 0/635 (0%) 0 2/635 (0.3%) 2 0/319 (0%) 0 2/319 (0.6%) 2 1/186 (0.5%) 1
    Influenza like illness 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Non cardiac chest pain 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 1/186 (0.5%) 1
    Pain 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Hepatobiliary disorders
    Biliary colic 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Gallbladder disorder 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Hepatic failure 0/635 (0%) 0 1/635 (0.2%) 1 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Immune system disorders
    Drug hypersensitivity 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 1/320 (0.3%) 1 0/186 (0%) 0
    Hypersensitivity 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Infections and infestations
    Bronchitis 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Cellulitis 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Clostridial infection 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Diverticulitis 1/635 (0.2%) 1 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Infection 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Influenza 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 1/320 (0.3%) 1 0/186 (0%) 0
    Otitis media 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 1/320 (0.3%) 1 0/186 (0%) 0
    Pneumonia 0/635 (0%) 0 2/635 (0.3%) 2 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Viral infection 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Injury, poisoning and procedural complications
    Cardiac pacemaker malfunction 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Dislocation of joint prosthesis 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Head injury 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Hip fracture 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Humerus fracture 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Joint injury 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Procedural pain 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Renal haematoma 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Spinal compression fracture 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Stent graft material failure 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Subdural haematoma 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    International normalised ratio increased 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 1/320 (0.3%) 1 1/186 (0.5%) 1
    Hypokalaemia 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Hyponatraemia 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Intervertebral disc protrusion 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Muscular weakness 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 1/320 (0.3%) 1 0/186 (0%) 0
    Neck pain 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Osteoarthritis 2/635 (0.3%) 2 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Rhabdomyolysis 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 1/320 (0.3%) 1 0/186 (0%) 0
    Rotator cuff syndrome 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Breast cancer 1/635 (0.2%) 1 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Chronic lymphocytic leukaemia 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Colon cancer 1/635 (0.2%) 1 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Lung adenocarcinoma 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Lung neoplasm malignant 0/635 (0%) 0 2/635 (0.3%) 2 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Pancreatic carcinoma 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Prostate cancer 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 1/320 (0.3%) 1 0/186 (0%) 0
    Prostate cancer recurrent 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Small cell lung cancer metastatic 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 1/320 (0.3%) 1 0/186 (0%) 0
    Nervous system disorders
    Carotid artery stenosis 1/635 (0.2%) 1 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Cerebrovascular accident 1/635 (0.2%) 1 1/635 (0.2%) 1 3/319 (0.9%) 3 0/320 (0%) 0 0/186 (0%) 0
    Intracranial aneurysm 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Lumbar radiculopathy 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Presyncope 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Syncope 2/635 (0.3%) 2 0/635 (0%) 0 1/319 (0.3%) 1 2/320 (0.6%) 2 1/186 (0.5%) 1
    Thrombotic stroke 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 1/320 (0.3%) 1 0/186 (0%) 0
    Transient ischaemic attack 2/635 (0.3%) 2 2/635 (0.3%) 2 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Psychiatric disorders
    Depression 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Renal and urinary disorders
    Bladder prolapse 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Renal failure acute 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Urinary incontinence 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/635 (0%) 0 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 1/186 (0.5%) 1
    Chronic obstructive pulmonary disease 1/635 (0.2%) 1 2/635 (0.3%) 2 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Hypoxia 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Pharyngeal mass 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Respiratory failure 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 0/186 (0%) 0
    Status asthmaticus 0/635 (0%) 0 0/635 (0%) 0 1/319 (0.3%) 1 0/320 (0%) 0 1/186 (0.5%) 1
    Vascular disorders
    Arteriosclerosis 1/635 (0.2%) 1 0/635 (0%) 0 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Peripheral vascular disorder 0/635 (0%) 0 1/635 (0.2%) 1 0/319 (0%) 0 0/320 (0%) 0 0/186 (0%) 0
    Other (Not Including Serious) Adverse Events
    Influenza Virus Vaccine Formulation 1 Influenza Virus Vaccine Formulation 2 Fluzone® Elderly Group Fluzone® High Dose Group Fluzone® Adults Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 426/635 (67.1%) 434/635 (68.3%) 57/319 (17.9%) 117/320 (36.6%) 106/186 (57%)
    General disorders
    Injection site pain 174/635 (27.4%) 174 187/632 (29.6%) 187 57/319 (17.9%) 57 117/318 (36.8%) 117 106/185 (57.3%) 106
    Injection site pruritus 204/635 (32.1%) 204 214/632 (33.9%) 214 27/319 (8.5%) 27 17/318 (5.3%) 17 24/185 (13%) 24
    Injection site erythema 426/635 (67.1%) 426 434/632 (68.7%) 434 48/319 (15%) 48 55/319 (17.2%) 55 29/185 (15.7%) 29
    Injection site swelling 286/635 (45%) 286 286/631 (45.3%) 286 23/319 (7.2%) 23 45/319 (14.1%) 45 14/185 (7.6%) 14
    Injection site induration 310/635 (48.8%) 310 311/631 (49.3%) 311 33/319 (10.3%) 33 45/319 (14.1%) 45 20/185 (10.8%) 20
    Injection site ecchymosis 38/634 (6%) 38 41/631 (6.5%) 41 19/319 (6%) 19 17/319 (5.3%) 17 14/185 (7.6%) 14
    Fever 14/630 (2.2%) 14 18/630 (2.9%) 18 5/319 (1.6%) 5 17/318 (5.3%) 17 10/182 (5.5%) 10
    Malaise 76/634 (12%) 76 98/631 (15.5%) 98 42/319 (13.2%) 42 50/319 (15.7%) 50 45/185 (24.3%) 45
    Chills 21/634 (3.3%) 21 32/632 (5.1%) 32 9/319 (2.8%) 9 28/319 (8.8%) 28 17/185 (9.2%) 17
    Musculoskeletal and connective tissue disorders
    Myalgia 86/634 (13.6%) 86 106/632 (16.8%) 106 46/319 (14.4%) 46 79/319 (24.8%) 79 68/185 (36.8%) 68
    Nervous system disorders
    Headache 103/634 (16.2%) 103 89/632 (14.1%) 89 41/319 (12.9%) 41 59/319 (18.5%) 59 61/185 (33%) 61

    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
    ClinicalTrials.gov Identifier:
    NCT00551031
    Other Study ID Numbers:
    • FID29
    First Posted:
    Oct 30, 2007
    Last Update Posted:
    May 16, 2016
    Last Verified:
    Apr 1, 2016