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Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages (SLVP015 2007-2017)

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT01827462
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
136
Enrollment
1
Location
3
Arms
113
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study the investigators are trying to understand how immune function declines in the elderly using annual influenza vaccinations as a model system. The longitudinal study began in 2007 and continued through early 2017.

Condition or Disease Intervention/Treatment Phase
  • Biological: Trivalent, inactivated influenza vaccine (TIV)
  • Biological: Quadrivalent, inactivated influenza vaccine (IIV4)
  • Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
 Phase 4

Detailed Description

Participants ranging in age from 18 to 100 at time of initial enrollment will be immunized annually with the seasonal influenza vaccine, Fluzone, on Day 0. Follow-up visits will be conducted on Day 6-8 and Day 28. Unsolicited adverse events are collected from immunization until the Day 28 visit, serious adverse events are collected for the entire time of study participation. A blood sample is collected pre-immunization and at each follow-up visit. Volunteers will be followed for up to 11 years, those too frail to come in for visits received annual phone calls to monitor health. Last annual influenza vaccines were given in Fall 2015.

The main basic research effort will be to collect safety data and follow medical history events in elderly and younger control subjects. Investigators will also look at immune responses to influenza vaccination. In 2008, 2012 and 2014, the cohort added additional participants to replace those who had withdrawn.

Beginning in 2014, those participants 65 years and older were immunized with High Dose trivalent Fluzone and younger participants received the quadrivalent formulation of Fluzone.

Study Design

Study Type:
Interventional
Actual Enrollment :
136 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Immune Senescence in the Elderly: Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages
Actual Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 18-30 year olds at enrollment

Licensed seasonal Fluzone (inactivated influenza vaccine): Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season. Beginning with 2014-2015 season, Quadrivalent, inactivated influenza vaccine (IIV4) was given.

Biological: Trivalent, inactivated influenza vaccine (TIV)
Licensed Seasonal Influenza Vaccine TIV
Other Names:
  • Fluzone (IM)

    • Biological: Quadrivalent, inactivated influenza vaccine (IIV4)
    Licensed Seasonal Influenza Vaccine IIV4
    Other Names:
  • Fluzone (IM)

    		•
    Experimental: 60-80 year olds at enrollment

    Licensed seasonal Fluzone (inactivated influenza vaccine): Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season. Beginning with 2014-2015 season, High-Dose trivalent, inactivated influenza vaccine (TIV High-Dose) was given.

    Biological: Trivalent, inactivated influenza vaccine (TIV)
    Licensed Seasonal Influenza Vaccine TIV
    Other Names:
  • Fluzone (IM)

    • Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
    Licensed Seasonal High-Dose Influenza Vaccine TIV
    Other Names:
  • Fluzone High-Dose (IM)

    		•
    Experimental: 80-100 year olds at enrollment

    Licensed seasonal Fluzone (inactivated influenza vaccine): Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season. Beginning with 2014-2015 season, High-Dose trivalent, inactivated influenza vaccine (TIV High-Dose) was given.

    Biological: Trivalent, inactivated influenza vaccine (TIV)
    Licensed Seasonal Influenza Vaccine TIV
    Other Names:
  • Fluzone (IM)

    • Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
    Licensed Seasonal High-Dose Influenza Vaccine TIV
    Other Names:
  • Fluzone High-Dose (IM)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Received the Influenza Vaccine [Day 0 annually while on study]

    Secondary Outcome Measures

    1. Number of Participants With Related Adverse Events [Day 0 to Day 28 following each annual vaccination while on study]

      Related adverse events were recorded annually during this 10 year longitudinal study.

    Other Outcome Measures

    1. Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 5-7 for T Cells and Antibody-secreting Cells (ASCs) [Day 0 to 7]

    2. Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 28-32 for Responses to the Vaccine Antigens [Day 0-Day28]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age 18-30, 60-79, or 80-100 years, inclusive at time of initial enrollment

    • General good health and ambulatory at time of enrollment

    • No acute illness at time of vaccination

    • Willing and able to sign Informed Consent

    • Available for follow-up for the planned duration of the study

    • Acceptable medical history by screening evaluation and brief clinical assessment

    • All female subjects of childbearing potential must use an acceptable method of contraception and not become pregnant for the duration of the clinical phase of the study (approximately 1 month to completion of Visit 3). (Acceptable contraception may include implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).

    Exclusion Criteria:

    • Prior off-study vaccination with trivalent or quadrivalent (depending no year) influenza vaccine (TIV or IIV4) or live attenuated influenza vaccine (LAIV) in the current flu season

    • Allergy to egg or egg products

    • Allergy to vaccine components, including thimerosal

    • Active systemic or serious concurrent illness, including febrile illness on the day of vaccination

    • History of immunodeficiency

    • Any chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.

    • Blood pressure >150 systolic or > 95 diastolic at Visit 1

    • Chronic Hepatitis B or C.

    • Recent or current use of systemic immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays and inhaled steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.

    • Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.

    • History of blood dyscrasias or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year

    • Use of anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin, Plavix, Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.

    • Receipt of blood or blood products within the past 6 months

    • Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol

    • Receipt of inactivated vaccine within 14 days prior to vaccination

    • Receipt of live, attenuated vaccine within 60 days of vaccination

    • History of Guillain-Barré Syndrome

    • Pregnant or lactating woman

    • Use of investigational agents within 30 days prior to enrollment

    • Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment

    • Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University
    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Cornelia L Dekker, MD, Stanford University
    • Principal Investigator: Mark M Davis, PhD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Cornelia L. Dekker, Professor, Pediatrics, Stanford University
    ClinicalTrials.gov Identifier:
    NCT01827462
    Other Study ID Numbers:
    • SU-03192011-7599
    • 1U19AI090019-01
    • 51731
    • AG-NS-0792-11
    First Posted:
    Apr 9, 2013
    Last Update Posted:
    Jul 11, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Cornelia L. Dekker, Professor, Pediatrics, Stanford University
    Inactivated, trivalent influenza vaccine
    elderly
    immunosenescence
    longitudinal study
    Inactivated, High-Dose trivalent influenza vaccine
    Inactivated, quadrivalent influenza vaccine
    young adults
    Additional relevant MeSH terms:
    Influenza, Human
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 18-30 Years Old at Enrollment 60-79 Years Old at Enrollment 80-100 Years Old at Enrollment
    Arm/Group Description Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly
    Period Title: Overall Study
    STARTED 59 37 40
    COMPLETED 18 19 12
    NOT COMPLETED 41 18 28

    Baseline Characteristics

    Arm/Group Title 18-30 Years Old at Enrollment 60-79 Years Old at Enrollment 80-100 Years Old at Enrollment Total
    Arm/Group Description Participants receive the licensed annual, Fluzone® This vaccine is given intramuscularly Participants receive the licensed annual vaccine, Fluzone® This vaccine is given intramuscularly Participants receive the licensed annual vaccine, Fluzone® or High Dose Fluzone® This vaccine is given intramuscularly Total of all reporting groups
    Overall Participants 59 37 40 136
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    29.6
    (2.9)
    73.3
    (5.0)
    89.5
    (4.3)
    70.9
    (23.1)
    Sex: Female, Male (Count of Participants)
    Female
    30
    50.8%
    22
    59.5%
    26
    65%
    78
    57.4%
    Male
    29
    49.2%
    15
    40.5%
    14
    35%
    58
    42.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    6
    10.2%
    0
    0%
    0
    0%
    6
    4.4%
    Not Hispanic or Latino
    53
    89.8%
    37
    100%
    40
    100%
    130
    95.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    12
    20.3%
    0
    0%
    1
    2.5%
    13
    9.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    37
    62.7%
    37
    100%
    37
    92.5%
    111
    81.6%
    More than one race
    8
    13.6%
    0
    0%
    2
    5%
    10
    7.4%
    Unknown or Not Reported
    2
    3.4%
    0
    0%
    0
    0%
    2
    1.5%
    Region of Enrollment (participants) [Number]
    United States
    59
    100%
    37
    100%
    40
    100%
    136
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Who Received the Influenza Vaccine
    Description
    Time Frame Day 0 annually while on study

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 18-30 Years Old at Enrollment 60-79 Years Old at Enrollment 80-100 Years Old at Enrollment
    Arm/Group Description Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly
    Measure Participants 59 37 40
    Count of Participants [Participants]
    59
    100%
    37
    100%
    40
    100%
    2. Secondary Outcome
    Title Number of Participants With Related Adverse Events
    Description Related adverse events were recorded annually during this 10 year longitudinal study.
    Time Frame Day 0 to Day 28 following each annual vaccination while on study

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 18-30 Years Old at Enrollment 60-79 Years Old at Enrollment 80-100 Years Old at Enrollment
    Arm/Group Description Participants receive the licensed annual trivalent vaccine, Fluzone® through 2013-2014 then received licensed annual quadrivalent Fluzone. This vaccine is given intramuscularly Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season. For the following seasons, they received Fluzone High-Dose. This vaccine is given intramuscularly Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season. For the following seasons, they received Fluzone High-Dose. This vaccine is given intramuscularly
    Measure Participants 59 37 40
    Erythema at injection site
    0
    0%
    0
    0%
    1
    2.5%
    Rash at injection site
    0
    0%
    0
    0%
    1
    2.5%
    Pain at injection site
    1
    1.7%
    0
    0%
    0
    0%
    Flushing
    0
    0%
    1
    2.7%
    0
    0%
    High White Blood Cell Count
    0
    0%
    1
    2.7%
    0
    0%
    Lymphopenia
    0
    0%
    0
    0%
    1
    2.5%
    Thrombocytopenia
    1
    1.7%
    0
    0%
    0
    0%
    No Related Adverse Events
    57
    96.6%
    35
    94.6%
    37
    92.5%
    3. Other Pre-specified Outcome
    Title Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 5-7 for T Cells and Antibody-secreting Cells (ASCs)
    Description
    Time Frame Day 0 to 7

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Other Pre-specified Outcome
    Title Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 28-32 for Responses to the Vaccine Antigens
    Description
    Time Frame Day 0-Day28

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study.
    Adverse Event Reporting Description Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
    Arm/Group Title 18-30 Years Old at Enrollment 60-79 Years Old at Enrollment 80-100 Years Old at Enrollment
    Arm/Group Description Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed quadrivalent vaccine, Fluzone starting with the 2014-2015 season. This vaccine is given intramuscularly Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season. This vaccine is given intramuscularly Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season. This vaccine is given intramuscularly
    All Cause Mortality
    18-30 Years Old at Enrollment 60-79 Years Old at Enrollment 80-100 Years Old at Enrollment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/59 (0%) 2/37 (5.4%) 16/40 (40%)
    Serious Adverse Events
    18-30 Years Old at Enrollment 60-79 Years Old at Enrollment 80-100 Years Old at Enrollment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/59 (3.4%) 20/37 (54.1%) 34/40 (85%)
    Cardiac disorders
    Myocardial Infarction 0/59 (0%) 0 0/37 (0%) 0 3/40 (7.5%) 3
    Congestive Heart Failure 0/59 (0%) 0 1/37 (2.7%) 1 6/40 (15%) 6
    Atrial Fibrillation 0/59 (0%) 0 2/37 (5.4%) 2 2/40 (5%) 2
    Hypetension 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Hypotension 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Chest Pain 0/59 (0%) 0 1/37 (2.7%) 1 1/40 (2.5%) 1
    Calcium Channel Blocker Overdose 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Bradycardia 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Pericarditis 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Syncopal Episode 0/59 (0%) 0 0/37 (0%) 0 0/40 (0%) 0
    Death 0/59 (0%) 0 0/37 (0%) 0 3/40 (7.5%) 3
    Gastrointestinal disorders
    Ulcer 0/59 (0%) 0 2/37 (5.4%) 2 1/40 (2.5%) 1
    Gastroesophageal reflux disease 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Diverticulitis 0/59 (0%) 0 1/37 (2.7%) 1 1/40 (2.5%) 1
    Abdominal Pain 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Nausea/Vomiting 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    General disorders
    Diminished Cognition 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Weakness Worsening 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Death 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Death 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Death 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Infections and infestations
    Pneumonia 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Prosthetic Hip Infection 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 3
    Cellulitis 0/59 (0%) 0 1/37 (2.7%) 1 1/40 (2.5%) 1
    Systemic Inflammatory Response Syndrone 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Scabies 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Death 0/59 (0%) 0 0/37 (0%) 0 2/40 (5%) 2
    Metabolism and nutrition disorders
    Alcohol Detoxification 1/59 (1.7%) 1 0/37 (0%) 0 0/40 (0%) 0
    Musculoskeletal and connective tissue disorders
    Fractures/Accidents 0/59 (0%) 0 1/37 (2.7%) 1 3/40 (7.5%) 6
    Contusions/observation/hit by car 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Degenerative Joint Disease-pain 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung Cancer 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Prostate Cancer 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Pancreatic Cancer 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Ovarian Cancer 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Death 0/59 (0%) 0 1/37 (2.7%) 1 1/40 (2.5%) 1
    Death 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Death 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Death 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Death 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Nervous system disorders
    Parkinson's 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Syncopal Episode 0/59 (0%) 0 0/37 (0%) 0 2/40 (5%) 2
    Psychiatric disorders
    Depression 1/59 (1.7%) 1 0/37 (0%) 0 1/40 (2.5%) 1
    Renal and urinary disorders
    UTI 0/59 (0%) 0 0/37 (0%) 0 3/40 (7.5%) 3
    Urosepsis 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/59 (0%) 0 1/37 (2.7%) 2 0/40 (0%) 0
    Pneumonia 0/59 (0%) 0 1/37 (2.7%) 1 5/40 (12.5%) 7
    Bronchiectasis 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Pleural Effusions/bilateral 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Pneumothorax 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    COPD 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Surgical and medical procedures
    Appendectomy 1/59 (1.7%) 1 0/37 (0%) 0 1/40 (2.5%) 1
    Hip Arthroplasty 0/59 (0%) 0 2/37 (5.4%) 4 7/40 (17.5%) 9
    Knee Arthroplasty 0/59 (0%) 0 2/37 (5.4%) 3 0/40 (0%) 0
    Bladder resection/transurethral 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Diaphragmatic Hernia Repair 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Microdiskectomy 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Pancreatoduodenectomy 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Perforated Pylric Ulcer repair 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Inguinal Hernia Repair 0/59 (0%) 0 1/37 (2.7%) 1 1/40 (2.5%) 1
    Pacemaker Placement 0/59 (0%) 0 1/37 (2.7%) 1 1/40 (2.5%) 1
    Node Ablation 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Hemicolectomy 0/59 (0%) 0 0/37 (0%) 0 0/40 (0%) 0
    Aortic Valve Replacement 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Arthrectomy-Femoral Artery 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Decompression of Lumbar Stenosis 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Femur Fracture Repair 0/59 (0%) 0 0/37 (0%) 0 2/40 (5%) 2
    Cardioversion 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Cholecystectomy 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Colectomy 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Pancreatic Stent Placement 0/59 (0%) 0 1/37 (2.7%) 1 1/40 (2.5%) 1
    Biliary Stent Placement 0/59 (0%) 0 1/37 (2.7%) 1 1/40 (2.5%) 1
    Inferior Vena Cava Filter 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Venoplasty 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Diverticulectomy 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Ankle Fracture 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Vascular disorders
    Amnesia-Tansient 0/59 (0%) 0 1/37 (2.7%) 1 0/40 (0%) 0
    Stroke 0/59 (0%) 0 2/37 (5.4%) 2 3/40 (7.5%) 3
    Subarachnoid Hemorrhage 0/59 (0%) 0 0/37 (0%) 0 2/40 (5%) 2
    Death 0/59 (0%) 0 0/37 (0%) 0 1/40 (2.5%) 1
    Death 0/59 (0%) 0 1/37 (2.7%) 1 2/40 (5%) 2
    Other (Not Including Serious) Adverse Events
    18-30 Years Old at Enrollment 60-79 Years Old at Enrollment 80-100 Years Old at Enrollment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 31/59 (52.5%) 29/37 (78.4%) 21/40 (52.5%)
    Blood and lymphatic system disorders
    Anemia 0/59 (0%) 0 2/37 (5.4%) 2 4/40 (10%) 4
    Gastrointestinal disorders
    Diarrhea 0/59 (0%) 0 3/37 (8.1%) 3 1/40 (2.5%) 1
    Infections and infestations
    Upper respiratory infection 14/59 (23.7%) 15 15/37 (40.5%) 17 5/40 (12.5%) 5
    Urinary Tract Infection 2/59 (3.4%) 2 2/37 (5.4%) 3 3/40 (7.5%) 4
    Musculoskeletal and connective tissue disorders
    Lower Back Pain 1/59 (1.7%) 1 3/37 (8.1%) 3 3/40 (7.5%) 3
    Respiratory, thoracic and mediastinal disorders
    Influenza Type Illness 7/59 (11.9%) 7 2/37 (5.4%) 3 0/40 (0%) 0
    Rhinitis 7/59 (11.9%) 7 1/37 (2.7%) 1 1/40 (2.5%) 1
    Pneumonia 0/59 (0%) 0 1/37 (2.7%) 1 4/40 (10%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr Cornelia Dekker
    Organization Stanford University School of Medicine, Dept. of Pediatrics
    Phone 650-724-4437
    Email cdekker@stanford.edu
    Responsible Party:
    Cornelia L. Dekker, Professor, Pediatrics, Stanford University
    ClinicalTrials.gov Identifier:
    NCT01827462
    Other Study ID Numbers:
    • SU-03192011-7599
    • 1U19AI090019-01
    • 51731
    • AG-NS-0792-11
    First Posted:
    Apr 9, 2013
    Last Update Posted:
    Jul 11, 2017
    Last Verified:
    Jun 1, 2017