Influenza
Conditions
Keywords
Intramuscular inactivated trivalent influenza vaccine, Intradermal inactivated trivalent influenza vaccine, Live, attenuated influenza vaccine, Young adults
Brief summary
The purpose of this study is to investigate the responses to licensed trivalent, inactivated influenza vaccine (TIV) delivered by different routes: intramuscular (IM) and intradermal (ID) and to the live, attenuated influenza vaccine (LAIV) administered intranasally -- all given to generally healthy male and female adult volunteers.
Detailed description
The aim of this study is to compare the response to different formulations of licensed influenza vaccines. The type of seasonal influenza vaccination(s) received independently by volunteers in the year(s) since their last study visit will not impact eligibility. Volunteers will be assigned into one of three vaccine groups (intramuscular trivalent inactivated influenza vaccine (TIV); live attenuated influenza vaccine (LAIV- given year 1 only) or intradermal TIV, based on the type of study vaccine they received in 2010, 2011, 2012, or 2013. All participants will receive a single dose of their assigned seasonal influenza vaccine. Volunteers will complete 3 study visits at Day 0, Day 6-8 and Day 24-32.
Interventions
BIOLOGICAL2011-2012 FluMist®
This vaccine is given intranasally
BIOLOGICALFluzone® (IM)
This vaccine is given intramuscularly (IM)
BIOLOGICALFluzone® Intradermal (ID)
This vaccine is given intradermally (ID)
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 34 Years
Healthy volunteers
Yes
Inclusion criteria
* Otherwise healthy, ambulatory between the ages of 8-33 years, inclusively. * Willing to complete the informed consent process * Availability for follow-up for the planned duration of the study at least 28 days after immunization * Acceptable medical history and vital signs
Exclusion criteria
* Prior vaccination with seasonal TIV or LAIV * Prior off-study vaccination with TIV or LAIV in the current flu season * Allergy to egg or egg products, or to vaccine components or thimerosal (TIV multidose vials only) * Life-threatening reactions to previous influenza vaccinations * Active systemic or serious concurrent illness, including febrile illness on the day of vaccination * Asthma or history of wheezing (for volunteers receiving LAIV only) * Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (for volunteers receiving LAIV only) * History of immunodeficiency (including HIV infection) * Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other 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 first study visit * Chronic Hepatitis B or C * Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays, inhaled steroids and topical steroids are permissible in both groups) * Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia) * 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, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year * Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. aspirin per day), Plavix, or 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 or planned receipt of blood products prior to completion of study visits * Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol * Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination prior to completion of Visit 03 (\ Day 28 after the study vaccination) * Live, attenuated vaccine within 60 days of vaccination or planned non-study vaccination prior to completion of Visit 03 (\ Day 28 after the study vaccination) * Need an allergy immunization (that cannot be postponed) during the study period V01 to V03 (\ Day 28) * History of Guillain-Barré Syndrome * Pregnant or lactating woman * Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits * Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned blood donation prior to completion of study visits * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants From Each Arm Who Received Influenza Vaccine | Baseline to Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Related Adverse Events | Baseline to Day 28 | Number of participants with Related Adverse Events with a 0% Frequency Threshold |
Other
| Measure | Time frame |
|---|---|
| Frequency of Vaccine-specific Antibody Secreting Cells on Day 5 and Day 7 After Vaccination | Baseline to Day 7 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Fluzone® (IM) Participants in this group will be randomized to Fluzone® administered intramuscularly (IM) | 42 |
| Group B Fluzone® (ID) Participants in this group will be randomized to Fluzone® administered intradermally (ID) | 19 |
| Group C FluMist® Participants in this group will be randomized to FluMist® administered intranasally. | 25 |
| Total | 86 |
Baseline characteristics
| Characteristic | Group A Fluzone® (IM) | Group B Fluzone® (ID) | Group C FluMist® | Total |
|---|---|---|---|---|
| Age, Customized Age 18-30 years | 32 Participants | 19 Participants | 25 Participants | 76 Participants |
| Age, Customized Age 8-17 years | 10 Participants | 0 Participants | 0 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 1 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 16 Participants | 24 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 6 Participants | 9 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 25 Participants | 10 Participants | 9 Participants | 44 Participants |
| Region of Enrollment United States | 42 Participants | 19 Participants | 25 Participants | 86 Participants |
| Sex: Female, Male Female | 25 Participants | 9 Participants | 15 Participants | 49 Participants |
| Sex: Female, Male Male | 17 Participants | 10 Participants | 10 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 19 | 0 / 25 |
| other Total, other adverse events | 3 / 42 | 3 / 19 | 2 / 25 |
| serious Total, serious adverse events | 1 / 42 | 0 / 19 | 1 / 25 |
Outcome results
Primary
Number of Participants From Each Arm Who Received Influenza Vaccine
Time frame: Baseline to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A Fluzone® (IM) | Number of Participants From Each Arm Who Received Influenza Vaccine | 42 Participants |
| Group B Fluzone® (ID) | Number of Participants From Each Arm Who Received Influenza Vaccine | 19 Participants |
| Group C Flumist® | Number of Participants From Each Arm Who Received Influenza Vaccine | 25 Participants |
Secondary
Number of Participants With Related Adverse Events
Number of participants with Related Adverse Events with a 0% Frequency Threshold
Time frame: Baseline to Day 28
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A Fluzone® (IM) | Number of Participants With Related Adverse Events | No Related Adverse Events | 40 Participants |
| Group A Fluzone® (IM) | Number of Participants With Related Adverse Events | Erythema at injection site | 1 Participants |
| Group A Fluzone® (IM) | Number of Participants With Related Adverse Events | Bronchospasm | 1 Participants |
| Group B Fluzone® (ID) | Number of Participants With Related Adverse Events | No Related Adverse Events | 19 Participants |
| Group B Fluzone® (ID) | Number of Participants With Related Adverse Events | Bronchospasm | 0 Participants |
| Group B Fluzone® (ID) | Number of Participants With Related Adverse Events | Erythema at injection site | 0 Participants |
| Group C Flumist® | Number of Participants With Related Adverse Events | Erythema at injection site | 0 Participants |
| Group C Flumist® | Number of Participants With Related Adverse Events | Bronchospasm | 0 Participants |
| Group C Flumist® | Number of Participants With Related Adverse Events | No Related Adverse Events | 25 Participants |
Other Pre-specified
Frequency of Vaccine-specific Antibody Secreting Cells on Day 5 and Day 7 After Vaccination
Time frame: Baseline to Day 7