Influenza
Conditions
Keywords
Trivalent inactivated influenza vaccine, Young children, Young adults
Brief summary
In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different vaccines given to identical twins and vaccine-naive young adults.
Detailed description
This is a study of healthy children and adults who will be given standard seasonal influenza vaccination (IIV3). There are no exclusions for gender, ethnicity or race. Following review and confirmation of written informed consent, volunteers will be enrolled into the study. The 1-2 year-old child volunteers enrolled in Group A cannot have been previously immunized with an influenza vaccine. They will receive two single doses of the 2013-2014 pediatric formulation of seasonal trivalent inactivated influenza vaccine (IIV3), at least 28 days apart, given by intramuscular (IM) injection. The child volunteers will complete 4 clinic visits with 3 blood sample collections. Study visits will be on Day 0 (first immunization), Day 28-32 (second immunization), Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. The baseline blood sample will be drawn prior to immunization at Day 0, followed by two additional blood samples at Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. There will not be a blood sample collected at Day 28-32. The 18-30 year-old young adults in Group B cannot have been immunized with the 2012-2013 seasonal influenza vaccine. Participants in Group B will receive a single dose of the 2013-2014 IIV3 by IM injection. Young adult volunteers will complete 3 clinic visits with 3 blood sample collections on Day 0, Day 6-8, and Day 28+4. The baseline blood sample will be drawn prior to immunization at Day 0.
Interventions
BIOLOGICALFluzone
Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, ambulatory children 1-2 years of age or 18-30 year-old young adults. 2. Willing to complete the informed consent process. 3. Availability for follow-up for the planned duration of the study (after last study immunization, approximately 8 weeks for Group A and 4 weeks for Group B). 4. Acceptable medical history by medical history and vital signs.
Exclusion criteria
1. Group A: Prior vaccination with a seasonal flu vaccine (IIV). Group B: Prior vaccination with the 2012-2013 seasonal flu vaccine (IIV or LAIV). 2. Prior off-study vaccination with the current 2013-2014 seasonal IIV or LAIV 3. Allergy to egg or egg products, or to vaccine components. 4. Life-threatening reactions to previous influenza vaccinations 5. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination 6. History of immunodeficiency (including HIV infection) 7. 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. 8. Chronic Hepatitis B or C. 9. Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible; use of inhaled steroids, or oral steroids (\<20mg prednisone-equivalent/day), may be acceptable after review by the investigator. 10. 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). 11. 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. 12. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year 13. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety. 14. Receipt of blood or blood products within the past 6 months 15. Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol 16. Inactivated vaccine within 14 days prior to study vaccination (inform study staff of any non-study vaccinations received during study period) 17. Live, attenuated vaccine within 30 days prior to first study vaccination, or planned immunization with a live, attenuated vaccine before completion of study visits (inform study staff of any non-study vaccinations received during study period). 18. Need for allergy immunizations (that cannot be rescheduled if necessary) during the study period 19. History of Guillain-Barre Syndrome 20. Pregnant or lactating woman 21. Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits 22. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment 23. 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 Who Received Influenza Vaccine | Day 0 to 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Related Adverse Events | Day 0 to 28 post-immunization |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A: 1 - 2 Years Old Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula. | 1 |
| Group B: 18-30 Years Old Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula. | 7 |
| Total | 8 |
Baseline characteristics
| Characteristic | Group A: 1 - 2 Years Old | Total | Group B: 18-30 Years Old |
|---|---|---|---|
| Age, Continuous | 1.128 years STANDARD_DEVIATION 0 | 24.025 years STANDARD_DEVIATION 9.98 | 27.29 years STANDARD_DEVIATION 4.066 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 6 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 1 participants | 8 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 7 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 1 / 7 |
| serious Total, serious adverse events | 0 / 1 | 0 / 7 |
Outcome results
Primary
Number of Participants Who Received Influenza Vaccine
Time frame: Day 0 to 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: 1 - 2 Years Old | Number of Participants Who Received Influenza Vaccine | 1 Participants |
| Group B: 18-30 Years Old | Number of Participants Who Received Influenza Vaccine | 7 Participants |
Secondary
Number of Participants With Related Adverse Events
Time frame: Day 0 to 28 post-immunization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: 1 - 2 Years Old | Number of Participants With Related Adverse Events | 1 Participants |
| Group B: 18-30 Years Old | Number of Participants With Related Adverse Events | 1 Participants |