A Phase 4 interventional study of Trivalent, inactivated influenza vaccine (TIV) and Quadrivalent, inactivated influenza vaccine (IIV4) in Influenza, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by Stanford University · Phase 4, Interventional, and Prevention
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.
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 In 2008, 2012 and 2014, the cohort added additional participants to replace those who had withdrawn.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.
2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 136 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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) · Biological: Quadrivalent, inactivated influenza vaccine (IIV4)
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) · Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
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) · Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
Licensed Seasonal Influenza Vaccine TIV
Also known as: Fluzone (IM)
Licensed Seasonal Influenza Vaccine IIV4
Also known as: Fluzone (IM)
Licensed Seasonal High-Dose Influenza Vaccine TIV
Also known as: Fluzone High-Dose (IM)
Number of Participants Who Received the Influenza Vaccine
Time frame: Day 0 annually while on study
Number of Participants With Related Adverse Events
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
Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 5-7 for T Cells and Antibody-secreting Cells (ASCs)
Time frame: Day 0 to 7
Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 28-32 for Responses to the Vaccine Antigens
Time frame: Day 0-Day28
| Milestone | 18-30 Years Old at Enrollment | 60-79 Years Old at Enrollment | 80-100 Years Old at Enrollment |
|---|---|---|---|
| Started | 59 | 37 | 40 |
| Completed | 18 | 19 | 12 |
| Not completed | 41 | 18 | 28 |
| Participants | 18-30 Years Old at Enrollment | 60-79 Years Old at Enrollment | 80-100 Years Old at Enrollment |
|---|---|---|---|
| Number of Participants Who Received the Influenza Vaccine | 59 | 37 | 40 |
Related adverse events were recorded annually during this 10 year longitudinal study.
| Participants | 18-30 Years Old at Enrollment | 60-79 Years Old at Enrollment | 80-100 Years Old at Enrollment |
|---|---|---|---|
| Erythema at injection site | 0 | 0 | 1 |
| Rash at injection site | 0 | 0 | 1 |
| Pain at injection site | 1 | 0 | 0 |
| Flushing | 0 | 1 | 0 |
| High White Blood Cell Count | 0 | 1 | 0 |
| Lymphopenia | 0 | 0 | 1 |
| Thrombocytopenia | 1 | 0 | 0 |
| No Related Adverse Events | 57 | 35 | 37 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 18-30 Years Old at Enrollment | 0/59 (0%) | 2/59 (3.4%) | 31/59 (52.5%) |
| 60-79 Years Old at Enrollment | 2/37 (5.4%) | 20/37 (54.1%) | 29/37 (78.4%) |
| 80-100 Years Old at Enrollment | 16/40 (40%) | 34/40 (85%) | 21/40 (52.5%) |
| Event | 18-30 Years Old at Enrollment | 60-79 Years Old at Enrollment | 80-100 Years Old at Enrollment |
|---|---|---|---|
| Hip ArthroplastySurgical and medical procedures | 0/59 | 2/37 | 7/40 |
| Congestive Heart FailureCardiac disorders | 0/59 | 1/37 | 6/40 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/59 | 1/37 | 5/40 |
| Myocardial InfarctionCardiac disorders | 0/59 | 0/37 | 3/40 |
| DeathCardiac disorders | 0/59 | 0/37 | 3/40 |
| Fractures/AccidentsMusculoskeletal and connective tissue disorders | 0/59 | 1/37 | 3/40 |
| UTIRenal and urinary disorders | 0/59 | 0/37 | 3/40 |
| StrokeVascular disorders | 0/59 | 2/37 | 3/40 |
| Atrial FibrillationCardiac disorders | 0/59 | 2/37 | 2/40 |
| UlcerGastrointestinal disorders | 0/59 | 2/37 | 1/40 |
| Event | 18-30 Years Old at Enrollment | 60-79 Years Old at Enrollment | 80-100 Years Old at Enrollment |
|---|---|---|---|
| Upper respiratory infectionInfections and infestations | 14/59 | 15/37 | 5/40 |
| Influenza Type IllnessRespiratory, thoracic and mediastinal disorders | 7/59 | 2/37 | 0/40 |
| RhinitisRespiratory, thoracic and mediastinal disorders | 7/59 | 1/37 | 1/40 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/59 | 1/37 | 4/40 |
| AnemiaBlood and lymphatic system disorders | 0/59 | 2/37 | 4/40 |
| Lower Back PainMusculoskeletal and connective tissue disorders | 1/59 | 3/37 | 3/40 |
| DiarrheaGastrointestinal disorders | 0/59 | 3/37 | 1/40 |
| Urinary Tract InfectionInfections and infestations | 2/59 | 2/37 | 3/40 |
| Age, Continuous(years) | 18-30 Years Old at Enrollment | 60-79 Years Old at Enrollment | 80-100 Years Old at Enrollment | Total |
|---|---|---|---|---|
| Mean | 29.6 ± 2.9 | 73.3 ± 5.0 | 89.5 ± 4.3 | 70.9 ± 23.1 |
| Sex: Female, Male(Participants) | 18-30 Years Old at Enrollment | 60-79 Years Old at Enrollment | 80-100 Years Old at Enrollment | Total |
|---|---|---|---|---|
| Female | 30 | 22 | 26 | 78 |
| Male | 29 | 15 | 14 | 58 |
| Ethnicity (NIH/OMB)(Participants) | 18-30 Years Old at Enrollment | 60-79 Years Old at Enrollment | 80-100 Years Old at Enrollment | Total |
|---|---|---|---|---|
| Hispanic or Latino | 6 | 0 | 0 | 6 |
| Not Hispanic or Latino | 53 | 37 | 40 | 130 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 18-30 Years Old at Enrollment | 60-79 Years Old at Enrollment | 80-100 Years Old at Enrollment | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 12 | 0 | 1 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 37 | 37 | 37 | 111 |
| More than one race | 8 | 0 | 2 | 10 |
| Unknown or Not Reported | 2 | 0 | 0 | 2 |
| Region of Enrollment(participants) | 18-30 Years Old at Enrollment | 60-79 Years Old at Enrollment | 80-100 Years Old at Enrollment | Total |
|---|---|---|---|---|
| United States | 59 | 37 | 40 | 136 |
Plan to share: Yes — The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique ID code and the volunteer identity (except for age) will not be disclosed.
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