A Phase 4 interventional study of TIV and High-Dose TIV in Influenza, sponsored by Stanford University. Completed. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-22.
Sponsored by Stanford University · Phase 4, Interventional, and Basic science
This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.
The investigators plan to study the response to different influenza vaccines much more broadly and deeply across different age groups and with different vaccine modalities and to probe the influence of genetics on these responses using monozygotic and dizygotic twins. On an investigational basis, the investigators plan to compare various immunological responses, identify age-specific biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of T-cell repertoire to an influenza vaccine within an individual as a function of age and to what degree this is genetically determined.
Twin group B will will be randomly assigned to receive a single dose of inactivated vaccine, either the trivalent inactivated influenza vaccine (TIV) or intranasal live, attenuated influenza vaccine (LAIV). Twin Groups C-E will receive a single administration of TIV. Group F, elderly participants, will be randomly assigned to receive a single dose of inactivated vaccine, either the standard dose or the high-dose TIV. Blood samples to conduct the assays described will be taken at pre-immunization, Days 7-10 and 28 post-immunization.
Groups A, C and E were not enrolled for this year of the five year annual study.
2,215 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 22 is below the median of 239 across 1,854 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:
Participants to receive FluMist® LAIV by nasal spray.
Biological: LAIV
Participants to receive Fluzone® standard TIV
Biological: TIV
Participants to receive Fluzone® standard TIV
Biological: TIV
Participants to receive Fluzone® standard TIV
Biological: TIV
Participants to receive High-Dose Fluzone® standard TIV
Biological: High-Dose TIV
Influenza Virus Vaccine Suspension for Intramuscular Injection
Also known as: Fluzone® standard TIV
High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe
Also known as: High-Dose Fluzone® TIV
Live, attenuated influenza vaccine for Intranasal Spray
Also known as: FluMist®
Number of Participants Who Received Influenza Vaccine
Time frame: Day 0
Number of Participants With Related Adverse Events
Time frame: Day 0 to 28 post-immunization
Numbers listed in the tables reflect individual twins and not twin pairs.
| Milestone | Group B: 18-30 yo Identical Twins (LAIV) | Group B: 18-30 yo Identical Twins (TIV) | Group D: 40 - 64 yo Identical Twins | Group F: 65-100 yo Identical Twins (TIV) | Group F: 65-100 yo Identical Twins (High-Dose TIV) |
|---|---|---|---|---|---|
| Started | 5 | 5 | 6 | 3 | 3 |
| Completed | 5 | 5 | 6 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Participants | Group B: 18-30 yo Identical Twins (LAIV) | Group B: 18-30 yo Identical Twins (TIV) | Group D: 40 - 64 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (High-Dose TIV) |
|---|---|---|---|---|---|
| Number of Participants Who Received Influenza Vaccine | 5 | 5 | 6 | 3 | 3 |
| Participants | Group B: 18-30 yo Identical Twins (LAIV) | Group B: 18-30 yo Identical Twins (TIV) | Group D: 40 - 64 yo Identical Twins | Group F: 65 - 100 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (High Dose TIV) |
|---|---|---|---|---|---|
| Number of Participants With Related Adverse Events | 0 | 0 | 0 | 0 | 0 |
Collected over Day 0 to 28 of study participation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group B: 18-30 yo Identical Twins (LAIV) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Group B: 18-30 yo Identical Twins (TIV) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Group D: 40 - 64 yo Identical Twins (TIV) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Group F: 65 - 100 yo Identical Twins (TIV) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Group F: 65 - 100 yo Identical Twins (High-Dose TIV) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Continuous(years) | Group B: 18-30 yo Identical Twins (LAIV) | Group B: 18-30 yo Identical Twins (TIV) | Group D: 40 - 64 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (High-Dose TIV) | Total |
|---|---|---|---|---|---|---|
| Mean | 22.98 ± 4.26 | 22.98 ± 4.26 | 42.76 ± 1.93 | 73.45 ± 4.20 | 73.45 ± 4.20 | 42.14 ± 21.63 |
| Sex: Female, Male(Participants) | Group B: 18-30 yo Identical Twins (LAIV) | Group B: 18-30 yo Identical Twins (TIV) | Group D: 40 - 64 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (High-Dose TIV) | Total |
|---|---|---|---|---|---|---|
| Female | 4 | 4 | 4 | 2 | 2 | 16 |
| Male | 1 | 1 | 2 | 1 | 1 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Group B: 18-30 yo Identical Twins (LAIV) | Group B: 18-30 yo Identical Twins (TIV) | Group D: 40 - 64 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (High-Dose TIV) | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 0 | 0 | 0 | 6 |
| Not Hispanic or Latino | 2 | 2 | 6 | 3 | 3 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group B: 18-30 yo Identical Twins (LAIV) | Group B: 18-30 yo Identical Twins (TIV) | Group D: 40 - 64 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (High-Dose TIV) | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 0 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 0 | 0 | 0 | 2 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 2 | 2 | 6 | 3 | 3 | 16 |
| More than one race | 1 | 1 | 0 | 0 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Group B: 18-30 yo Identical Twins (LAIV) | Group B: 18-30 yo Identical Twins (TIV) | Group D: 40 - 64 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (TIV) | Group F: 65 - 100 yo Identical Twins (High-Dose TIV) | Total |
|---|---|---|---|---|---|---|
| United States | 5 | 5 | 6 | 3 | 3 | 22 |
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Plan to share: No
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