A Phase 4 interventional study of Fluzone and FluMist in Influenza, sponsored by Stanford University. Completed. Open to participants aged 8 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by Stanford University · Phase 4, Interventional, and Basic science
In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different influenza vaccines given to identical twins, vaccine-naive young adults and elderly participants.
This is an exploratory study of healthy children and adults who are given either standard trivalent, inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV). There are no exclusions for gender, ethnicity or race. Following confirmation of written informed consent, baseline blood samples will be drawn from all study participants prior to immunization. The volunteers enrolled in any the three groups (A,B,C) cannot have been immunized with previous year's seasonal influenza vaccine. The identical twins in Groups A will be randomized to each receive a different vaccine (TIV or LAIV) than their twin. The non-twin children in Group B will also be randomly assigned to receive either TIV or LAIV. Non-twin elderly adults in Group C will be given standard TIV. All participants will receive a single dose of their assigned influenza vaccine, either by intramuscular (IM) injection (TIV) or intranasal application (LAIV).
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 91 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:
Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
Biological: Fluzone · Biological: FluMist
Group B: 8-30 years old non-twin individuals randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
Biological: Fluzone · Biological: FluMist
Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
Biological: Fluzone
Influenza Virus Vaccine Suspension for Intramuscular Injection
Influenza Virus Vaccine Live, Intranasal Intranasal Spray
Number of Participants Who Received Influenza Vaccine
Time frame: Day 0 to 28
Number of Participants With Related Adverse Events
Time frame: Day 0 to 28 post-immunization
Investigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses.
Time frame: Day 0 to 28
| Milestone | Group A: 8-17 yo Identical Twins | Group B: 8-30 yo Non-twin | Group C: 70-100 yo Non-twin |
|---|---|---|---|
| Started | 14 | 41 | 36 |
| Completed | 14 | 38 | 36 |
| Not completed | 0 | 3 | 0 |
| Participants | Group A: 8-17 yo Identical Twins | Group B: 8-30 yo Non-twin | Group C: 70-100 yo Non-twin |
|---|---|---|---|
| Number of Participants Who Received Influenza Vaccine | 14 | 38 | 36 |
| Participants | Group A: 8-17 yo Identical Twins | Group B: 8-30 yo Non-twin | Group C: 70-100 yo Non-twin |
|---|---|---|---|
| Number of Participants With Related Adverse Events | 1 | 1 | 1 |
Results for this outcome have not been posted.
Collected over Day 0 to Day 28 of study participation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: 8-17 yo Identical Twins | — | 0/14 (0%) | 1/14 (7.1%) |
| Group B: 8-30 yo Non-twin | — | 0/38 (0%) | 1/38 (2.6%) |
| Group C: 70-100 yo Non-twin | — | 0/36 (0%) | 1/36 (2.8%) |
| Event | Group A: 8-17 yo Identical Twins | Group B: 8-30 yo Non-twin | Group C: 70-100 yo Non-twin |
|---|---|---|---|
| SyncopeNervous system disorders | 1/14 | 0/38 | 0/36 |
| Light headednessNervous system disorders | 0/14 | 1/38 | 1/36 |
| Age, Continuous(years) | Group A: 8-17 yo Identical Twins | Group B: 8-30 yo Non-twin | Group C: 70-100 yo Non-twin | Total |
|---|---|---|---|---|
| Mean | 12.84 ± 3.53 | 21.82 ± 5.32 | 77.00 ± 5.313 | 42.27 ± 28.86 |
| Sex: Female, Male(Participants) | Group A: 8-17 yo Identical Twins | Group B: 8-30 yo Non-twin | Group C: 70-100 yo Non-twin | Total |
|---|---|---|---|---|
| Female | 10 | 23 | 21 | 54 |
| Male | 4 | 18 | 15 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Group A: 8-17 yo Identical Twins | Group B: 8-30 yo Non-twin | Group C: 70-100 yo Non-twin | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 5 | 0 | 7 |
| Not Hispanic or Latino | 12 | 36 | 36 | 84 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group A: 8-17 yo Identical Twins | Group B: 8-30 yo Non-twin | Group C: 70-100 yo Non-twin | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 13 | 0 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 0 | 2 |
| White | 12 | 22 | 36 | 70 |
| More than one race | 2 | 2 | 0 | 4 |
| Unknown or Not Reported | 0 | 2 | 0 | 2 |
| Region of Enrollment(participants) | Group A: 8-17 yo Identical Twins | Group B: 8-30 yo Non-twin | Group C: 70-100 yo Non-twin | Total |
|---|---|---|---|---|
| United States | 14 | 41 | 36 | 91 |
No study locations are listed for this record.
Plan to share: No
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