N/A
N=179
Open-Label Influenza Vaccine Evaluation
Immune Response
Bottom Line
View on ClinicalTrials.gov: NCT02872311 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination — 175; 117; 144; 118 Titer
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Dose Influenza vaccine (Biological); Adjuvanted Influenza vaccine (Biological); Standard Dose Influenza vaccine (Biological); Recombinant Influenza vaccine (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Marshfield Clinic Research Foundation
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination |
175; 117; 144; 118; 166; 81 | — |
| PRIMARY HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination |
83; 56; 83; 68; 61; 44 | — |
| PRIMARY HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination |
54; 44; 75; 75; 36; 24 | — |
| PRIMARY HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination |
83; 101; 158; 158; 63; 45 | — |
| PRIMARY HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination |
46; 44; 101; 124; 44; 30 | — |
| SECONDARY HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination |
116; 136; 122; 343; 105; 128 | — |
| SECONDARY HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination |
59; 67; 48; 146; 68; 84 | — |
| SECONDARY HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination |
51; 48; 26; 73; 82; 79 | — |
| SECONDARY MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination |
256; 246; 57; 69; 47; 52 | — |
| SECONDARY MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination |
138; 132; 44; 42; 29; 30 | — |
| SECONDARY MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination |
138; 132; 45; 55; 29; 30 | — |
| SECONDARY MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination |
73; 95 | — |
| SECONDARY HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination |
44; 86; 126; 126; 163; 174 | — |
| SECONDARY HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination |
26; 33; 75; 95; 122; 135 | — |
| SECONDARY HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination |
101; 83; 44; 86; 158; 158 | — |
| SECONDARY HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination |
44; 46; 26; 33; 124; 101 | — |
| SECONDARY Number of Participants With Vaccine Failure, Year 1 |
4; 3; 1; 0; 1; 1 | — |
| SECONDARY Number of Participants With Vaccine Failure, Year 2 |
3; 6; 1; 2; 3; 4 | — |
Summary
This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the immune response to consecutive influenza vaccination across 2 seasons. Participants will be randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will receive the same vaccination in the second year and the third arm will be randomized again to 1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood draws for a total of 6 draws over 18 months.
Eligibility Criteria
Inclusion Criteria
- Age 65-74 years at the time of study enrollment and are ambulatory and live in selected Wisconsin community or surrounding communities.
- Willing and able to give informed consent prior to study enrollment
- Able to comply with study requirements.
Exclusion Criteria
- Prior receipt of 2016-17 influenza vaccine
- Current participation in another clinical trial
- Presence of a contraindication to influenza vaccine
Data sourced from ClinicalTrials.gov (NCT02872311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.