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Vaccine

Blood draw- adjuvanted TIV for Influenza

N/A
Waitlist Available
Research Sponsored by Insight Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Resident of Medicare Certified Facility (so they have to report Minimum Data Set (MDS) data)
Residence in a long-term care facility administering a Seqirus influenza vaccine as the standard-of-care.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 and day 28 +/-3 days
Awards & highlights

Study Summary

The study is designed to evaluated if adjuvanted vaccine elicits higher T cell and B cell responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.

Eligible Conditions
  • Influenza

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 and day 28 +/-3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 and day 28 +/-3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in hemagglutination inhibition (HAI)
Change in microneutralization (MN)
Secondary outcome measures
Change in cell mediated immunity (CMI) - IFN-gamma
Change in cell mediated immunity (CMI) - IL-10

Side effects data

From 2017 Phase 2 trial • 14 Patients • NCT01437488
64%
Fatigue
43%
Diarrhea
36%
Constipation
36%
Anemia
36%
Nausea
21%
Creatinine Increased
21%
Lightheadedness
21%
Vomiting
21%
Hypokalemia
14%
Abdominal Pain
14%
Back Pain
14%
Dizziness
14%
Fever
14%
Flu-Like symptoms
14%
Hypomagnesia
14%
Pinching sensation around port
14%
Shortness of Breath
14%
URI
14%
Abdominal cramping
14%
Insomnia
14%
Thrombocytopenia
7%
Decreased Appetite
7%
Bloating
7%
Sacral Edema
7%
Dry Skin
7%
Tearing
7%
Tinnitus
7%
Acid Reflux
7%
INR increased
7%
Embolic stroke
7%
Pulmonary Embolism
7%
Anorexia
7%
Anxiety
7%
Dyspnea
7%
Dysuria
7%
Fall
7%
Flatulence
7%
Foot Pain
7%
Hematoma
7%
Leg pain
7%
Loose Stools
7%
mild-mod Congestion
7%
Neutrophil count decreased
7%
Neuropathy
7%
Rib pain
7%
Throat discomfort
7%
Urinary incontinence
7%
Urinary Tract Obstruction
7%
Worsening pain
7%
Vision changes
7%
Blood in Bilirubin increased
7%
Hypoxia
7%
Abdominal distention
7%
Alkalosis
7%
Bladder Spasm
7%
Blurred Vision
7%
Bone Pain
7%
Cabazitaxel Infusion reaction
7%
Change in Taste
7%
Epigastric Pain
7%
Hematuria
7%
Hypophosphatemia
7%
Hypertension
7%
Pain in Pelvis
7%
Paresthesia bilateral feet
7%
Perioral numbness
7%
Peripheral Neuropathy
7%
Weakness
7%
Weight loss
7%
Tachycardia
7%
Bleeding Gums
7%
PTT prolonged
7%
Pyelonephritis
7%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabazitaxel

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Blood draw- adjuvanted TIVExperimental Treatment1 Intervention
individuals who received adjuvanted trivalent influenza vaccine (aTIV, Fluad) and consent to a blood draw
Group II: Blood draw - nonadjuvanted TIVActive Control1 Intervention
individuals who received nonadjuvanted trivalent influenza vaccine and consent to a blood draw
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Draw
2006
Completed Phase 4
~2400

Find a Location

Who is running the clinical trial?

SeqirusIndustry Sponsor
59 Previous Clinical Trials
1,080,870 Total Patients Enrolled
Insight Therapeutics, LLCLead Sponsor
8 Previous Clinical Trials
32,007 Total Patients Enrolled
Case Western Reserve UniversityOTHER
298 Previous Clinical Trials
259,813 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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~24 spots leftby Mar 2025