Immune Response to High-Dose vs. Standard Dose Influenza Vaccine

Phase 4

• Conditions: Elderly Immune System
• Interventions: Biological: Flu Vaccine

• Registration Number: NCT02297542
• Lead Sponsor: Health Sciences North Research Institute

Brief Summary

This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-21
• Status Verified: 2018-02
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. Written informed consent provided by the participant

2. Age 20-40 years old with no underlying chronic diseases or age ≥65 years old

3. Willing to receive influenza vaccination

4. Older cohort has received their influenza vaccine for the previous influenza season

Exclusion Criteria

1. Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily)

2. Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination

3. Participant has received a community available influenza vaccine for the approaching influenza season

4. Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Flu Vaccine HD	Flu Vaccine	Fluzone High Dose Influenza Vaccine
Flu Vaccine SD	Flu Vaccine	Fluzone Standard Dose Influenza Vaccine

Primary Outcome Measures

Name	Time	Method
Number of Influenza Cases	five years	Influenza surveillance includes weekly contact with study subjects to assess for any flu-like symptoms or acute respiratory infection (ARI), and include nasopharyngeal swabs (within 5 days of onset of symptoms) for polymerase chain reaction (PCR) detection of influenza virus and post-influenza season detection of an antibody response to influenza infection. Routine screen for symptoms of ARI will also occur at the 4, 10 and 20 week visits when blood samples are collected. Influenza illness will be documented by PCR detection of influenza during an IARI or seroconversion (4-fold rise in antibody titers) in association with an ARI. ARI includes upper (coryza or sore throat) or lower (cough or shortness of breath) respiratory tract symptoms, or headache, malaise, myalgia or fever (\> 99°F or 37.3°C orally or 100°F rectally) \[41\]. as physician visits, hospitalizations and deaths attributed to acute cardiopulmonary illness and will be tracked through the influenza season.

Trial Locations

Locations (2)

Health Sciences North Research Institute; 🇨🇦 Sudbury, Ontario, Canada

Center on Aging, UConn Health; 🇺🇸 Farmington, Connecticut, United States