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Open-Label Influenza Vaccine Evaluation

NCT02872311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2025-12-10

Study results available
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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.

Conditions

  • Immune Response

Interventions

BIOLOGICAL

High Dose Influenza vaccine

Licensed and FDA approved Fluzone HD vaccine to be administered to study participants

BIOLOGICAL

Adjuvanted Influenza vaccine

Licensed and FDA approved FluAd vaccine to be administered to study participants

BIOLOGICAL

Standard Dose Influenza vaccine

Licensed and FDA approved Fluvirin vaccine to be administered to study participants

BIOLOGICAL

Recombinant Influenza vaccine

Licensed and FDA approved FluBlok vaccine to be administered to study participants

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-04-30
Completion
2018-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02872311 on ClinicalTrials.gov