Advertisement

Topics

FLUAD vs. Fluzone High-Dose Study

2017-06-14 00:56:54 | BioPortfolio

Summary

The overall aim of the study is to compare safety and immunogenicity of adjuvanted inactivated influenza vaccine (IIV) (FLUAD) versus High-Dose inactivated influenza (Fluzone High Dose) vaccine in ≥65 years (20% aged ≥80 years). A prospective, randomized, blinded clinical trial that will be conducted during the 2017/2018 and 2018/2019 influenza seasons. During each season, approximately 220 older adults will be enrolled at Duke University Medical Center and 140 older adults at Boston University Medical Center. Eligible subjects will be randomized to receive either adjuvanted influenza vaccine or High-Dose influenza vaccine. All subjects will receive vaccine and provide a blood draw at Visit 1, and then return for a second blood draw without vaccination about 4 weeks later to assess for influenza antibody titers. A subset of 100 subjects at Duke will provide a third blood draw 6 months post-vaccination to assess for waning of influenza antibody titers. Subjects will record the occurrence of local and systemic reactions (including fever, pain, tenderness, swelling, redness, general systemic systems), unsolicited adverse events, medical care utilization, and changes in medications over 8 days following vaccination. In addition, serious adverse events and events of clinical interest will be assessed through 42 days post-vaccination. Quality of life will be assessed 8 days post-vaccination and vaccine perceptions surveys will be administered 8 days and 4 weeks post-vaccination.

Study Design

Conditions

Pain

Intervention

FLUAD, Fluzone High-Dose

Location

Centers for Disease Control and Prevention
Atlanta
Georgia
United States
30333

Status

Not yet recruiting

Source

Duke University

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-06-14T00:56:54-0400

Clinical Trials [1641 Associated Clinical Trials listed on BioPortfolio]

Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults

The purpose of this study is to determine whether Fluzone High Dose increases the immune response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone in im...

Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults

The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 y...

Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines

This multicenter, open-label, Phase IV study was designed to describe the safety and immunogenicity of Fluzone Quadrivalent vaccine in children 6 months to < 9 years of age and adults 18 t...

Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly

Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at high...

Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older

The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly. Primary objective: To measure the efficacy of the vacc...

PubMed Articles [19489 Associated PubMed Articles listed on BioPortfolio]

The relationship of dose to nerve volume in predicting pain recurrence after stereotactic radiosurgery in trigeminal neuralgia.

OBJECTIVE Approximately 75%-92% of patients with trigeminal neuralgia (TN) achieve pain relief after Gamma Knife surgery (GKS), although a proportion of these patients will experience recurrence of th...

Intraoperative naloxone reduces remifentanil-induced postoperative hyperalgesia but not pain: a randomized controlled trial.

Intraoperative use of a high-dose remifentanil may induce postoperative hyperalgesia. Low-dose naloxone can selectively reverse some adverse effects of opioids without compromising analgesia. We thus ...

OPRM1 Methylation Contributes to Opioid Tolerance in Cancer Patients.

Cancer patients in pain require high doses of opioids and quickly become opioid-tolerant. Previous studies have shown that both chronic cancer pain and high dose opioid use lead to mu-opioid receptor ...

High-dose radiotherapy is associated with better local control of bone metastasis from hepatocellular carcinoma.

We evaluated the pain and radiologic response, time to progression, and dose-response relationship after palliative radiotherapy for bone metastasis from hepatocellular carcinoma. We retrospectively r...

Low-Dose Intravenous Immunoglobulin Treatment for Long-Standing Complex Regional Pain Syndrome: A Randomized Trial.

Two small trials suggest that low-dose intravenous immunoglobulin (IVIg) may improve the symptoms of complex regional pain syndrome (CRPS), a rare posttraumatic pain condition.

Medical and Biotech [MESH] Definitions

The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.

Mice selectively bred for hypersusceptibility to two-stage chemical skin carcinogenesis. They are also hypersusceptible to UV radiation tumorigenesis with single high-dose, but not chronic low-dose, exposures. SENCAR (SENsitive to CARcinogenesis) mice are used in research as an animal model for tumor production.

The specific failure of a normally responsive individual to make an immune response to a known antigen. It results from previous contact with the antigen by an immunologically immature individual (fetus or neonate) or by an adult exposed to extreme high-dose or low-dose antigen, or by exposure to radiation, antimetabolites, antilymphocytic serum, etc.

A treatment schedule in which the total dose of radiation is divided into large doses.

Relief of PAIN, without loss of CONSCIOUSNESS, through ANALGESIC AGENTS administered by the patients. It has been used successfully to control POSTOPERATIVE PAIN, during OBSTETRIC LABOR, after BURNS, and in TERMINAL CARE. The choice of agent, dose, and lockout interval greatly influence effectiveness. The potential for overdose can be minimized by combining small bolus doses with a mandatory interval between successive doses (lockout interval).

More From BioPortfolio on "FLUAD vs. Fluzone High-Dose Study"

Quick Search
Advertisement