Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients

NCT01512056 | Unknown Phase 4

• 1 other identifier: BR-100-086
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012).

Conditions

Influenza

Keywords

Influenza vaccine; dialysis; vaccine; Seroprotection; Seroresponse; Seroconversion; Safety of the vaccine

Outcome Measures

Primary Outcomes (1)

• Change of antibody titer before and after influenza vaccination

  The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay will also be used to evaluate the immune response post vaccination. The immune response based on microNT-ELISA antibody titers would be reported as antibody titer ≥1: 40 or ≥ 1:160 respectively because no threshold of protective NT antibody titer is clearly defined by the international guidelines.

  18 weeks

Secondary Outcomes (3)

• Seroresponse rate

  0, 3 weeks, 6 weeks, 9 weeks and 18 weeks

• Seroresponse rate

  0, 3 weeks, 6 weeks, 9 weeks and 18 weeks

• the safety and tolerability profiles of the vaccine

  0, 3 week, 6 weeks, 9 weeks, 18 weeks

Study Arms (2)

the immunogenicity profiles of the AdimFlu-S

EXPERIMENTAL

Experimental group: to receive either only one dose of influenza vaccine at day 0 or one more booster vaccination 3 weeks later. Negative control group: dialysis patients who refused to receive influenza vaccination.

Drug: AdimFlu-S

The safety outcome of the vaccine

NO INTERVENTION

Any adverse effect, including systemic or local site, will be recorded during the study period.

Interventions

AdimFlu-S DRUG

All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). Each dose of vaccine contains 15μg antigen of each virus strain suggested by WHO (A/California/7/2009 (H1N1);A/Perth/16/2009 (H3N2);B/Brisbane/60/2008).

the immunogenicity profiles of the AdimFlu-S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant females and aged more than 18 years;
• Willing and able to adhere to visit schedules and all study requirements;
• Subjects read and signed the study-specific informed consent.

You may not qualify if:

• Subject or his/her family is employed by the participated hospital;
• Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
• History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
• Personal or family history of Guillain-Barré Syndrome;
• An acute febrile illness within 1 week prior to vaccination;
• Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
• Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
• Female subjects who are pregnant during the study.
• Patients who receive hemodialysis therapy less than 3 months.
• Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
• Immunodeficiency, or under immunosuppressive treatment.
• Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
• Receipt of any blood products, including immunoglobulin in the prior 3 months;
• Any severe illness needed to be hospitalization within three months.
• Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Influenza, Human; HIV Seropositivity

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Junne Ming Sung, MD

CONTACT

886-6-2353535; jmsung@mail.ncku.edu.tw

Yu Tzu Chang, MD and Msc

CONTACT

886-6-2353535; kangxiemperor@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: January 19, 2012
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

TW (1)