Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects

NCT01411358 | Completed

• 1 other identifier: FLU11T12A
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Conditions

Influenza

Keywords

influenza; vaccine; immunogenicity

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 40.

  Serum samples will be tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI).

  3 weeks post vaccination

Study Arms (1)

AdimFlu-S 2011-2012

EXPERIMENTAL

Biological: non-elderly aged between 18 and 60; Biological: elderly aged over 60

Interventions

non-elderly aged between 18 and 60 BIOLOGICAL

one dose of 0.5mL AdimFlu-S

AdimFlu-S 2011-2012

elderly aged over 60 BIOLOGICAL

one dose of 0.5mL AdimFlu-S

AdimFlu-S 2011-2012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or non-pregnant females and aged ≥ 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
• 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;
• Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine

Sponsors & Collaborators

• Adimmune Corporation: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Gin-Hsiang Wu, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 8, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

TW (1)