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

Influenza Clinical Trial

Official title:

Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2011-2012, in Non-Elderly Adult and Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411358
• Other study ID #: FLU11T12A
• Status: Completed
• Phase: N/A
• First received: August 5, 2011
• Last updated: July 10, 2012
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2012
• Source: Adimmune Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• non-elderly aged between 18 and 60
one dose of 0.5mL AdimFlu-S
• elderly aged over 60
one dose of 0.5mL AdimFlu-S

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Adimmune Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No