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OpenTrials
Completed

NCT Number: NCT01411358

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-elderly aged between 18 and 60

Biological

one dose of 0.5mL AdimFlu-S

elderly aged over 60

Biological

one dose of 0.5mL AdimFlu-S

Primary outcomes

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

    Time frame: 3 weeks post vaccination

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

Sponsors and collaborators

Lead sponsor

Adimmune Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 8, 2011
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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