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CompletedNCT01411358Updated Jul 12, 2012

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

An interventional study of non-elderly aged between 18 and 60 and elderly aged over 60 in Influenza, sponsored by Adimmune Corporation. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-12.

Sponsored by Adimmune Corporation · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Influenza

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Keywords

  • influenza
  • vaccine
  • immunogenicity
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In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 128 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Adimmune Corporation is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
128 participants (actual)

Study arms

  • Experimental
    AdimFlu-S 2011-2012

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

Interventions

  • Biologicalnon-elderly aged between 18 and 60

    one dose of 0.5mL AdimFlu-S

  • Biologicalelderly aged over 60

    one dose of 0.5mL AdimFlu-S

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What researchers measure

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).

    Time frame: 3 weeks post vaccination

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Study locations

1 site
  • National Cheng Kung University Hospital
    Tainan, Taiwan
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01411358
Lead sponsor
Adimmune Corporation
Responsible party
Sponsor
First posted
Aug 8, 2011
Start date
Aug 2011
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Jul 12, 2012

Study contacts

Gin-Hsiang Wu, MD
principal investigator · National Cheng-Kung University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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