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Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01752881
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Information provided by (Responsible Party):

Study Description
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 three weeks 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).

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza vaccine (split virion, inactivated) Biological: AdimFlu-S Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects
Study Start Date : August 2012
Primary Completion Date : August 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: AdimFlu-S Biological: Influenza vaccine (split virion, inactivated)

AdimFlu-S, Inactivated Influenza Vaccine Trivalent Types A and B (Split) Formulation 2012-2013

Dosage: 0.5mL/per syringe

Administration route: Intramuscular Injection, once

Other Name: AdimFlu-S Influenza Vaccine
Biological: AdimFlu-S

Outcome Measures

Primary Outcome Measures :
  1. Immunogenicity endpoint: Seroprotection rate [ Time Frame: At 3 weeks after vaccination ]
    Seroprotection rate is defined as the proportion of subjects with HAI titer ≥ 1:40.

  2. Immunogenicity endpoint: Seroconversion rate [ Time Frame: At 3 weeks after vaccination ]
    The seroconversion is defined as the HAI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HAI serum titer or a four-fold or greater increase in HAI titers in subjects who had a positive pre-vaccination HAI serum titer. The seropositive is defined as the HAI titer ≥ 1:10, and the seronegative is defined as HAI titer < 1:10.

  3. Immunogenicity endpoint: Geometric mean folds increase in HAI titer [ Time Frame: At 3 weeks after vaccination ]

Secondary Outcome Measures :
  1. Safety: Reactogenicity events [ Time Frame: 7 days after vaccination ]
    Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after vaccination. The selection of the events to be collected systematically is based on events expected to occur with wild-type influenza infection including fever (≥38°C), runny nose or nasal congestion, cough, sore throat, headache, muscle aches, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions will also be evaluated that include soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.

  2. Safety: Serious and non-serious adverse events [ Time Frame: Through day 21 post vaccination ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752881

National Cheng Kung University Hospital
Tainan, Taiwan
Sponsors and Collaborators
Adimmune Corporation
Principal Investigator: Chih-Jen Chang, MD National Cheng-Kung University Hospital
More Information

Responsible Party: Adimmune Corporation
ClinicalTrials.gov Identifier: NCT01752881     History of Changes
Other Study ID Numbers: FLU12T13A
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

Keywords provided by Adimmune Corporation:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs