Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Adults and Elders

January 19, 2012 updated by: Adimmune Corporation

A Clinical Study to Assess the Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Volunteers

This was a randomized, laboratory-blinded study in healthy male and non-pregnant female designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 vaccine (AdimFlu-S). In the adult cohort, all volunteers were randomized in a 1:1:1 ratio to receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart, 2 injections of AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart or 1 injection of AdimFlu-S (A/H1N1) 15 mcg HA. In the elders cohort, all volunteers were randomized in a 1:1 ratio to receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart or 2 injections of AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart.

Following immunization, safety was measured by assessment of adverse events for 6 weeks following the first vaccination, serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination; and reactogenicity to the vaccines for 7 days following each vaccination. Immunogenicity testing included hemagglutinin inhibition (HAI) testing on serum obtained before first vaccination, and three and six weeks after first vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

292

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Tri-Service General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Medical University Wang Fang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or non-pregnant females and age ≧ 18 years;
  • Willing and able to adhere to visiting schedules and all study requirements;
  • In good physical health on the basis of medical history, physical examination;
  • Subject should read and sign the study-specific informed consent.

Exclusion Criteria:

  • Subject ever received influenza vaccine within the previous 6 months;
  • History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication (AdimFlu-S (A/H1N1));
  • Personal or family history of Guillain-Barré Syndrome;
  • An acute febrile illness within the last 72 hours prior to vaccination;
  • Subjects, with bleeding or any coagulation disorder, who receive anticoagulants in the preceding 3 weeks, thus posing a contraindication for intramuscular injection;
  • Subjects with influenza-like illness as defined by the presence of fever (temperature ≧38.5℃) 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, lactating or likely to become pregnant during the study. Women of childbearing potential who disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study;
  • Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
  • Immunodeficiency, immunosuppressive or household contact with immunosuppression;
  • History of wheezing or have been using bronchodilator within 3 months prior to study vaccination;
  • Receipt of live virus vaccine within 1 month prior to study vaccination or expected receipt within 2 months after first study vaccination;
  • Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt of vaccination within 3 weeks after the immunogenicity evaluation period;
  • Receipt of any blood products, including immunoglobulin in the prior 3 months;
  • Underlying condition, in the investigator's opinion, that may be inappropriate for vaccination;
  • Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: H1N1 vaccine of 15 μg HA on Day 0

15 μg HA (0.5 mL) per injection, 1 injection

50 adults (aged 18~60 years) were assigned to receive one injection of H1N1 vaccine
Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated
Other Names:
  • AdimFlu-S (A/H1N1)
Experimental: H1N1 vaccine of 15 μg HA on Day 0 and 21

15 μg HA (0.5 mL) per injection, 2 injections

50 adults (aged 18~60 years) and 50 elders (aged over 60 years) were assigned to receive two injections of H1N1 vaccine 3 weeks apart
Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated
Other Names:
  • AdimFlu-S (A/H1N1)
Experimental: H1N1 vaccine of 30 μg HA on Day 0 and 21

30 μg HA (1 mL) per injection, 2 injections

50 adults (aged 18~60 years) and 50 elders (aged over 60 years) were assigned to receive two injections of H1N1 vaccine 3 weeks apart
Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated
Other Names:
  • AdimFlu-S (A/H1N1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary immunogenicity objective is to assess the antibody response following a single dose of study vaccine, stratified by age of recipient, when administered at the 15 or 30 μg HA doses.
The primary safety objective of this study is to assess the safety of the study vaccine when administered at the 15 or 30 μg dose.

Secondary Outcome Measures

Outcome Measure
The secondary immunogenicity objective is to assess the antibody response following 2 doses of study vaccine, stratified by age of recipient, when administered at the 15 or 30 μg HA doses.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adimmune Corporation

Investigators

  • Principal Investigator: Szu Min Hsieh, National Taiwan University Hospital
  • Principal Investigator: Feng Yee Chang, Tri-Service General Hospital
  • Principal Investigator: Yung Ching Liu, Taipei Medical University Wang Fang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimate)

October 28, 2009

Study Record Updates

Last Update Posted (Estimate)

January 20, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLU09001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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