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

This study has been completed.
Sponsor:
Information provided by:
Adimmune Corporation
ClinicalTrials.gov Identifier:
NCT01003145
First received: October 27, 2009
Last updated: January 19, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Influenza
 Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Clinical Study to Assess the Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Adimmune Corporation:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 292
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: AdimFlu-S (A/H1N1)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003145

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Taipei Medical University Wang Fang Hospital
Taipei, Taiwan
Sponsors and Collaborators
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
  More Information

No publications provided by Adimmune Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeffrey Chen / Vice President, Adimmune Corporation
ClinicalTrials.gov Identifier: NCT01003145     History of Changes
Other Study ID Numbers: FLU09001
Study First Received: October 27, 2009
Last Updated: January 19, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Adimmune Corporation:
Influenza
vaccine
Immunogenicity

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013