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

Primary Purpose

Influenza

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Influenza A (H1N1) 2009 monovalent vaccine, inactivated

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, vaccine, Immunogenicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

H1N1 vaccine of 15 μg HA on Day 0

H1N1 vaccine of 15 μg HA on Day 0 and 21

H1N1 vaccine of 30 μg HA on Day 0 and 21

Arm Description

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

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

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

Outcomes

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.

Full Information

NCT ID

NCT01003145

First Posted

October 27, 2009

Last Updated

January 19, 2012

Sponsor

Adimmune Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01003145

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Adimmune Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, vaccine, Immunogenicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Masking

None (Open Label)

Allocation

Randomized

Enrollment

292 (Actual)

8. Arms, Groups, and Interventions

Arm Title

H1N1 vaccine of 15 μg HA on Day 0

Arm Type

Experimental

Arm Description

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

Arm Title

H1N1 vaccine of 15 μg HA on Day 0 and 21

Arm Type

Experimental

Arm Description

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

Arm Title

H1N1 vaccine of 30 μg HA on Day 0 and 21

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Influenza A (H1N1) 2009 monovalent vaccine, inactivated

Other Intervention Name(s)

AdimFlu-S (A/H1N1)

Primary Outcome Measure Information:

Title

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.

Title

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 Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Szu Min Hsieh

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Feng Yee Chang

Organizational Affiliation

Tri-Service General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yung Ching Liu

Organizational Affiliation

Taipei Medical University Wang Fang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

Facility Name

Taipei Medical University Wang Fang Hospital

City

Taipei

Country

Taiwan

Facility Name

Tri-Service General Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

20817013

Citation

Kung HC, Huang KC, Kao TM, Lee YC, Chang FY, Wang NC, Liu YC, Lee WS, Liu HJ, Chen CI, Chen CH, Huang LM, Hsieh SM. A clinical study to assess the immunogenicity and safety of a monovalent 2009 influenza A (H1N1) vaccine in an area with low-level epidemics of pandemic influenza. Vaccine. 2010 Oct 21;28(45):7337-43. doi: 10.1016/j.vaccine.2010.08.073. Epub 2010 Sep 17.

Results Reference

derived

PubMed Identifier

20659517

Citation

Kao TM, Hsieh SM, Kung HC, Lee YC, Huang KC, Huang LM, Chang FY, Wang NC, Liu YC, Lee WS, Liu HE, Chen CI, Chen CH. Immune response of single dose vaccination against 2009 pandemic influenza A (H1N1) in the Taiwanese elderly. Vaccine. 2010 Aug 31;28(38):6159-63. doi: 10.1016/j.vaccine.2010.07.026. Epub 2010 Jul 24.

Results Reference

derived

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

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