InfluenzaNCT01003145

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

A study testing Influenza A (H1N1) 2009 monovalent vaccine, inactivated in people with Influenza, run by Adimmune Corporation at 3 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Influenza A (H1N1) 2009 monovalent vaccine, inactivated
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 292 participants
Where: 3 sitesTaiwan
Study dates: Sep 2009to Apr 2010
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

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

Other trials in Taiwan

About this study

Official title: 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.

Conditions: Influenza
Being tested: Influenza A (H1N1) 2009 monovalent vaccine, inactivated
Keywords: Influenza, vaccine, Immunogenicity
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Influenza A (H1N1) 2009 monovalent vaccine, inactivatedBiological
Also called AdimFlu-S (A/H1N1)

Study groups in NCT01003145
Study group	Role	What they receive
H1N1 vaccine of 15 μg HA on Day 0	Experimental	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 Receives: Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated
H1N1 vaccine of 15 μg HA on Day 0 and 21	Experimental	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 Receives: Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated
H1N1 vaccine of 30 μg HA on Day 0 and 21	Experimental	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 Receives: Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated

What is being measured

The primary outcome is the main question the study is designed to answer.

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 outcomes (1)

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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Apr 2010

First posted28 Oct 2009 (estimated)
Study startSep 2009
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Masking: None (open label)
Enrolment: 292 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01003145
Sponsor's protocol ID: FLU09001
Status last verified: Jan 2012
First submitted: 27 Oct 2009
Last updated: 20 Jan 2012
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 20817013
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.
PubMed 20659517

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Assess the Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Volunteers
ClinicalTrials.gov ID: NCT01003145
Acronym / sponsor ID: FLU09001
Conditions: Influenza
Keywords: Influenza, vaccine, Immunogenicity
Study type: Interventional
Recruitment status: Completed
Enrolment: 292 participants (actual)
Lead sponsor: Adimmune CorporationIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 28 Oct 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
H1N1 vaccine of 15 μg HA on Day 0	Experimental	Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated15 μg HA (0.5 mL) per injection, 1 injection 50 adults (aged 18~60 years) were assigned to receive one injection of H1N1 vaccine
H1N1 vaccine of 15 μg HA on Day 0 and 21	Experimental	Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated15 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
H1N1 vaccine of 30 μg HA on Day 0 and 21	Experimental	Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated30 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Influenza A (H1N1) 2009 monovalent vaccine, inactivatedAlso: AdimFlu-S (A/H1N1)	Biological	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

Primary outcome

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.

1 secondary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
Derived from this study: PubMed 20817013Kung 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.
Derived from this study: PubMed 20659517Kao 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Szu Min Hsieh principal investigator

National Taiwan University Hospital

Feng Yee Chang principal investigator

Tri-Service General Hospital (TSGH)

Yung Ching Liu principal investigator

Taipei Medical University Wang Fang Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Influenza A (H1N1) 2009 monovalent vaccine, inactivated in people with Influenza, run by Adimmune Corporation at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01003145, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2012.