InfluenzaPhase 4NCT01512056
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
A Phase 4 study testing AdimFlu-S in people with Influenza, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- AdimFlu-S
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2011to Mar 2012
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and non-pregnant females and aged more than 18 years;
- Willing and able to adhere to visit schedules and all study requirements;
- Subjects read and signed the study-specific informed consent.
Who cannot join
- Subject or his/her family is employed by the participated hospital;
- Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
- History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
- Personal or family history of Guillain-Barré Syndrome;
- An acute febrile illness within 1 week prior to vaccination;
- Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
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- Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) 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 during the study.
- Patients who receive hemodialysis therapy less than 3 months.
- Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
- Immunodeficiency, or under immunosuppressive treatment.
- Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
- Receipt of any blood products, including immunoglobulin in the prior 3 months;
- Any severe illness needed to be hospitalization within three months.
- Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Junne Ming Sung, MD, 886-6-2353535 ext. 2594, jmsung@mail.ncku.edu.tw
Yu Tzu Chang, MD and Msc, 886-6-2353535 ext. 2593, kangxiemperor@gmail.com
About this study
The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012).
Read the detailed description
The immune response to influenza vaccine was poor in dialysis population than general population. The investigators want to evaluate another booster vaccination can improve the immune response in dialysis population. All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). The investigators will collect serum of participants 3 weeks, 6 weeks, 9 weeks and 18 weeks post vaccination and evaluate the difference of immune response in these 3 groups.
- Conditions
- Influenza
- Being tested
- AdimFlu-S
- Keywords
- Influenza vaccine, dialysis, vaccine, Seroprotection, Seroresponse, Seroconversion, Safety of the vaccine
- Medical subject headings
- Influenza, Human, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdimFlu-SDrug
All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). Each dose of vaccine contains 15μg antigen of each virus strain suggested by WHO (A/California/7/2009 (H1N1);A/Perth/16/2009 (H3N2);B/Brisbane/60/2008).
| Study group | Role | What they receive |
|---|---|---|
| the immunogenicity profiles of the AdimFlu-S | Experimental | Experimental group: to receive either only one dose of influenza vaccine at day 0 or one more booster vaccination 3 weeks later.
Negative control group: dialysis patients who refused to receive influenza vaccination. Receives: Drug: AdimFlu-S |
| The safety outcome of the vaccine | No intervention | Any adverse effect, including systemic or local site, will be recorded during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of antibody titer before and after influenza vaccination
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay will also be used to evaluate the immune response post vaccination. The immune response based on microNT-ELISA antibody titers would be reported as antibody titer ≥1: 40 or ≥ 1:160 respectively because no threshold of protective NT antibody titer is clearly defined by the international guidelines.
Measured: 18 weeks
Secondary outcomes (3)
Seroresponse rate
The seroconversion is defined as the HI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HI serum titer or a four-fold or greater increase in HI titers in subjects who had a positive pre-vaccination HAI serum titer.
Measured: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
Seroresponse rate
The seroresponse is defined as HI or micro-NT titer of the post-vaccination serum is at least 4-fold increase of the HI or micro-NT titer after vaccination.
Geometric mean folds increase in HI or micro-NT titer.
Measured: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
the safety and tolerability profiles of the vaccine
evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation.
Measured: 0, 3 week, 6 weeks, 9 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512056
- Sponsor's protocol ID
- BR-100-086
- Status last verified
- Jan 2012
- First submitted
- 1 Nov 2011
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
- ClinicalTrials.gov ID
- NCT01512056
- Acronym / sponsor ID
- BR-100-086
- Conditions
- Influenza
- Keywords
- Influenza vaccine, dialysis, vaccine, Seroprotection, Seroresponse, Seroconversion, Safety of the vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 19 Jan 2012 (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.
The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012).
Detailed description
The immune response to influenza vaccine was poor in dialysis population than general population. The investigators want to evaluate another booster vaccination can improve the immune response in dialysis population. All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). The investigators will collect serum of participants 3 weeks, 6 weeks, 9 weeks and 18 weeks post vaccination and evaluate the difference of immune response in these 3 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the immunogenicity profiles of the AdimFlu-S | Experimental | Drug: AdimFlu-SExperimental group: to receive either only one dose of influenza vaccine at day 0 or one more booster vaccination 3 weeks later. Negative control group: dialysis patients who refused to receive influenza vaccination. |
| The safety outcome of the vaccine | No intervention | –Any adverse effect, including systemic or local site, will be recorded during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and non-pregnant females and aged more than 18 years;
- Willing and able to adhere to visit schedules and all study requirements;
- Subjects read and signed the study-specific informed consent.
Key exclusion criteria (15 listed)
- Subject or his/her family is employed by the participated hospital;
- Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
- History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
- Personal or family history of Guillain-Barré Syndrome;
- An acute febrile illness within 1 week prior to vaccination;
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 |
|---|---|---|
| AdimFlu-SAll enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). Each dose of vaccine contains 15μg antigen of each virus strain suggested by WHO (A/California/7/2009 (H1N1);A/Perth/16/2009 (H3N2);B/Brisbane/60/2008). | Drug | the immunogenicity profiles of the AdimFlu-S |
Primary outcome
Change of antibody titer before and after influenza vaccination
Time frame: 18 weeks
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay will also be used to evaluate the immune response post vaccination. The immune response based on microNT-ELISA antibody titers would be reported as antibody titer ≥1: 40 or ≥ 1:160 respectively because no threshold of protective NT antibody titer is clearly defined by the international guidelines.
3 secondary outcomes
Seroresponse rate
Time frame: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
Seroresponse rate
Time frame: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
the safety and tolerability profiles of the vaccine
Time frame: 0, 3 week, 6 weeks, 9 weeks, 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AdimFlu-S in people with Influenza, run by National Cheng-Kung University Hospital at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 19 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 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junne Ming Sung, MD (886-6-2353535 ext. 2594, jmsung@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of antibody titer before and after influenza vaccination (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2012.