InfluenzaPhase 4NCT01356342
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Healthy Subjects Aged Over 6 Months Old to 18 Years Old
A Phase 4 study testing AdimFlu-S 2010-2011, inactivated in people with Influenza, run by Adimmune Corporation.
Trial summary
This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects aged between 6 months old to 18 years old. All participants will be divided into three age cohorts. First, participants aged 6 through < 36 months will receive 2 doses of 0.25 mL vaccine separated by 4 weeks. Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- AdimFlu-S 2010-2011, inactivated
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to May 2011
- 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 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Boys or girls and aged 6 months old to 18 years old on the day of first vaccination;
- Subject and/or parents(s)/legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits;
- Subject must be in good physical health on the basis of medical history, physical examination;
- Subject and/or parents(s)/legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.
Who cannot join
- Subjects received influenza vaccine (Trivalent and/or A(H1N1)) 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 (URI), including the common cold or nasal congestion within 72 hours;
- Subjects with influenza-like illness as defined by the presence of fever (temperature ³38ºC) 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 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 bronchodilator use within 3 months prior to study vaccine;
- Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
- Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
- Receipt of any blood products, including immunoglobulin in the prior 3 months;
- Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;
- Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.
About this study
This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects aged between 6 months old to 18 years old. All participants will be divided into three age cohorts. First, participants aged 6 through < 36 months will receive 2 doses of 0.25 mL vaccine separated by 4 weeks. Second, participants aged 3 through < 9 years will receive 2 doses of 0.5 mL vaccine separated by 4 weeks. Third, participants aged 9 through < 18 years will receive one dose of 0.5 mL vaccine. Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions within 7 days after each vaccination, unsolicited adverse events, and serious adverse events. Sera prepared from blood samples will be collected from each subject immediately prior to, and 4 weeks after each vaccination. Anti-hemaglutinin (HA) antibody titers will be determined using the WHO haemaglutination inhibition reference technique. The analysis will be observer-blinded. All participants will be followed, either by clinical visit or by telephone contact, for 6 months after the first vaccination for safety reasons.
- Conditions
- Influenza
- Being tested
- AdimFlu-S 2010-2011, 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.
AdimFlu-S 2010-2011, inactivatedBiological
The vaccine contains not less than 90 μg haemagglutinin (HA) per mL. Per mL contains the following three strains: A/California/7/2009 (H1N1)30 μg/mL;A/Perth/16/2009 (H3N2)30 μg/mL;B/Brisbane/60/2008 30 μg/mL
6 months~<3 years;0.25 mL per injection2 injections at 4 weeks apart
3~<9 years;0.5 mL per injection2 injections at 4 weeks apart
9~<18 years;0.5 mL per injection1 injections
| Study group | Role | What they receive |
|---|---|---|
| AdimFlu-S 2010-2011, 6 months~<3 years | Experimental | Not described Receives: Biological: AdimFlu-S 2010-2011, inactivated |
| AdimFlu-S 2010-2011,3~<9 years | Experimental | Not described Receives: Biological: AdimFlu-S 2010-2011, inactivated |
| AdimFlu-S 2010-2011,9~<18 years | Experimental | Not described Receives: Biological: AdimFlu-S 2010-2011, inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2010-2011 season) of the AdimFlu-S manufactured by Adimmune Corporation.
Serum samples will be obtained prior to vaccination, and 4 weeks after each vaccination. Serum samples will be tested for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI), and assays will be performed at Adimmune Corporation designated central laboratory. Subjects will be considered to be seronegative if serum HAI titer<1:10. The seroconversion is defined as the post-vaccination serum at least 40 for whom had negative pre-vaccination or a fourfold or greater increase in HAI titers in subjects who had positive pre-vaccination serum.
Measured: Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination.
Secondary outcomes (1)
The secondary objective is to 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.
Reactogenicity events are pre-specified adverse events systematically recorded on diary cards (a grid of check boxes for each event and each day) during the immediate post-vaccination period by all participants. In general, reactogenicity events will be recorded for 7 days after each vaccination. The selection of the events to be collected systematically is based on events expected to occur with wild-type influenza infection.
Measured: Safety data will consist of reactogenicity, serious and non-serious adverse events throughout the study, including 7 days after each dose of study vaccine. Vital signs and physical examination will be performed at each clinic visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionMay 2011
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.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adimmune Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356342
- Sponsor's protocol ID
- FLU10T11B
- Status last verified
- Dec 2012
- First submitted
- 16 May 2011
- Last updated
- 28 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 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 2010-2011, in Healthy Subjects Aged Over 6 Months Old to 18 Years Old
- ClinicalTrials.gov ID
- NCT01356342
- Acronym / sponsor ID
- FLU10T11B
- Conditions
- Influenza
- Keywords
- Influenza, Vaccine, Immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Adimmune CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 May 2011 (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.
This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects aged between 6 months old to 18 years old. All participants will be divided into three age cohorts. First, participants aged 6 through < 36 months will receive 2 doses of 0.25 mL vaccine separated by 4 weeks. Second, participants aged 3 through < 9 years will receive 2 doses of 0.5 mL vaccine separated by 4 weeks. Third, participants aged 9 through < 18 years will receive one dose of 0.5 mL vaccine. Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions within 7 days after each vaccination, unsolicited adverse events, and serious adverse events. Sera prepared from blood samples will be collected from each subject immediately prior to, and 4 weeks after each vaccination. Anti-hemaglutinin (HA) antibody titers will be determined using the WHO haemaglutination inhibition reference technique. The analysis will be observer-blinded. All participants will be followed, either by clinical visit or by telephone contact, for 6 months after the first vaccination for safety reasons.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AdimFlu-S 2010-2011, 6 months~<3 years | Experimental | Biological: AdimFlu-S 2010-2011, inactivated |
| AdimFlu-S 2010-2011,3~<9 years | Experimental | Biological: AdimFlu-S 2010-2011, inactivated |
| AdimFlu-S 2010-2011,9~<18 years | Experimental | Biological: AdimFlu-S 2010-2011, inactivated |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Boys or girls and aged 6 months old to 18 years old on the day of first vaccination;
- Subject and/or parents(s)/legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits;
- Subject must be in good physical health on the basis of medical history, physical examination;
- Subject and/or parents(s)/legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.
Key exclusion criteria (15 listed)
- Subjects received influenza vaccine (Trivalent and/or A(H1N1)) 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 (URI), including the common cold or nasal congestion within 72 hours;
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-S 2010-2011, inactivatedThe vaccine contains not less than 90 μg haemagglutinin (HA) per mL. Per mL contains the following three strains: A/California/7/2009 (H1N1)30 μg/mL;A/Perth/16/2009 (H3N2)30 μg/mL;B/Brisbane/60/2008 30 μg/mL 6 months~<3 years;0.25 mL per injection2 injections at 4 weeks apart 3~<9 years;0.5 mL per injection2 injections at 4 weeks apart 9~<18 years;0.5 mL per injection1 injections | Biological | AdimFlu-S 2010-2011, 6 months~<3 years, AdimFlu-S 2010-2011,3~<9 years, AdimFlu-S 2010-2011,9~<18 years |
Primary outcome
The primary objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2010-2011 season) of the AdimFlu-S manufactured by Adimmune Corporation.
Time frame: Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination.
Serum samples will be obtained prior to vaccination, and 4 weeks after each vaccination. Serum samples will be tested for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI), and assays will be performed at Adimmune Corporation designated central laboratory. Subjects will be considered to be seronegative if serum HAI titer<1:10. The seroconversion is defined as the post-vaccination serum at least 40 for whom had negative pre-vaccination or a fourfold or greater increase in HAI titers in subjects who had positive pre-vaccination serum.
1 secondary outcome
The secondary objective is to 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.
Time frame: Safety data will consist of reactogenicity, serious and non-serious adverse events throughout the study, including 7 days after each dose of study vaccine. Vital signs and physical examination will be performed at each clinic visit.
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 28 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AdimFlu-S 2010-2011, inactivated in people with Influenza, run by Adimmune Corporation.
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 28 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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 objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2010-2011 season) of the AdimFlu-S manufactured by Adimmune Corporation. (time frame: Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination.). 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 28 Dec 2012.