Seasonal InfluenzaPhase 2NCT01151059
Safety and Immunogenicity of One Dose of Inactivated Trivalent Flu Vaccine Administered to Non-elderly Adult and Elderly Subjects
A Phase 2 study testing Trivalent subunit inactivated flu vaccine, Formulation 2010-2011 in people with Seasonal Influenza, run by Novartis Vaccines at 5 sites in Italy.
Trial summary
The present study will evaluate the safety and immunogenicity in healthy people (non-elderly adult and elderly subjects) after one intramuscular (IM) dose of trivalent subunit inactivated flu vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- Trivalent subunit inactivated flu vaccine, Formulation 2010-2011
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 5 sitesItaly
- Study dates
- Jun 2010to Jul 2010
- Phase
- Phase 2
- 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 and females volunteers of 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry
- Individuals able to complain with all the study requirements
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Who cannot join
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study
- Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to: cancer, advanced congestive heart failure, chronic obstructive pulmonary disease (COPD), autoimmune diseases, acute or progressive hepatic and renal disease, severe neurological or psychiatric disorder and severe asthma
- Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to eggs/eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate)
- Individuals with known or suspected impairment/alteration of immune function resulting, for example, from: receipt of immunosuppressive therapy within the past 60 days and for the full length of the study, receipt of immunostimulants, receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study and suspected or known human immunodeficiency virus (HIV) infection or HIV-related disease
- Individuals with known or suspected history of drug or alcohol abuse
- Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures for the whole duration of the study
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- Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
- Individuals within the past 6 months, they have had any seasonal or pandemic laboratory confirmed influenza disease and received any seasonal or pandemic influenza vaccine
- Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days
- Individuals that have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days of intended study vaccination
- Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study
- Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines
- Individuals who have ever received blood/blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks and for the full length of the study
- Individuals who are part of study personnel or close family members conducting this study
- Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
- BMI > 35 kg/m2
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
Chieti, 66100
Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Via Fossato di Mortara, 64/b
Ferrara, 44100
Dipartimento di Scienze della Salute Università di Genova Via Pastore, 1
Genova, 16132
Centro Satellite. ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37
Lanciano, 66034
Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona, 20
Milan, 20127
About this study
Official title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL® S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2010-2011, When Administered to Non-elderly Adult and Elderly Subjects
The present study will evaluate the safety and immunogenicity in healthy people (non-elderly adult and elderly subjects) after one intramuscular (IM) dose of trivalent subunit inactivated flu vaccine.
- Conditions
- Seasonal Influenza
- Being tested
- Trivalent subunit inactivated flu vaccine, Formulation 2010-2011
- Keywords
- seasonal influenza, vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent subunit inactivated flu vaccine, Formulation 2010-2011Biological
This phase II is performed as a multicenter study site in non-elderly adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit Receives: Biological: Trivalent subunit inactivated flu vaccine, Formulation 2010-2011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in non-elderly adult and elderly subjects
Measured: 22 days, including the follow-up period
Secondary outcomes (1)
To evaluate the safety of a single IM injection of trivalent subunit inactivated FLU vaccine in non-elderly adult and elderly subjects
Measured: 22 days, including the follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151059
- Sponsor's protocol ID
- V71_19S
- Status last verified
- Mar 2012
- First submitted
- 23 Jun 2010
- Last updated
- 28 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL® S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2010-2011, When Administered to Non-elderly Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT01151059
- Acronym / sponsor ID
- V71_19S
- Conditions
- Seasonal Influenza
- Keywords
- seasonal influenza, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Jun 2010 (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 present study will evaluate the safety and immunogenicity in healthy people (non-elderly adult and elderly subjects) after one intramuscular (IM) dose of trivalent subunit inactivated flu vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Biological: Trivalent subunit inactivated flu vaccine, Formulation 2010-2011No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females volunteers of 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry
- Individuals able to complain with all the study requirements
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Key exclusion criteria (16 listed)
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study
- Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to: cancer, advanced congestive heart failure, chronic obstructive pulmonary disease (COPD), autoimmune diseases, acute or progressive hepatic and renal disease, severe neurological or psychiatric disorder and severe asthma
- Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to eggs/eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate)
- Individuals with known or suspected impairment/alteration of immune function resulting, for example, from: receipt of immunosuppressive therapy within the past 60 days and for the full length of the study, receipt of immunostimulants, receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study and suspected or known human immunodeficiency virus (HIV) infection or HIV-related disease
- Individuals with known or suspected history of drug or alcohol abuse
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 |
|---|---|---|
| Trivalent subunit inactivated flu vaccine, Formulation 2010-2011This phase II is performed as a multicenter study site in non-elderly adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22). | Biological | Group 1 |
Primary outcome
To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in non-elderly adult and elderly subjects
Time frame: 22 days, including the follow-up period
1 secondary outcome
To evaluate the safety of a single IM injection of trivalent subunit inactivated FLU vaccine in non-elderly adult and elderly subjects
Time frame: 22 days, including the follow-up period
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 Mar 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.
Novartis Vaccines study chair
Novartis Vaccines
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trivalent subunit inactivated flu vaccine, Formulation 2010-2011 in people with Seasonal Influenza, run by Novartis Vaccines at 5 sites in Italy.
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 16 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 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in non-elderly adult and elderly subjects (time frame: 22 days, including the follow-up period). 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 Mar 2012.