Influenza DiseasePhase 2NCT00918268
Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2009/2010 Recommended in Northern Hemisphere in Non-elderly Adult and in Elderly Subjects
A Phase 2 study testing Influenza vaccine in people with Influenza Disease, run by Novartis Vaccines at 3 sites in Italy.
Trial summary
Annual trial for registration influenza vaccine with the strain composition for season 2009/2010. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Disease
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesItaly
- Study dates
- Jun 2009to Jul 2009
- 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
- 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry;
- able to comply with all the study requirements;
- in general good health as determined by:medical history, physical examination and- clinical judgment of the investigator Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.
Who cannot join
- They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:
- Cancer, except for localized skin cancer;
- Advanced congestive heart failure
- Chronic obstructive pulmonary disease (COPD);
- Autoimmune disease (including rheumatoid arthritis);
- Acute or progressive hepatic disease;
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- Acute or progressive renal disease;
- Severe neurological or psychiatric disorder
- Severe asthma
- They have 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 ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
- They have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:- receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) 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 HIV infection or HIV-related disease;
- They have a known or suspected history of drug or alcohol abuse;
- They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
- Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing age do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom or diaphragm), intrauterine device (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry;
- Within the past 12 months, they have:- received more than one injection of influenza vaccine
- Within the past 6 months, they have:-had laboratory confirmed influenza disease,- received influenza vaccine;
- Within the past 4 weeks they have received:-another vaccine;-any investigational agent;
- They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days;
- They have experienced fever (i.e., axillary temperature≥ 38°C) within the last 3 days;
- They are taking part in another clinical study;
- They have any condition which, in the opinion of the investigator,might interfere with the evaluation of the study objectives;
- They are severely obese with Body Mass Index (BMI) > 35;
- Site personnel involved in the evaluation of safety and their immediate relatives are excluded from participation.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
Chieti, 66100
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37 ----- Satellite sites: (a) Distretto Sanitario di Base, Via Don Minzoni, Lanciano (CH) and (b) Distretto Sanitario di Base, Via Polidoro, Fossacesia (CH))
Lanciano, 66034
Pianiga Distretto n. 2 - Area Sud - Azienda ULSS 13 Mirano-Via Nazionale 48
Pianiga, 30030
About this study
Official title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2009-2010, When Administered to Non-elderly Adult and Elderly Subjects
Annual trial for registration influenza vaccine with the strain composition for season 2009/2010.
- Conditions
- Influenza Disease
- Being tested
- Influenza vaccine
- Keywords
- Influenza vaccine
- 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 vaccineBiological
One 0.5mL dose of Inactivated, Influenza Vaccine using the strain composition 2009/2010
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccine | Experimental | Not described Receives: Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly adult and elderly subjects
Measured: 21(-1/+5) days
Evaluation of safety of a single intramuscular injection of influenza vaccine in non elderly adult and elderly subjects
Measured: 21(-1/+5) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza DiseaseStudies 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
- 130 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
- NCT00918268
- Sponsor's protocol ID
- V71_10S
- Other IDs
- 2009-010598-19, 2009
- Status last verified
- Apr 2012
- First submitted
- 9 Jun 2009
- Last updated
- 23 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 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 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2009-2010, When Administered to Non-elderly Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT00918268
- Acronym / sponsor ID
- V71_10S
- Conditions
- Influenza Disease
- Keywords
- Influenza vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Jun 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.
Annual trial for registration influenza vaccine with the strain composition for season 2009/2010.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine | Experimental | Biological: Influenza vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry;
- able to comply with all the study requirements;
- in general good health as determined by:medical history, physical examination and- clinical judgment of the investigator Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.
Key exclusion criteria (23 listed)
- They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:
- They have 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 ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
- They have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:- receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) 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 HIV infection or HIV-related disease;
- They have a known or suspected history of drug or alcohol abuse;
- They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
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 vaccineOne 0.5mL dose of Inactivated, Influenza Vaccine using the strain composition 2009/2010 | Biological | Influenza vaccine |
Primary outcome
Evaluation of the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly adult and elderly subjects
Time frame: 21(-1/+5) days
Evaluation of safety of a single intramuscular injection of influenza vaccine in non elderly adult and elderly subjects
Time frame: 21(-1/+5) days
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 23 Apr 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
3 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 Influenza vaccine in people with Influenza Disease, run by Novartis Vaccines at 3 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 23 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 23 Apr 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 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?
Evaluation of the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly adult and elderly subjects (time frame: 21(-1/+5) days). 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?
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 23 Apr 2012; AzTrials last refreshed its copy on 7 Nov 2026.