InfluenzaPhase 2NCT00956449
Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) [Ph.Eur], Formulation 2009-2010, When Administered to Non-Elderly Adult and Elderly Subjects
A Phase 2 study testing Seasonal Influenza Vaccine in people with Influenza and Seasonal Influenza, run by Novartis at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Seasonal Influenza
- What is being tested?
- Seasonal Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited Kingdom
- 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
- Subjects eligible for enrollment into this study are male and female adults who are:
- ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry;
- able to comply with all study requirements;
- in good health as determined by:
- medical history,
- physical examination,
- clinical judgment of the investigator.
Who cannot join
- Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
- 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)
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- Acute or progressive hepatic disease
- Acute or progressive renal disease
- Severe neurological or psychiatric disorder
- Severe Asthma
- 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, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin).
- 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 parental or oral cortical steroid 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 derivatives within the past 3 months and for the full length of the study,
- Suspected or known HIV infection or HIV-related disease.
- Known or suspected history of drug or alcohol abuse.
- They have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
- Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days). Females who are pregnant or nursing (breastfeeding) mothers or females of childbearing age who do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (oral, injection, transdermal patch, implant, cervical ring), barrier (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.
- Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months
- Within the past 4 weeks they have received: another vaccine or any investigational agent.
- 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
- Simultaneous participation in another clinical study.
- Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.
- Severely obese with Body Mass Index (BMI) > 35
- Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Single Center, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine [Ph.Eur], Formulation 2009/2010, When Administered to Non-Elderly Adult and Elderly Subjects
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).
- Conditions
- Influenza, Seasonal Influenza
- Being tested
- Seasonal Influenza Vaccine
- Keywords
- flu, influenza, seasonal influenza, influenza vaccine antigen, immunogenicity, safety, tolerability, antibody response, intra muscular, elderly, non-elderly
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal Influenza VaccineBiological
1 dose of Influenza Vaccine Surface Antigen, Inactivated
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Seasonal Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity and tolerability of the Flu vaccines is being measured
Measured: 2 - 21 days
Secondary outcomes (1)
To evaluate safety of a single IM (intramuscular) dose of the subunit vaccine of Influenza Vaccine Surface Antigen, Inactivated of Influenza Vaccine
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 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 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956449
- Sponsor's protocol ID
- V78_07S
- Other IDs
- 2009-011004-33, 2009
- Status last verified
- Mar 2017
- First submitted
- 8 Aug 2009
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Center, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine [Ph.Eur], Formulation 2009/2010, When Administered to Non-Elderly Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT00956449
- Acronym / sponsor ID
- V78_07S
- Conditions
- Influenza, Seasonal Influenza
- Keywords
- flu, influenza, seasonal influenza, influenza vaccine antigen, immunogenicity, safety, tolerability, antibody response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Aug 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.
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Seasonal Influenza Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects eligible for enrollment into this study are male and female adults who are:
Key exclusion criteria (27 listed)
- Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
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 |
|---|---|---|
| Seasonal Influenza Vaccine1 dose of Influenza Vaccine Surface Antigen, Inactivated | Biological | 1 |
Primary outcome
Immunogenicity and tolerability of the Flu vaccines is being measured
Time frame: 2 - 21 days
1 secondary outcome
To evaluate safety of a single IM (intramuscular) dose of the subunit vaccine of Influenza Vaccine Surface Antigen, Inactivated of Influenza Vaccine
Time frame: 21 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 28 Mar 2017.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Seasonal Influenza Vaccine in people with Influenza and Seasonal Influenza, run by Novartis at 1 site in United Kingdom.
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 7 inclusion and 27 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 2017. 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 United Kingdom. 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?
Immunogenicity and tolerability of the Flu vaccines is being measured (time frame: 2 - 21 days). 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 2017.