Seasonal InfluenzaPhase 3NCT00945841
Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010
A Phase 3 study testing inactivated split influenza vaccine in people with Seasonal Influenza, run by Novartis at 3 sites in Germany.
Trial summary
This study is an annual trial for registration of inactivated split influenza vaccine with 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
- Seasonal Influenza
- What is being tested?
- inactivated split influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesGermany
- Study dates
- Jun 2009to Jun 2009
- Phase
- Phase 3
- 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. 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
- 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);
Show all 29Show fewer
- 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 ovalbumin, 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). Female who pregnant of nursing (breastfeeding) mothers of 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;
- 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
3 sites in 1 country.
Germany3 sites
Site 2
Giessen, 35392
Site 1
Herborn, 35745
Site 3
Marburg, 35033
About this study
Official title: A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of a Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010 When Administered to Adult and Elderly Subjects
This study is an annual trial for registration of inactivated split influenza vaccine with strain composition for season 2009/2010.
- Conditions
- Seasonal Influenza
- Being tested
- inactivated split influenza vaccine
- Keywords
- influenza vaccine, 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.
inactivated split influenza vaccineBiological
1 dose of inactivated split influenza vaccine, using the strain composition 2009/2010
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Biological: inactivated split influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
Measured: 21 days (-1/+7)
Evaluation of safety of inactivated split influenza vaccine
Measured: 21 days (-1/+7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2009
- Study completionJun 2009
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 3
- Primary purpose
- Prevention
- Allocation
- 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
- NCT00945841
- Sponsor's protocol ID
- V44_13S
- Other IDs
- 2009-010565-23, 2009
- Status last verified
- Apr 2017
- First submitted
- 22 Jul 2009
- Last updated
- 7 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of a Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010 When Administered to Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT00945841
- Acronym / sponsor ID
- V44_13S
- Conditions
- Seasonal Influenza
- Keywords
- influenza vaccine, vaccine
- Phase
- Phase 3
- 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
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Jul 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.
This study is an annual trial for registration of inactivated split influenza vaccine with strain composition for season 2009/2010.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Biological: inactivated split 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
- ≥ 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:
Key exclusion criteria (29 listed)
- 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:
- 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 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:
- 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 |
|---|---|---|
| inactivated split influenza vaccine1 dose of inactivated split influenza vaccine, using the strain composition 2009/2010 | Biological | 1 |
Primary outcome
Evaluation of antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
Time frame: 21 days (-1/+7)
Evaluation of safety of inactivated split influenza vaccine
Time frame: 21 days (-1/+7)
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 7 Apr 2017.
Related trials for Seasonal Influenza
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
RecruitingPhase 1
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
Influenza Prevention, Seasonal Influenza
Not yet recruitingPhase 1
Phase I Clinical Trial of Trivalent Inactivated Split Influenza Virus Vaccine (MDCK Cell)
Seasonal Influenza
Not yet recruitingPhase 4
A Study of Updated mRNA Seasonal Influenza Vaccines
Seasonal Influenza
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 3 study testing inactivated split influenza vaccine in people with Seasonal Influenza, run by Novartis at 3 sites in Germany.
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 29 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 7 Apr 2017. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21 (time frame: 21 days (-1/+7)). 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 7 Apr 2017.