Seasonal InfluenzaPhase 3NCT01147081
Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011
A Phase 3 study testing BEGRIVAC in people with Seasonal Influenza, run by Novartis Vaccines at 3 sites in Germany.
Trial summary
Annual trial for registration influenza vaccine Begrivac with strain composition for season 2010/2011. 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?
- BEGRIVAC
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 3 sitesGermany
- Study dates
- Jun 2010to Jul 2010
- 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
- Male and female volunteers of 18 years of age and older, mentally competent, willing and able to give written informed consent prior to study entry;
- Individuals able to comply with all the study requirements;
- Individuals in 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
- 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, 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;
- 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 ovalbumin, chicken protein, chicken feathers, influenza viral protein, Polymyxin B;
- Individuals with 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;
- suspected or known HIV infection or HIV-related disease;
- Individuals with known or suspected history of drug or alcohol abuse;
- 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;
- 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 with spermicide or diaphragm with spermicide),,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;
- Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study;
- Individuals that within the past 12 months have received more than one injection of influenza vaccine;
- Individuals that within the past 6 months have:
- had laboratory confirmed seasonal or pandemic influenza disease;
- received 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 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 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.
- BMI > 35 kg/m2
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Universität Rostock/Medizinische Fakultät
Ernst-Heydemann Str. 6, Rostock, 18057
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20359
Study site
Magdeburg, Saxony-Anhalt, 39120
About this study
Official title: A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of Begrivac®, Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011 When Administered to Adult and Elderly Subjects
Annual trial for registration influenza vaccine Begrivac with strain composition for season 2010/2011.
Read the detailed description
At enrolment, subjects were stratified into two age strata (18 to 60 years, over 60 years). Total duration of the study is three weeks. Vaccinations were to be administered on day 1. Blood samples were collected at day 1 (baseline, before the vaccination) and at day 22 (three weeks after the vaccination). Sera were tested by Hemagglutination Inhibition (HI) assay. Safety was assessed until 3 weeks after the vaccination.
- Conditions
- Seasonal Influenza
- Being tested
- BEGRIVAC
- 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.
BEGRIVACBiological
126 healthy subjects enrolled to receive, in open-label manner, one dose of Begrivax (influenza vaccine)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Biological: BEGRIVAC |
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 1 and on Day 22, and evaluation of safety of Begrivac
Measured: 22 days (-1/+5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 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
- NCT01147081
- Sponsor's protocol ID
- V44_14S
- Other IDs
- 2010-018371-18
- Status last verified
- Jan 2012
- First submitted
- 17 Jun 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Loebermann M, Anders G, Brestrich G, Fritzsche C, Klammt S, Borso D, Frimmel S, Riebold D, Reisinger EC. Safety and immunogenicity of a trivalent single dose seasonal influenza vaccine containing pandemic A(H1N1) antigen in younger and elderly subjects: a phase III open-label single-arm study. Vaccine. 2011 Feb 1;29(6):1228-34. doi: 10.1016/j.vaccine.2010.11.092. Epub 2010 Dec 15.
PubMed 21167116
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. 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 Begrivac®, Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011 When Administered to Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT01147081
- Acronym / sponsor ID
- V44_14S
- Conditions
- Seasonal Influenza
- Keywords
- Influenza vaccine, Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 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.
Annual trial for registration influenza vaccine Begrivac with strain composition for season 2010/2011.
Detailed description
At enrolment, subjects were stratified into two age strata (18 to 60 years, over 60 years). Total duration of the study is three weeks. Vaccinations were to be administered on day 1. Blood samples were collected at day 1 (baseline, before the vaccination) and at day 22 (three weeks after the vaccination). Sera were tested by Hemagglutination Inhibition (HI) assay. Safety was assessed until 3 weeks after the vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: BEGRIVAC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female volunteers of 18 years of age and older, mentally competent, willing and able to give written informed consent prior to study entry;
- Individuals able to comply with all the study requirements;
- Individuals in 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 (32 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:
- 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 ovalbumin, chicken protein, chicken feathers, influenza viral protein, Polymyxin B;
- Individuals with 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:
- 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 |
|---|---|---|
| BEGRIVAC126 healthy subjects enrolled to receive, in open-label manner, one dose of Begrivax (influenza vaccine) | Biological | Arm 1 |
Primary outcome
Evaluation of antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 1 and on Day 22, and evaluation of safety of Begrivac
Time frame: 22 days (-1/+5)
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 5 Jan 2012.
- Derived from this study: PubMed 21167116Loebermann M, Anders G, Brestrich G, Fritzsche C, Klammt S, Borso D, Frimmel S, Riebold D, Reisinger EC. Safety and immunogenicity of a trivalent single dose seasonal influenza vaccine containing pandemic A(H1N1) antigen in younger and elderly subjects: a phase III open-label single-arm study. Vaccine. 2011 Feb 1;29(6):1228-34. doi: 10.1016/j.vaccine.2010.11.092. Epub 2010 Dec 15.
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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 3 study testing BEGRIVAC in people with Seasonal Influenza, run by Novartis Vaccines 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 4 inclusion and 32 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 5 Jan 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 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 1 and on Day 22, and evaluation of safety of Begrivac (time frame: 22 days (-1/+5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01147081, which also lists 1 linked publication.
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 5 Jan 2012.