InfluenzaPhase 3NCT01422512
Safety and Immunogenicity of One Dose of a Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture Administered to Adult and Elderly Subjects
A Phase 3 study testing seasonal influenza vaccine in people with Influenza, run by Novartis Vaccines at 1 site in Germany.
Trial summary
This study will evaluate safety and immunogenicity of surface, antigen, inactivated, influenza vaccine produced in mammalian cell culture when administered to adult and elderly subject. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- 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 siteGermany
- Study dates
- Sep 2011to Oct 2011
- 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
- Males and female 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 comply 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 including but not limited to: Medically significant Cancer , Medically significant advanced congestive heart failure (ie. NYHA class III and IV),Chronic obstructive pulmonary disease (COPD); Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for ≥ 5 years);Diabetes mellitus type I/II ;Advanced arteriosclerotic disease ;History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down's syndrome);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
- Individuals with known or suspected impairment/alteration of immune function 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
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- 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 potential not planning to use acceptable birth control measures, for the whole duration of the 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
- Individuals who within the past 6 months have had any seasonal or pandemic laboratory confirmed influenza disease
- Individuals who have 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 who have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days of intended study vaccination
- Individuals participating in another clinical trial
- 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
- BMI > 35 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture, Formulation 2011/2012, When Administered to Adult and Elderly Subjects
This study will evaluate safety and immunogenicity of surface, antigen, inactivated, influenza vaccine produced in mammalian cell culture when administered to adult and elderly subject.
- Conditions
- Influenza
- Being tested
- seasonal influenza vaccine
- Keywords
- seasonal 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.
seasonal influenza vaccineBiological
Also called Optaflu
Subjects received one single IM dose of trivalent Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture during the vaccination visit, according to the study protocol (follow-up period: until day 22) .
| Study group | Role | What they receive |
|---|---|---|
| cell culture derived TIV | Experimental | single dose of cell culture derived seasonal trivalent influenza vaccine (TIV) Receives: Biological: seasonal influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response as measured by hemagglutination inhibition (HI) assay
Antibody response to each influenza antigen as measured by hemagglutination inhibition (HI) at 21 days post-immunization in adult and elderly subjects in complinace with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines
Measured: 22 days
Secondary outcomes (2)
Antibody response as measured by single radial hemolysis (SRH) assay
Antibody response to each influenza antigen as measured by single radial hemolysis (SRH) at 21 days post-immunization in adult and elderly subjects in complinace with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines
Measured: 22 days
Number of subjects with solicited local and systemic reactions
To evaluate the safety of a single intramuscular (IM) injection of Optaflu in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96)
Measured: 7 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2011
- Study completionOct 2011
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Reisinger, Principal investigator, Universität Rostock / Medizinische Fakultät
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422512
- Sponsor's protocol ID
- V58_25S
- Other IDs
- 2010-024613-31
- Status last verified
- Oct 2011
- First submitted
- 23 Aug 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Loebermann M, Voss U, Meyer S, Bosse D, Fritzsche C, Klammt S, Frimmel S, Riebold D, Reisinger EC. Clinical trial to evaluate the safety and immunogenicity of a trivalent surface antigen seasonal influenza vaccine produced in mammalian cell culture and administered to young and elderly adults with and without A(H1N1) pre-vaccination. PLoS One. 2013 Aug 16;8(8):e70866. doi: 10.1371/journal.pone.0070866. eCollection 2013.
PubMed 23976960
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture, Formulation 2011/2012, When Administered to Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT01422512
- Acronym / sponsor ID
- V58_25S
- Conditions
- Influenza
- Keywords
- seasonal influenza, vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Aug 2011 (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 will evaluate safety and immunogenicity of surface, antigen, inactivated, influenza vaccine produced in mammalian cell culture when administered to adult and elderly subject.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cell culture derived TIV | Experimental | Biological: seasonal influenza vaccinesingle dose of cell culture derived seasonal trivalent influenza vaccine (TIV) |
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 female 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 comply 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 (17 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 including but not limited to: Medically significant Cancer , Medically significant advanced congestive heart failure (ie. NYHA class III and IV),Chronic obstructive pulmonary disease (COPD); Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for ≥ 5 years);Diabetes mellitus type I/II ;Advanced arteriosclerotic disease ;History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down's syndrome);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
- Individuals with known or suspected impairment/alteration of immune function 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
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 vaccineAlso: OptafluSubjects received one single IM dose of trivalent Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture during the vaccination visit, according to the study protocol (follow-up period: until day 22) . | Biological | cell culture derived TIV |
Primary outcome
Antibody response as measured by hemagglutination inhibition (HI) assay
Time frame: 22 days
Antibody response to each influenza antigen as measured by hemagglutination inhibition (HI) at 21 days post-immunization in adult and elderly subjects in complinace with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines
2 secondary outcomes
Antibody response as measured by single radial hemolysis (SRH) assay
Time frame: 22 days
Number of subjects with solicited local and systemic reactions
Time frame: 7 days post vaccination
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 12 Oct 2011.
- Derived from this study: PubMed 23976960Loebermann M, Voss U, Meyer S, Bosse D, Fritzsche C, Klammt S, Frimmel S, Riebold D, Reisinger EC. Clinical trial to evaluate the safety and immunogenicity of a trivalent surface antigen seasonal influenza vaccine produced in mammalian cell culture and administered to young and elderly adults with and without A(H1N1) pre-vaccination. PLoS One. 2013 Aug 16;8(8):e70866. doi: 10.1371/journal.pone.0070866. eCollection 2013.
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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.
Prof. Reisinger principal investigator
Universität Rostock / Medizinische Fakultät
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing seasonal influenza vaccine in people with Influenza, run by Novartis Vaccines at 1 site 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 3 inclusion and 17 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 12 Oct 2011. 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 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?
Antibody response as measured by hemagglutination inhibition (HI) assay (time frame: 22 days). 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 NCT01422512, 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 12 Oct 2011.