InfluenzaPhase 3NCT00306527
Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly
A Phase 3 study testing Cell culture derived influenza vaccine and egg-derived influenza subunit vaccine in people with Influenza, run by Novartis Vaccines at 5 sites in Poland.
Trial summary
The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study… 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?
- Cell culture derived influenza vaccine and egg-derived influenza subunit vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,235 participants
- Where
- 5 sitesPoland
- Study dates
- Sep 2005to Apr 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to < 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
- Mentally competent to understand the nature, the scope and the consequences of the study
- Able and willing to give written informed consent prior to study entry
- Available for all the visits scheduled in the study
- in good health as determined by:
- Medical history related to the previous six months,
- Physical examination,
- Clinical judgment of the investigator.
Who cannot join
- Unwilling or unable to give written informed consent to participate in the study
- Currently experiencing an acute infectious disease
- Any serious disease such as, for example:
- Cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy)
- Autoimmune disease (including rheumatoid arthritis)
- Advanced arteriosclerotic disease or complicated diabetes mellitus
Show all 26Show fewer
- Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy
- Acute or progressive hepatic disease
- Acute or progressive renal disease
- Congestive heart failure
- Surgery planned during the study period
- Bleeding diathesis
- History of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Known or suspected impairment/alteration of immune function resulting from:
- Receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy)
- 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
- High risk for developing an immunocompromising disease
- History of drug or alcohol abuse
- Laboratory confirmed influenza disease in the past 6 months
- Received influenza vaccine within the past 6 months
- Received another vaccine or any investigational agent within the past 60 days, or expect to receive another vaccine within 3 weeks following the study vaccination
- Participation in another clinical trial within 90 days prior to enrollment and throughout the full length of the study
- Any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever _ 38°C within the past 5 days
- Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
NZOZ Jagiello_skie
Centrum Medyczne Sp. Z O.o., O_. Jagiello_skie 1, Kraków, 31-832
NZOZ Praktyka Grupowa Lekarzy Rodzinnych, "Familia" Sp. z o.o.
Pl. Sikorskiego 6a, Kraków, 31-115
Wojewódzki Szpital Dzieci_cy
Ul. Langiewicza 2, Kielce, 25-381
Szpital Jana Pawła II, Oddz. Neuroinfekcji
Ul. Pr_dnicka 80, Kraków, 31-202
Centrum Bada_ Farmakologii Klinicznej
Ul. Ujastek 3, Krakow, 30-969
About this study
Official title: A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity (in a Subset) Following a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects Who Received Either One or the Other Vaccine One Year Before in the V58P4 Study.
The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.
- Conditions
- Influenza
- Being tested
- Cell culture derived influenza vaccine, egg-derived influenza subunit vaccine
- Keywords
- Influenza, adult/elderly, flu cell culture, 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.
Cell culture derived influenza vaccineBiological
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
egg-derived influenza subunit vaccineBiological
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
| Study group | Role | What they receive |
|---|---|---|
| cTIV\cTIV (adults) | Active comparator | Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study. Receives: Biological: Cell culture derived influenza vaccine |
| cTIV\TIV (adults) | Active comparator | Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. Receives: Biological: egg-derived influenza subunit vaccine |
| cTIV\cTIV (elderly) | Active comparator | Subjects (≥61 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study. Receives: Biological: Cell culture derived influenza vaccine |
| cTIV\TIV (elderly) | Active comparator | Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. Receives: Biological: egg-derived influenza subunit vaccine |
| TIV\TIV (adults) | Active comparator | Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. Receives: Biological: egg-derived influenza subunit vaccine |
| TIV\cTIV (adults) | Active comparator | Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. Receives: Biological: Cell culture derived influenza vaccine |
| TIV\TIV (elderly) | Active comparator | Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. Receives: Biological: egg-derived influenza subunit vaccine |
| TIV\cTIV (elderly) | Active comparator | Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. Receives: Biological: Cell culture derived influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine
To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .
Measured: Day 1 to Day 7 postvaccination
Secondary outcomes (5)
Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study.
Measured: Up to 6 months postvaccination
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects
The haemagglutinin inhibition (HI) antibody titer response following one 0.5 mL dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as GMTs.
The HI GMTs were evaluated using egg-derived antigen assay.
Measured: Day 22 postvaccination
Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects
Immunogenicity was assessed in terms of GMR in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria.
The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects.
Measured: Day 22 postvaccination
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.
Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine.
European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is > 70% for adults and >60% for elderly.
Measured: Day 22 postvaccination
Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived influenza vaccine.
Seroconversion or significant increase as per European Licensure (CHMP) criteria is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥ 40 for adults and ≥ 30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥ 10 and a ≥ 4-fold increase in postvaccination HI antibody titer.
Measured: Day 22 postvaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startSep 2005
- Primary completionDec 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines and Diagnostics S.r.l.
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines and Diagnostics, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306527
- Sponsor's protocol ID
- V58P4E1
- Other IDs
- EUDRACT: 2005-001902-26
- Status last verified
- Aug 2019
- First submitted
- 22 Mar 2006
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Casula D, Sparacio M, Kovacs C, Groth N. Safety assessment and immunogenicity of a cell-culture-derived influenza vaccine in adults and elderly subjects over three successive influenza seasons. Hum Vaccin Immunother. 2012 May;8(5):645-52. doi: 10.4161/hv.19493. Epub 2012 May 1.
PubMed 22418809
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity (in a Subset) Following a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects Who Received Either One or the Other Vaccine One Year Before in the V58P4 Study.
- ClinicalTrials.gov ID
- NCT00306527
- Acronym / sponsor ID
- V58P4E1
- Conditions
- Influenza
- Keywords
- Influenza, adult/elderly, flu cell culture, vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,235 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines and Diagnostics S.r.l.
- Study start
- Sep 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 24 Mar 2006 (estimated)
- Results
- Posted 11 Jan 2013
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 the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| cTIV\cTIV (adults) | Active comparator | Biological: Cell culture derived influenza vaccineSubjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study. |
| cTIV\TIV (adults) | Active comparator | Biological: egg-derived influenza subunit vaccineSubjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| cTIV\cTIV (elderly) | Active comparator | Biological: Cell culture derived influenza vaccineSubjects (≥61 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study. |
| cTIV\TIV (elderly) | Active comparator | Biological: egg-derived influenza subunit vaccineSubjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| TIV\TIV (adults) | Active comparator | Biological: egg-derived influenza subunit vaccineSubjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| TIV\cTIV (adults) | Active comparator | Biological: Cell culture derived influenza vaccineSubjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. |
| TIV\TIV (elderly) | Active comparator | Biological: egg-derived influenza subunit vaccineSubjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| TIV\cTIV (elderly) | Active comparator | Biological: Cell culture derived influenza vaccineSubjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 to < 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
- Mentally competent to understand the nature, the scope and the consequences of the study
- Able and willing to give written informed consent prior to study entry
- Available for all the visits scheduled in the study
- in good health as determined by:
Key exclusion criteria (26 listed)
- Unwilling or unable to give written informed consent to participate in the study
- Currently experiencing an acute infectious disease
- Any serious disease such as, for example:
- Surgery planned during the study period
- Bleeding diathesis
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 |
|---|---|---|
| Cell culture derived influenza vaccineas a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm | Biological | TIV\cTIV (adults), TIV\cTIV (elderly), cTIV\cTIV (adults), cTIV\cTIV (elderly) |
| egg-derived influenza subunit vaccineas a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm | Biological | TIV\TIV (adults), TIV\TIV (elderly), cTIV\TIV (adults), cTIV\TIV (elderly) |
Primary outcome
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine
Time frame: Day 1 to Day 7 postvaccination
To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .
5 secondary outcomes
Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
Time frame: Up to 6 months postvaccination
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects
Time frame: Day 22 postvaccination
Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects
Time frame: Day 22 postvaccination
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.
Time frame: Day 22 postvaccination
Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
Time frame: Day 22 postvaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22418809Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Casula D, Sparacio M, Kovacs C, Groth N. Safety assessment and immunogenicity of a cell-culture-derived influenza vaccine in adults and elderly subjects over three successive influenza seasons. Hum Vaccin Immunother. 2012 May;8(5):645-52. doi: 10.4161/hv.19493. Epub 2012 May 1.
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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 and Diagnostics study chair
Novartis Vaccines
5 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 Cell culture derived influenza vaccine and egg-derived influenza subunit vaccine in people with Influenza, run by Novartis Vaccines at 5 sites in Poland.
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 8 inclusion and 26 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. 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?
Yes. Results are posted in the registry (first posted 11 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine (time frame: Day 1 to Day 7 postvaccination). 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 NCT00306527, 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 14 Aug 2019.