Seasonal Influenza VaccinePhase 3NCT00511914

Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008

A Phase 3 study testing cTIV in people with Seasonal Influenza Vaccine, run by Novartis Vaccines at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Annual trial for registration of sub-unit influenza vaccine produced in mammalian cell culture, using the strain composition 2007/2008, when administered to adult and elderly subjects 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 Vaccine
What is being tested?: cTIV
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 135 participants
Where: 2 sitesGermany
Study dates: Jul 2007to Aug 2007
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

Subjects eligible for enrollment into this study are male and female adults who were:
≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
available for all the visits scheduled in the study and able to comply with all study requirements
in good health as determined by:
medical history
physical examination
clinical judgment of the investigator Written informed consent had to be obtained from all the subjects before enrollment in the study after the nature of the study had been explained.

Who cannot join

Subjects were not to be enrolled into the study if at least one of the following criteria was fulfilled:
Any serious chronic or acute disease such as:
Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy
Congestive heart failure
Advanced arteriosclerotic disease
Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days.

Show all 26Show fewer

Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below)
Insulin dependent diabetes mellitus
Acute or progressive hepatic disease
Acute or progressive renal disease
Severe neurological or psychiatric disorder
History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine or chemically related substances
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 (chronic therapy with immunosuppressive drugs, any parenteral or oral corticosteroid (substitution dose in case of absence of suprarenal function allowed) or cancer chemotherapy/radiotherapy) within the last 2 months 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
Bleeding diathesis or receive anticoagulants of the coumarin type
Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days)
Influenza immunization or laboratory confirmed influenza within the last 6 months and more than one influenza immunization within the past 12 months
Immunization with any other vaccine and/or any investigational vaccine four weeks prior to study start
Any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days
Fever (i.e. body temperature ≥ 38.0°C) within the past 3 days prior to study entry
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.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Betriebsaerztlicher Dienst, Standort Marburg
Baldingerstrasse, Marburg Hessen, 35033
Z29, Blutspendezentrale, Gebaude Z29, Behringwerke
Emil-von-Behring-Str. 76, Marburg, 35041

Other trials in Germany

About this study

Official title: A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture, Using the Strain Composition 2007/2008, When Administered to Adult and Elderly Subjects

Annual trial for registration of sub-unit influenza vaccine produced in mammalian cell culture, using the strain composition 2007/2008, when administered to adult and elderly subjects

Conditions: Seasonal Influenza Vaccine
Being tested: cTIV
Keywords: 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.

cTIVBiological
One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle

Study groups in NCT00511914
Study group	Role	What they receive
cTIV (Adults)	Experimental	Received one dose of cell-culture derived trivalent influenza vaccine (cTIV). Receives: Biological: cTIV
cTIV (Elderly)	Experimental	Received one dose of cell-culture derived trivalent influenza vaccine (cTIV). Receives: Biological: cTIV

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).
Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.
Measured: 3 weeks postvaccination (Day 22)
Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects.
The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects.
Measured: 3 weeks postvaccination (Day 22)
Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).
HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.
This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70% for adults and >60% for elderly subjects.
Measured: 3 weeks postvaccination (Day 22)
Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).
Proportion of subjects with either seroconversion (antibody increase from < 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination).
According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be >40% for adults and >30% for elderly subjects.
Measured: 3 weeks postvaccination (Day 22)

Secondary outcomes (1)

Number of Subjects Reporting Local and Systemic Reactions
To evaluate the safety and tolerability of cell culture derived vaccine (cTIV) in adults and elderly subjects in terms of number of subjects reporting local and systemic reactions after 1 vaccine dose.
Measured: 3 days postvaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Aug 2007

First posted6 Aug 2007 (estimated)
Study startJul 2007
Primary completionAug 2007
Study completionAug 2007

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.
Other trials for Seasonal Influenza VaccineStudies 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: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00511914
Sponsor's protocol ID: V58P1S
Other IDs: 2007-001404-20
Status last verified: Jan 2013
First submitted: 3 Aug 2007
Last updated: 24 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Seasonal Influenza Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2013. 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 Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture, Using the Strain Composition 2007/2008, When Administered to Adult and Elderly Subjects
ClinicalTrials.gov ID: NCT00511914
Acronym / sponsor ID: V58P1S
Conditions: Seasonal Influenza Vaccine
Keywords: Influenza vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Aug 2007 (actual)
Study completion: Aug 2007 (actual)
First posted: 6 Aug 2007 (estimated)
Results: Posted 17 Jan 2013

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 of sub-unit influenza vaccine produced in mammalian cell culture, using the strain composition 2007/2008, when administered to adult and elderly subjects

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
cTIV (Adults)	Experimental	Biological: cTIVReceived one dose of cell-culture derived trivalent influenza vaccine (cTIV).
cTIV (Elderly)	Experimental	Biological: cTIVReceived one dose of cell-culture derived trivalent influenza vaccine (cTIV).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
available for all the visits scheduled in the study and able to comply with all study requirements
in good health as determined by:

Key exclusion criteria (26 listed)

Subjects were not to be enrolled into the study if at least one of the following criteria was fulfilled:
Any serious chronic or acute disease such as:
History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine or chemically related substances
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
cTIVOne dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle	Biological	cTIV (Adults), cTIV (Elderly)

Primary outcome

Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).
Time frame: 3 weeks postvaccination (Day 22)
Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.
Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)
Time frame: 3 weeks postvaccination (Day 22)
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects.
Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).
Time frame: 3 weeks postvaccination (Day 22)
HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects. This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70% for adults and >60% for elderly subjects.
Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).
Time frame: 3 weeks postvaccination (Day 22)
Proportion of subjects with either seroconversion (antibody increase from < 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination). According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be >40% for adults and >30% for elderly subjects.

1 secondary outcome

Number of Subjects Reporting Local and Systemic Reactions
Time frame: 3 days postvaccination

Results and safety

Results posted to the registry on 17 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
cTIV (Adults)	68	68
cTIV (Elderly)	67	67

Primary outcome: Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).

Time frame: 3 weeks postvaccination (Day 22). Geometric mean (95% Confidence Interval). Unit: Titer

Measure	cTIV (Adults) n = 68	cTIV (Elderly) n = 67
A/H1N1 Prevaccination (Day 1)	22 (14 to 33)	23 (17 to 31)
A/H1N1 Postvaccination (Day 22)	624 (442 to 881)	199 (150 to 264)
A/H3N2 Prevaccination (Day 1)	36 (24 to 56)	80 (53 to 122)
A/H3N2 Postvaccination (Day 22)	405 (299 to 547)	283 (205 to 390)
B Prevaccination (Day 1)	8.16 (6.43 to 10)	16 (12 to 21)
B Postvaccination (Day 22)	96 (66 to 139)	40 (30 to 53)

Population analysed: Analysis was done on per protocol set

Primary outcome: Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)

Time frame: 3 weeks postvaccination (Day 22). Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	cTIV (Adults) n = 68	cTIV (Elderly) n = 67
A/H1N1 (Day 22 / Day1)	29 (18 to 46)	8.74 (6.13 to 12)
A/H3N2 (Day 22 / Day1)	11 (7.27 to 17)	3.53 (2.47 to 5.06)
B (Day 22 / Day1)	12 (7.69 to 18)	2.51 (1.93 to 3.27)

Population analysed: Analysis was done on per protocol set

Primary outcome: Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).

Time frame: 3 weeks postvaccination (Day 22). Number (95% Confidence Interval). Unit: Percentages of Subjects

Measure	cTIV (Adults) n = 68	cTIV (Elderly) n = 67
A/H1N1 Prevaccination (Day 1)	35 (24 to 48)	37 (26 to 50)
A/H1N1 Postvaccination (Day 22)	96 (88 to 99)	96 (87 to 99)
A/H3N2 Prevaccination (Day 1)	51 (39 to 64)	72 (59 to 82)
A/H3N2 Postvaccination (Day 22)	97 (90 to 100)	96 (87 to 99)
B Prevaccination (Day 1)	13 (6 to 24)	28 (18 to 41)
B Postvaccination (Day 22)	79 (68 to 88)	66 (53 to 77)

Population analysed: Analysis was done on per protocol set

Primary outcome: Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).

Time frame: 3 weeks postvaccination (Day 22). Number (95% Confidence Interval). Unit: Percentages of Subjects

Measure	cTIV (Adults) n = 68	cTIV (Elderly) n = 67
A/H1N1	79 (68 to 88)	67 (55 to 78)
A/H3N2	72 (60 to 82)	40 (28 to 53)
B	65 (52 to 76)	25 (16 to 37)

Population analysed: Analysis was done on per protocol set

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
cTIV (Adults)	0 of 68 (0%)	40 of 68 (58.8%)	Not reported
cTIV (Elderly)	0 of 67 (0%)	21 of 67 (31.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Seasonal Influenza Vaccine

RecruitingPhase 1
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Active, not recruitingPhase 3
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RecruitingPhase 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 study chair

Novartis Vaccines

2 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 cTIV in people with Seasonal Influenza Vaccine, run by Novartis Vaccines at 2 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 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 17 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?

Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV). (time frame: 3 weeks postvaccination (Day 22)). The study lists 4 primary outcomes in all. 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 NCT00511914.

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 24 Jan 2013.