Seasonal InfluenzaPhase 4NCT00560066

Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

A Phase 4 study testing Cell-derived influenza vaccine and Egg-derived influenza vaccine in people with Seasonal Influenza and Vaccine, run by Novartis Vaccines at 15 sites in Germany.

Completed

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

Official record

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Trial summary

Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and without underlying medical conditions and evaluation of the immunogenicity in a subset of subjects with underlying medical conditions… 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?: Cell-derived influenza vaccine and Egg-derived influenza vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,398 participants
Where: 15 sitesGermany
Study dates: Nov 2007to Jul 2008
Phase: Phase 4
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 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
Able to comply with all study procedures and requirements.

Who cannot join

History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;
Fatal prognosis of an underlying medical condition (<12 months life expectancy);
History of Guillain-Barre syndrome;
Bleeding diathesis or receiving anticoagulants of the coumarin type;
Hospitalization or residence in a nursing care facility;
Planned to receive seasonal influenza vaccine outside of this study;

Show all 11Show fewer

Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study;
Fever (defined as axillary temperature ≥38.0°C) or any acute illness within 3 days prior to study vaccination;
Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end safety follow up period of the 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;
Females who were pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who were sexually active and had not used or did not plan to use acceptable birth control measures during the first 3 weeks after vaccination. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device were considered acceptable forms of birth control.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Germany15 sites

Study site
Balve
Study site
Duisberg
Study site
Garmisch-Partenkirchen
Study site
Hanover
Study site
Herborn
Study site
Illingen
Study site
Kiel
Study site
Laufach
Study site
Marburg
Study site
Midlum
Study site
Olpe
Study site
Potsdam
Study site
Regensburg
Study site
Unterschleissheim
Study site
Wiesbaden

Other trials in Germany

About this study

Official title: A Phase IV, Multi-Center, Active-Controlled, Observer-Blind Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture (Optaflu®) or in Embryonated Hen Eggs (Agrippal®) in Adults and Elderly With and Without Underlying Medical Conditions, and to Evaluate the Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

Conditions: Seasonal Influenza, Vaccine
Being tested: Cell-derived influenza vaccine, Egg-derived influenza vaccine
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.

Cell-derived influenza vaccineBiological
1 dose of 0.5 mL in the deltoid region of the non-dominant arm
Egg-derived influenza vaccineBiological
1 dose of 0.5 mL in the deltoid region of the non-dominant arm

Study groups in NCT00560066
Study group	Role	What they receive
cTIV	Experimental	Subjects received one vaccination of cell culture-derived influenza vaccine Receives: Biological: Cell-derived influenza vaccine
TIV	Active comparator	Subjects received one vaccination of egg-derived influenza vaccine Receives: Biological: Egg-derived influenza vaccine

What is being measured

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

Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV
Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.
Measured: From Day 1 up to and including Day 7 post-vaccination

Secondary outcomes (6)

Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV
Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).
Measured: From Day 1 through Day 7 post-vaccination
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV
Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.
Measured: From Day 1 through Day 7 post-vaccination
Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV
Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% (≥18 to ≤60 years), or >60% (≥61 years).
Measured: Before vaccination (Day 1) and three weeks after vaccination (Day 22)
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV
Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be >40% (≥18 to ≤60 years) or >30% (≥61 years).
Measured: Three weeks post-vaccination (Day 22)
Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).
Measured: Before vaccination (Day 1) and three weeks after vaccination (Day 22)
Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is >2.5 (≥18 to ≤60 years) or >2.0 (≥61 Years).
Measured: Three weeks post-vaccination (Day 22)

Timeline

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

Nov 2007Jul 2008

First posted19 Nov 2007 (estimated)
Study startNov 2007
Primary completionJul 2008
Study completionJul 2008

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 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 1,398 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00560066
Sponsor's protocol ID: V58P14
Other IDs: 2007-002872-32
Status last verified: Jan 2016
First submitted: 16 Nov 2007
Last updated: 17 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

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 trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Multi-Center, Active-Controlled, Observer-Blind Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture (Optaflu®) or in Embryonated Hen Eggs (Agrippal®) in Adults and Elderly With and Without Underlying Medical Conditions, and to Evaluate the Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
ClinicalTrials.gov ID: NCT00560066
Acronym / sponsor ID: V58P14
Conditions: Seasonal Influenza, Vaccine
Keywords: influenza, vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,398 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 19 Nov 2007 (estimated)
Results: Posted 18 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
cTIV	Experimental	Biological: Cell-derived influenza vaccineSubjects received one vaccination of cell culture-derived influenza vaccine
TIV	Active comparator	Biological: Egg-derived influenza vaccineSubjects received one vaccination of egg-derived influenza vaccine

Who may qualify

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

Key inclusion criteria (2 listed)

Subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
Able to comply with all study procedures and requirements.

Key exclusion criteria (11 listed)

History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;
Fatal prognosis of an underlying medical condition (<12 months life expectancy);
History of Guillain-Barre syndrome;
Bleeding diathesis or receiving anticoagulants of the coumarin type;
Hospitalization or residence in a nursing care facility;

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-derived influenza vaccine1 dose of 0.5 mL in the deltoid region of the non-dominant arm	Biological	cTIV
Egg-derived influenza vaccine1 dose of 0.5 mL in the deltoid region of the non-dominant arm	Biological	TIV

Primary outcome

Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV
Time frame: From Day 1 up to and including Day 7 post-vaccination
Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.

6 secondary outcomes

Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV
Time frame: From Day 1 through Day 7 post-vaccination
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV
Time frame: From Day 1 through Day 7 post-vaccination
Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV
Time frame: Before vaccination (Day 1) and three weeks after vaccination (Day 22)
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV
Time frame: Three weeks post-vaccination (Day 22)
Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
Time frame: Before vaccination (Day 1) and three weeks after vaccination (Day 22)
Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
Time frame: Three weeks post-vaccination (Day 22)

Results and safety

Results posted to the registry on 18 Apr 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
Egg-derived Vaccine (TIV)	396	390
Cell Culture-derived Vaccine (cTIV)	1,002	980

Primary outcome: Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV

Time frame: From Day 1 up to and including Day 7 post-vaccination. Number. Unit: Subjects

Measure	Egg-derived Vaccine (TIV) n = 396	Cell Culture-derived Vaccine (cTIV) n = 1001
Any reaction - Missing	1	2
Any reaction - None	204	488
Any reaction - Other than severe	186	495
Any reaction - Severe	5	16
Local reaction - Missing	5	17
Local reaction - None	274	654
Local reaction - Other than severe	117	325
Local reaction - Severe	0	5

Population analysed: Analysis was performed on the safety dataset, i.e. all subjects in the exposed set who provided post-baseline safety data.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study period (day 1 to day 181).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Egg-derived Vaccine (TIV)	10 of 396 (2.5%)	204 of 396 (51.5%)	Not reported
Cell Culture-derived Vaccine (cTIV)	20 of 1,001 (2%)	568 of 1,001 (56.7%)	Not reported

Limitations and caveats (from the sponsor): Because cTIV was not available, the second part of the study was not performed. In addition, as deviations from protocol procedures and GCP were identified at some sites, data collected for this study were not used to support licensure of cTIV.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 1
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Active, not recruitingPhase 3
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RecruitingPhase 1
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Not yet recruitingPhase 4
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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

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cell-derived influenza vaccine and Egg-derived influenza vaccine in people with Seasonal Influenza and Vaccine, run by Novartis Vaccines at 15 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 2 inclusion and 11 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 18 Apr 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 Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV (time frame: From Day 1 up to and including Day 7 post-vaccination). 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 NCT00560066.

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 17 Feb 2016.