InfluenzaPhase 3NCT01631110

Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains

A Phase 3 study testing Inflexal V in people with Influenza, run by Crucell Holland BV at 1 site in Switzerland.

Completed

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

Trial summary

The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines. 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?: Inflexal V
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteSwitzerland
Study dates: Jul 2012to Aug 2012
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

Healthy female and male adults aged ≥18 on Day 1
Written informed consent
Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

Who cannot join

Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
Acute febrile illness (≥38.0 °C)
Prior vaccination with an influenza vaccine in the past 330 days
Known hypersensitivity to any vaccine component
Previous history of a serious adverse reaction to influenza vaccine
History of egg protein allergy or severe atopy

Show all 15Show fewer

Known blood coagulation disorder
Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
Investigational medicinal product received in the past 3 months (90 days)
Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
Pregnancy or lactation
Participation in another clinical trial
Employee at the investigational site, or relative of the investigator
Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Covance Clinical Research Unit AG
Allschwil, 4123

Other trials in Switzerland

About this study

Official title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2012/2013-Season Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations

The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.

Conditions: Influenza
Being tested: Inflexal V
Keywords: Influenza, Virus, Vaccination, Inflexal V
Medical subject headings: Influenza, Human, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inflexal VBiological
Also called Inflexal V influenza vaccine (surface antigen, inactivated, virosome) formulated for the WHO requirements of the 2012-2013 season, each 0.5 mL dose containing:, • 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus, • 15 µg HA antigen of A/Victoria/361/2011 (H3N2)-like virus, • 15 µg HA antigen of B/Wisconsin/1/2010-like virus
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V

Study groups in NCT01631110
Study group	Role	What they receive
Elderly subjects aged over 60 years	Experimental	Not described Receives: Biological: Inflexal V
Adults from 18 to 60 years old inclusive	Experimental	Not described Receives: Biological: Inflexal V

What is being measured

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

Seroprotection
Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Measured: Day 22 +/- 2 days
Seroconversion
Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Measured: Day 22 +/- 2 days
Geometric Mean Titer
GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Measured: Day 22 +/- 2 days

Secondary outcomes (1)

Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
Solicited local and systemic AEs, Unsolicited AEs
Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).
Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4
Measured: Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)

Timeline

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

Jul 2012Aug 2012

First posted28 Jun 2012 (estimated)
Study startJul 2012
Primary completionAug 2012
Study completionAug 2012

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 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: Parallel groups
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01631110
Sponsor's protocol ID: INF-V-A010
Status last verified: Aug 2013
First submitted: 25 Jun 2012
Last updated: 20 Dec 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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Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2012/2013-Season Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations
ClinicalTrials.gov ID: NCT01631110
Acronym / sponsor ID: INF-V-A010
Conditions: Influenza
Keywords: Influenza, Virus, Vaccination, Inflexal V
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Crucell Holland BVIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 28 Jun 2012 (estimated)
Results: Posted 20 Dec 2013

Clinical summary

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

The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Elderly subjects aged over 60 years	Experimental	Biological: Inflexal V
Adults from 18 to 60 years old inclusive	Experimental	Biological: Inflexal V

Who may qualify

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

Key inclusion criteria (3 listed)

Healthy female and male adults aged ≥18 on Day 1
Written informed consent
Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

Key exclusion criteria (15 listed)

Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
Acute febrile illness (≥38.0 °C)
Prior vaccination with an influenza vaccine in the past 330 days
Known hypersensitivity to any vaccine component
Previous history of a serious adverse reaction to influenza vaccine

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
Inflexal VAlso: Inflexal V influenza vaccine (surface antigen, inactivated, virosome) formulated for the WHO requirements of the 2012-2013 season, each 0.5 mL dose containing:, • 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus, • 15 µg HA antigen of A/Victoria/361/2011 (H3N2)-like virus, • 15 µg HA antigen of B/Wisconsin/1/2010-like virusIntramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V	Biological	Adults from 18 to 60 years old inclusive, Elderly subjects aged over 60 years

Primary outcome

Seroprotection
Time frame: Day 22 +/- 2 days
Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Seroconversion
Time frame: Day 22 +/- 2 days
Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Geometric Mean Titer
Time frame: Day 22 +/- 2 days
GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

1 secondary outcome

Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
Time frame: Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)

Results and safety

Results posted to the registry on 20 Dec 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
Elderly Subjects Aged Over 60 Years	55	55
Adults From 18 to 60 Years Old Inclusive	55	55

Primary outcome: Seroprotection

Time frame: Day 22 +/- 2 days. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Elderly Subjects Aged Over 60 Years n = 55	Adults From 18 to 60 Years Old Inclusive n = 55
Percentage seroprotected subjects: A/H1N1	65.5 (51.4 to 77.8)	80.0 (67.0 to 89.6)
Percentage seroprotected subjects: A/H3N2	98.2 (90.3 to 100)	98.2 (90.3 to 100)
Percentage seroprotected subjects: B strain	52.7 (38.8 to 66.3)	70.9 (57.1 to 82.4)

Population analysed: Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers

Primary outcome: Seroconversion

Time frame: Day 22 +/- 2 days. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Elderly Subjects Aged Over 60 Years n = 55	Adults From 18 to 60 Years Old Inclusive n = 55
Percentage seroconverted subjects: A/H1N1	50.9 (37.1 to 64.6)	45.5 (32.0 to 59.4)
Percentage seroconverted subjects: A/H3N2	18.2 (9.1 to 30.9)	12.7 (5.3 to 24.5)
Percentage seroconverted subjects: B strain	25.5 (14.7 to 39.0)	41.8 (28.7 to 55.9)

Population analysed: Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers

Primary outcome: Geometric Mean Titer

Time frame: Day 22 +/- 2 days. Number (95% Confidence Interval). Unit: GMT fold increase from baseline

Measure	Elderly Subjects Aged Over 60 Years n = 55	Adults From 18 to 60 Years Old Inclusive n = 55
GMT fold increase: A/H1N1	5.15 (3.55 to 7.45)	4.36 (3.32 to 5.71)
GMT fold increase: A/H3N2	1.96 (1.64 to 2.35)	1.72 (1.49 to 1.99)
GMT fold increase: B strain	2.40 (1.97 to 2.92)	3.33 (2.55 to 4.36)

Population analysed: Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Elderly Subjects Aged Over 60 Years	0 of 55 (0%)	25 of 55 (45.5%)	Not reported
Adults From 18 to 60 Years Old Inclusive	0 of 55 (0%)	35 of 55 (63.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Michael Seiberling, MD principal investigator

Covance Clinical Research Unit AG

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 Inflexal V in people with Influenza, run by Crucell Holland BV at 1 site in Switzerland.

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 15 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 20 Dec 2013. 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 Switzerland. 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 20 Dec 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?

Seroprotection (time frame: Day 22 +/- 2 days). The study lists 3 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 NCT01631110.

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 20 Dec 2013.