InfluenzaPhase 3NCT01412281

Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers

A Phase 3 study testing Virosomal influenza vaccine (AdImmune HA Antigen) and Virosomal influenza vaccine (CSL HA Antigen) 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.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly adults, using the EMA (European Medicines… 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?: Virosomal influenza vaccine (AdImmune HA Antigen) and Virosomal influenza vaccine (CSL HA Antigen)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 440 participants
Where: 1 siteSwitzerland
Study dates: Oct 2011to Dec 2011
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 years on Day 1
Written informed consent

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 (including the H1N1 pandemic swine flu 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, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
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 spouse and children of the investigator, or relative living in the same household as the investigator and/or are dependent on the investigator
Suspected non-compliance

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: Randomized, Parallel-group, Double-blind, Single-center Phase III Study to Assess the Immunogenicity and Safety of the 2011/2012-season Influenza Vaccine Formulated With HA Antigen From Two Suppliers, in Elderly and Young Adult Subjects Using the Current EMA Regulations as Guideline

Conditions: Influenza
Being tested: Virosomal influenza vaccine (AdImmune HA Antigen), Virosomal influenza vaccine (CSL HA Antigen)
Keywords: Influenza, Virus, Vaccination, Immunisation
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.

Virosomal influenza vaccine (AdImmune HA Antigen)Biological
Virosomal influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA Antigen) 2011/2012, with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus
Virosomal influenza vaccine (CSL HA Antigen)Biological
Virosomal influenza vaccine (surface antigen, inactivated, virosome, using CSL HA antigen) 2011/2012 with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Study groups in NCT01412281
Study group	Role	What they receive
Group A - Young adults	Experimental	1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012 Receives: Biological: Virosomal influenza vaccine (AdImmune HA Antigen)
Group B - Young adults	Active comparator	1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012 Receives: Biological: Virosomal influenza vaccine (CSL HA Antigen)
Group C - Elderly	Experimental	1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012 Receives: Biological: Virosomal influenza vaccine (AdImmune HA Antigen)
Group D - Elderly	Active comparator	1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012 Receives: Biological: Virosomal influenza vaccine (CSL HA Antigen)

What is being measured

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

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: 3 weeks after vaccination (Day 22 ± 2 days)
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: 3 weeks after vaccination (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: 3 weeks after vaccination (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, Tolerability and acceptability
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.

Oct 2011Dec 2011

First posted9 Aug 2011 (estimated)
Study startOct 2011
Primary completionDec 2011
Study completionDec 2011

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 440 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01412281
Sponsor's protocol ID: ADD-V-A002
Status last verified: Aug 2013
First submitted: 8 Aug 2011
Last updated: 9 Sep 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

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Parallel-group, Double-blind, Single-center Phase III Study to Assess the Immunogenicity and Safety of the 2011/2012-season Influenza Vaccine Formulated With HA Antigen From Two Suppliers, in Elderly and Young Adult Subjects Using the Current EMA Regulations as Guideline
ClinicalTrials.gov ID: NCT01412281
Acronym / sponsor ID: ADD-V-A002
Conditions: Influenza
Keywords: Influenza, Virus, Vaccination, Immunisation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 440 participants (actual)
Lead sponsor: Crucell Holland BVIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 9 Aug 2011 (estimated)
Results: Posted 22 Mar 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: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Group A - Young adults	Experimental	Biological: Virosomal influenza vaccine (AdImmune HA Antigen)1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012
Group B - Young adults	Active comparator	Biological: Virosomal influenza vaccine (CSL HA Antigen)1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012
Group C - Elderly	Experimental	Biological: Virosomal influenza vaccine (AdImmune HA Antigen)1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012
Group D - Elderly	Active comparator	Biological: Virosomal influenza vaccine (CSL HA Antigen)1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012

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 years on Day 1
Written informed consent

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 (including the H1N1 pandemic swine flu 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
Virosomal influenza vaccine (AdImmune HA Antigen)Virosomal influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA Antigen) 2011/2012, with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus	Biological	Group A - Young adults, Group C - Elderly
Virosomal influenza vaccine (CSL HA Antigen)Virosomal influenza vaccine (surface antigen, inactivated, virosome, using CSL HA antigen) 2011/2012 with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus	Biological	Group B - Young adults, Group D - Elderly

Primary outcome

Geometric Mean Titer
Time frame: 3 weeks after vaccination (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)
Seroprotection
Time frame: 3 weeks after vaccination (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: 3 weeks after vaccination (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)

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 22 Mar 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
≥18 to ≤60 Years - AdImmune HA Antigen	110	110
≥18 to ≤60 Years - CSL HA Antigen	110	110
>60 Years - AdImmune HA Antigen	110	110
>60 Years - CSL HA Antigen	110	110

Primary outcome: Geometric Mean Titer

Time frame: 3 weeks after vaccination (Day 22 ± 2 days). Number (95% Confidence Interval). Unit: GMT fold increase from baseline

Measure	≥18 to ≤60 Years - AdImmune HA Antigen n = 110	≥18 to ≤60 Years - CSL HA Antigen n = 110	>60 Years - AdImmune HA Antigen n = 110	>60 Years - CSL HA Antigen n = 110
GMT fold increase: A/H1N1	3.36 (2.78 to 4.07)	2.61 (2.21 to 3.09)	2.46 (2.11 to 2.87)	2.41 (2.04 to 2.85)
GMT fold increase: A/H3N2	2.01 (1.67 to 2.41)	2.04 (1.76 to 2.36)	1.65 (1.43 to 1.89)	1.99 (1.70 to 2.33)
GMT fold increase: B-strain	1.75 (1.54 to 1.99)	1.72 (1.53 to 1.95)	1.47 (1.33 to 1.62)	1.32 (1.21 to 1.44)

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

Primary outcome: Seroprotection

Time frame: 3 weeks after vaccination (Day 22 ± 2 days). Number (95% Confidence Interval). Unit: percentage of seroprotected subjects

Measure	≥18 to ≤60 Years - AdImmune HA Antigen n = 110	≥18 to ≤60 Years - CSL HA Antigen n = 110	>60 Years - AdImmune HA Antigen n = 110	>60 Years - CSL HA Antigen n = 110
Percentage seroprotected subjects: A/H1N1	99.1 (95.0 to 100)	100 (96.7 to 100)	96.4 (91.0 to 99.0)	97.3 (92.2 to 99.4)
Percentage seroprotected subjects: A/H3N2	100 (96.7 to 100)	99.1 (95.0 to 100)	99.1 (95.0 to 100)	100 (96.7 to 100)
Percentage seroprotected subjects: B-strain	98.2 (93.6 to 99.8)	100 (96.7 to 100)	97.3 (92.2 to 99.4)	95.5 (89.7 to 98.5)

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

Primary outcome: Seroconversion

Time frame: 3 weeks after vaccination (Day 22 ± 2 days). Number (95% Confidence Interval). Unit: percentage of seroconverted subjects

Measure	≥18 to ≤60 Years - AdImmune HA Antigen n = 110	≥18 to ≤60 Years - CSL HA Antigen n = 110	>60 Years - AdImmune HA Antigen n = 110	>60 Years - CSL HA Antigen n = 110
Percentage seroconverted subjects: A/H1N1	43.6 (34.2 to 53.4)	36.4 (27.4 to 46.1)	23.6 (16.1 to 32.7)	30.9 (22.4 to 40.4)
Percentage seroconverted subjects: A/H3N2	23.6 (16.1 to 32.7)	20.0 (13.0 to 28.7)	16.4 (10.0 to 24.6)	26.4 (18.4 to 35.6)
Percentage seroconverted subjects: B-strain	19.1 (12.2 to 27.7)	17.3 (10.7 to 25.7)	8.2 (3.8 to 15.0)	4.5 (1.5 to 10.3)

Population analysed: Intent-to-treat population, 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
≥18 to ≤60 Years - AdImmune HA Antigen	0 of 110 (0%)	60 of 110 (54.5%)	Not reported
≥18 to ≤60 Years - CSL HA Antigen	0 of 110 (0%)	52 of 110 (47.3%)	Not reported
>60 Years - AdImmune HA Antigen	0 of 110 (0%)	33 of 110 (30%)	Not reported
>60 Years - CSL HA Antigen	1 of 110 (0.9%)	29 of 110 (26.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Influenza

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

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?

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 9 Sep 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 22 Mar 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 Titer (time frame: 3 weeks after vaccination (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 NCT01412281.

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 9 Sep 2013.