InfluenzaPhase 4NCT00735475

A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine

A Phase 4 study testing CSL Limited Influenza Virus Vaccine (Afluria®) and US Licensed Influenza Virus Vaccine (Fluzone®) in people with Influenza, run by Seqirus at 13 sites in United States.

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

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: CSL Limited Influenza Virus Vaccine (Afluria®) and US Licensed Influenza Virus Vaccine (Fluzone®)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,268 participants
Where: 13 sitesUnited States
Study dates: Oct 2008to Jun 2009
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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
Written informed consent ;
Willingness to provide a blood sample.

Who cannot join

Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines;
Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine;
Known history of Guillain-Barré Syndrome;
Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C).
Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders;
History of seizures;

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Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder;
Clinically significant history of malignancy
Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine;
Current immunosuppressive or immunomodulative therapy;
Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine;
Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ;
Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine.
Current treatment with warfarin or other anticoagulants;
Major congenital defects;
Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards;
History of psychiatric disorders;
Resident of long term care facility.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Covance CRU Inc.
Austin, Texas, 78752
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004
Covance CRU, Inc
Boise, Idaho, 83704
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University Medical Center
Durham, North Carolina, 27704
The University of Iowa
Iowa City, Iowa, 52242
Clinical Partners, LLC
Johnston, Rhode Island, 02919
North Central Arkansas Medical Association
Mountain Home, Arkansas, 72635
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, 15241
Covance CRU, Inc.
Portland, Oregon, 97239
University of Rochester School of Medicine and Dentistry
Rochester, New York, 14642
Saint Louis University Medical Center
St Louis, Missouri, 63104

Other trials in United States

About this study

Official title: A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.

Conditions: Influenza
Being tested: CSL Limited Influenza Virus Vaccine (Afluria®), US Licensed Influenza Virus Vaccine (Fluzone®)
Medical subject headings: Influenza, Human

What participants receive

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

CSL Limited Influenza Virus Vaccine (Afluria®)Biological
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
US Licensed Influenza Virus Vaccine (Fluzone®)Biological
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.

Study groups in NCT00735475
Study group	Role	What they receive
Afluria®	Experimental	Not described Receives: Biological: CSL Limited Influenza Virus Vaccine (Afluria®)
Fluzone®	Active comparator	Not described Receives: Biological: US Licensed Influenza Virus Vaccine (Fluzone®)

What is being measured

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

Geometric Mean Titer 21 Days After the Study Vaccination
Measured: 21 days after vaccination
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination
Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Measured: 21 days after vaccination

Secondary outcomes (5)

Frequency and Intensity of Local and Systemic Solicited Symptoms
Measured: 5 days after vaccination
Duration of Local and Systemic Solicited Symptoms
Measured: 5 days after vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Abbreviation UAE stands for Unsolicited Adverse Event.
Measured: 21 days after vaccination
Serious Adverse Events
Measured: 180 days after vaccination
New Onsets of Chronic Illness
A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).
Measured: 180 days after vaccination

Timeline

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

Oct 2008Jun 2009

First posted15 Aug 2008 (estimated)
Study startOct 2008
Primary completionJan 2009
Study completionJun 2009

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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 1,268 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00735475
Sponsor's protocol ID: CSLCT-USF-07-41
Status last verified: Apr 2018
First submitted: 13 Aug 2008
Last updated: 23 May 2018
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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Study at a glance

From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years
ClinicalTrials.gov ID: NCT00735475
Acronym / sponsor ID: CSLCT-USF-07-41
Conditions: Influenza
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,268 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Jan 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 15 Aug 2008 (estimated)
Results: Posted 1 Sep 2011

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 this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Afluria®	Experimental	Biological: CSL Limited Influenza Virus Vaccine (Afluria®)
Fluzone®	Active comparator	Biological: US Licensed Influenza Virus Vaccine (Fluzone®)

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
Written informed consent ;
Willingness to provide a blood sample.

Key exclusion criteria (19 listed)

Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines;
Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine;
Known history of Guillain-Barré Syndrome;
Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C).
Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders;

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
CSL Limited Influenza Virus Vaccine (Afluria®)A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.	Biological	Afluria®
US Licensed Influenza Virus Vaccine (Fluzone®)A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.	Biological	Fluzone®

Primary outcome

Geometric Mean Titer 21 Days After the Study Vaccination
Time frame: 21 days after vaccination
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination
Time frame: 21 days after vaccination
Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.

5 secondary outcomes

Frequency and Intensity of Local and Systemic Solicited Symptoms
Time frame: 5 days after vaccination
Duration of Local and Systemic Solicited Symptoms
Time frame: 5 days after vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Time frame: 21 days after vaccination
Serious Adverse Events
Time frame: 180 days after vaccination
New Onsets of Chronic Illness
Time frame: 180 days after vaccination

Results and safety

Results posted to the registry on 1 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Afluria® Group	631	623
Fluzone® Group	637	626

Primary outcome: Geometric Mean Titer 21 Days After the Study Vaccination

Time frame: 21 days after vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Afluria® Group n = 622	Fluzone® Group n = 630
H1N1 (A/Brisbane/59/2007)	58.60 (53.35 to 64.37)	58.45 (53.23 to 64.17)
H3N2 (A/Uruguay/716/2007)	377.94 (339.31 to 420.97)	337.23 (302.99 to 375.34)
B (B/Florida/4/2006)	30.16 (27.70 to 32.84)	33.31 (30.54 to 36.33)

Population analysed: Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.

Primary outcome: Percentage of Participants With Seroconversion 21 Days After the Study Vaccination

Time frame: 21 days after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Afluria® Group n = 622	Fluzone® Group n = 630
H1N1 (A/Brisbane/59/2007)	38.6 (34.7 to 42.5)	43.2 (39.3 to 47.1)
H3N2 (A/Uruguay/716/2007)	69.0 (65.2 to 72.6)	68.7 (64.9 to 72.3)
B (B/Florida/4/2006)	28.9 (25.4 to 32.7)	33.8 (30.1 to 37.7)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afluria® Group	22 of 630 (3.5%)	142 of 630 (22.5%)	Not reported
Fluzone® Group	26 of 636 (4.1%)	119 of 636 (18.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
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.

Clinical Director Vaccines study director

Seqirus

13 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 CSL Limited Influenza Virus Vaccine (Afluria®) and US Licensed Influenza Virus Vaccine (Fluzone®) in people with Influenza, run by Seqirus at 13 sites in United States.

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 19 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 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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 1 Sep 2011). 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 21 Days After the Study Vaccination (time frame: 21 days after vaccination). The study lists 2 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 NCT00735475.

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 23 May 2018.