InfluenzaPhase 4NCT00888381

A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers

A Phase 4 study testing Inactivated Influenza Vaccine (2009 / 2010 formulation) in people with Influenza, run by Seqirus at 1 site in United Kingdom.

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 the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine. 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?: Inactivated Influenza Vaccine (2009 / 2010 formulation)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited Kingdom
Study dates: May 2009to May 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males or females aged ≥ 18 years at the time of providing informed consent
Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent
Willing and able to adhere to all protocol requirements
Able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress/discomfort
Females of child bearing potential (i.e. ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study

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 Enzira® vaccine
Clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°C) at study entry
A clinically significant medical or psychiatric condition
A confirmed or suspected immunosuppressive condition
History of seizures
History of Guillain-Barré Syndrome

Show all 16Show fewer

Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine in the 6 months preceding study entry
Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of Enzira® vaccine
Currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry
Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of Enzira® vaccine
Currently participating in another investigational study or recent study participation ending 3 months preceding administration of Enzira® vaccine
Currently receiving treatment with warfarin or other anticoagulants
Evidence or history of substance or alcohol abuse within the 12 months before study entry
Females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period
Females who are pregnant or lactating
Any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Chiltern (Early Phase) Limited. Ninewells Hospital and Medical School
Dundee, DD1 9SY

Other trials in United Kingdom

About this study

Official title: A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2009/2010 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged ≥ 18 to < 60 Years) and 'Older Adults' (Aged ≥ 60 Years).

The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.

Conditions: Influenza
Being tested: Inactivated Influenza Vaccine (2009 / 2010 formulation)
Medical subject headings: Influenza, Human

What participants receive

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

Inactivated Influenza Vaccine (2009 / 2010 formulation)Biological
Also called Enzira® vaccine (2009 / 2010 formulation)
A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.

Study groups in NCT00888381
Study group	Role	What they receive
Adults	Experimental	Healthy volunteers aged 18 to 59 years Receives: Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)
Older Adults	Experimental	Healthy volunteers aged 60 years or older Receives: Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)

What is being measured

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

The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.
Measured: Approximately 21 days after vaccination
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.
Measured: Approximately 21 days after vaccination
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
Measured: Approximately 21 days after vaccination

Secondary outcomes (3)

The Frequency of Any Solicited Local Reactions.
The number of participants reporting any solicited local reactions.
Measured: During the 4 days after vaccination (Day 0 plus 3 days)
The Frequency of Any Solicited Systemic Symptoms.
The number of participants reporting any solicited systemic symptoms.
Measured: During the 4 days after vaccination (Day 0 plus 3 days)
The Incidence of Any Unsolicited Adverse Events (AEs).
The number of participants reporting any unsolicited adverse events.
Unsolicited adverse event (UAE) grading:
Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities.
Measured: After vaccination until the end of the study; approximately 21 days

Timeline

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

May 2009May 2009

First posted27 Apr 2009 (estimated)
Study startMay 2009
Primary completionMay 2009
Study completionMay 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00888381
Sponsor's protocol ID: CSLCT-NHF-09-57
Other IDs: 2009-011450-18, 2009
Status last verified: Apr 2018
First submitted: 24 Apr 2009
Last updated: 28 Jun 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 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2009/2010 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged ≥ 18 to < 60 Years) and 'Older Adults' (Aged ≥ 60 Years).
ClinicalTrials.gov ID: NCT00888381
Acronym / sponsor ID: CSLCT-NHF-09-57
Conditions: Influenza
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 27 Apr 2009 (estimated)
Results: Posted 18 Jul 2012

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 the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.

Study design

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

Arm	Type	Receives
Adults	Experimental	Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)Healthy volunteers aged 18 to 59 years
Older Adults	Experimental	Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)Healthy volunteers aged 60 years or older

Who may qualify

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

Key inclusion criteria (5 listed)

Males or females aged ≥ 18 years at the time of providing informed consent
Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent
Willing and able to adhere to all protocol requirements
Able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress/discomfort
Females of child bearing potential (i.e. ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study

Key exclusion criteria (16 listed)

Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine
Clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°C) at study entry
A clinically significant medical or psychiatric condition
A confirmed or suspected immunosuppressive condition
History of seizures

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
Inactivated Influenza Vaccine (2009 / 2010 formulation)Also: Enzira® vaccine (2009 / 2010 formulation)A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.	Biological	Adults, Older Adults

Primary outcome

The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
Time frame: Approximately 21 days after vaccination
As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
Time frame: Approximately 21 days after vaccination
GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
Time frame: Approximately 21 days after vaccination

3 secondary outcomes

The Frequency of Any Solicited Local Reactions.
Time frame: During the 4 days after vaccination (Day 0 plus 3 days)
The Frequency of Any Solicited Systemic Symptoms.
Time frame: During the 4 days after vaccination (Day 0 plus 3 days)
The Incidence of Any Unsolicited Adverse Events (AEs).
Time frame: After vaccination until the end of the study; approximately 21 days

Results and safety

Results posted to the registry on 18 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adults	60	60
Older Adults	60	59

Primary outcome: The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.

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

Measure	Adults n = 60	Older Adults n = 58
A/Brisbane/59/2007 (H1N1) - like strain	91.7 (81.6 to 97.2)	53.4 (39.9 to 66.7)
A/Brisbane/10/2007 (H3N2) - like strain	93.3 (83.8 to 98.2)	63.8 (50.1 to 76.0)
B/Brisbane/60/2008 - like strain	76.7 (64.0 to 86.6)	46.6 (33.3 to 60.1)

Population analysed: The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).

Primary outcome: The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.

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

Measure	Adults n = 60	Older Adults n = 58
A/Brisbane/59/2007 (H1N1) - like strain	27.86 (19.339 to 40.129)	5.02 (3.575 to 7.048)
A/Brisbane/10/2007( H3N2) - like strain	30.32 (21.003 to 43.772)	9.80 (6.105 to 15.738)
B/Brisbane/60/2008 - like strain	12.85 (9.333 to 17.683)	6.13 (4.121 to 9.107)

Primary outcome: The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.

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

Measure	Adults n = 60	Older Adults n = 58
A/Brisbane/59/2007 (H1N1) - like strain	100.0 (94.0 to 100.0)	91.4 (81.0 to 97.1)
A/Brisbane/10/2007( H3N2) - like strain	100.0 (94.0 to 100.0)	94.8 (85.6 to 98.9)
B/Brisbane/60/2008 - like strain	85.0 (73.4 to 92.9)	60.3 (46.6 to 73.0)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adults	0 of 60 (0%)	14 of 60 (23.3%)	Not reported
Older Adults	0 of 60 (0%)	11 of 60 (18.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inactivated Influenza Vaccine (2009 / 2010 formulation) in people with Influenza, run by Seqirus at 1 site in United Kingdom.

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 5 inclusion and 16 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 28 Jun 2018. 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 United Kingdom. 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 Jul 2012). 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?

The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. (time frame: Approximately 21 days after vaccination). 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 NCT00888381.

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 28 Jun 2018.