Influenza, HumanPhase 4NCT01863433

A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers

A Phase 4 study testing Trivalent Influenza Vaccine in people with Influenza, Human, 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

This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged between 18 and 60 years. Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: Trivalent Influenza Vaccine
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 2013to Jun 2013
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 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males or females aged between 18 and 60 years at the time of vaccination.
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. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Who cannot join

Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
Clinical signs of an active infection.
A clinically significant medical condition.
Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
Females who are pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study Site
London, NW10 7EW

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 2013/2014 Formulation of a bioCSL Split Virion, Inactivated Influenza Vaccine in Healthy Volunteers Aged 18-60 Years

Conditions: Influenza, Human
Being tested: Trivalent 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.

Trivalent Influenza VaccineBiological

Study groups in NCT01863433
Study group	Role	What they receive
Trivalent Influenza Vaccine	Experimental	The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2013/2014 influenza season). The vaccine will be administered by intramuscular or deep subcutaneous injection. Receives: Biological: Trivalent Influenza Vaccine

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 (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) 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 (H1N1, H3N2, and B influenza virus strains) 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.
For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.
Measured: Approximately 21 days after vaccination

Secondary outcomes (2)

Type and Frequency of Any Solicited Adverse Events (AEs)
The percentage of participants reporting any solicited AEs.
Measured: During the 4 days after vaccination (Day 0 plus 3 days)
Type and Frequency of Any Unsolicited AEs
The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.
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 2013Jun 2013

First posted29 May 2013 (estimated)
Study startMay 2013
Primary completionJun 2013
Study completionJun 2013

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 Influenza, HumanStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01863433
Sponsor's protocol ID: CSLCT-TIV-13-84
Other IDs: 2013-001420-19
Status last verified: Apr 2018
First submitted: 23 May 2013
Last updated: 28 Jun 2018
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 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 2013/2014 Formulation of a bioCSL Split Virion, Inactivated Influenza Vaccine in Healthy Volunteers Aged 18-60 Years
ClinicalTrials.gov ID: NCT01863433
Acronym / sponsor ID: CSLCT-TIV-13-84
Conditions: Influenza, Human
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 29 May 2013 (estimated)
Results: Posted 15 Jan 2014

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Trivalent Influenza Vaccine	Experimental	Biological: Trivalent Influenza VaccineThe study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2013/2014 influenza season). The vaccine will be administered by intramuscular or deep subcutaneous injection.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Males or females aged between 18 and 60 years at the time of vaccination.
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. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Key exclusion criteria (5 listed)

Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
Clinical signs of an active infection.
A clinically significant medical condition.
Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
Females who are pregnant or lactating.

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
Trivalent Influenza Vaccine	Biological	Trivalent Influenza Vaccine

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 (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) 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 (H1N1, H3N2, and B influenza virus strains) 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
For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.

2 secondary outcomes

Type and Frequency of Any Solicited Adverse Events (AEs)
Time frame: During the 4 days after vaccination (Day 0 plus 3 days)
Type and Frequency of Any Unsolicited AEs
Time frame: After vaccination until the end of the study; approximately 21 days.

Results and safety

Results posted to the registry on 15 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trivalent Influenza Vaccine	120	119

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	Trivalent Influenza Vaccine n = 119
H1N1 strain	79 (70.6 to 85.9)
H3N2 strain	79 (70.6 to 85.9)
B strain	64.7 (55.4 to 73.2)

Population analysed: The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.

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

Time frame: Approximately 21 days after vaccination. Geometric mean (Standard Deviation). Unit: fold increase

Measure	Trivalent Influenza Vaccine n = 119
H1N1 strain	15.01 (4.27)
H3N2 strain	13.18 (4.494)
B strain	5.86 (3.461)

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	Trivalent Influenza Vaccine n = 119
H1N1 strain	97.5 (92.8 to 99.5)
H3N2 strain	99.2 (95.4 to 100.0)
B strain	95.0 (89.3 to 98.1)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: For solicited AEs: During the 4 days after vaccination (Day 0 plus 3 days); For unsolicited AEs and serious AEs (SAEs): After vaccination until the end of the study (approximately 21 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trivalent Influenza Vaccine	0 of 120 (0%)	81 of 120 (67.5%)	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.

bioCSL Head of Clinical Operations 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 Trivalent Influenza Vaccine in people with Influenza, Human, 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 2 inclusion and 5 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 15 Jan 2014). 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 NCT01863433.

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.