InfluenzaPhase 3NCT01640314

Safety and Immunogenicity of a Cell Derived Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above

A Phase 3 study testing Cell derived subunit trivalent nonadjuvanted vaccine in people with Influenza, run by Novartis Vaccines at 1 site in Germany.

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Cell derived subunit trivalent nonadjuvanted vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteGermany
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

Male and female volunteers of 18 years of age or older;
Individuals able to comply with all the study requirements;
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Who cannot join

Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:
Medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years or localized prostate cancer that has been clinically stable for more than 2 years without treatment);
Medically significant advanced congestive heart failure (ie. NYHA class III and IV);
Chronic obstructive pulmonary disease (COPD; i.e., GOLD Stage III and IV);
Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for ≥5 years);

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Diabetes mellitus type I;
Poorly controlled diabetes mellitus type II;
Advanced arteriosclerotic disease;
History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down's syndrome);
Acute or progressive hepatic disease;
Acute or progressive renal disease;
Severe neurological (es. Guillain-Barré syndrome) or psychiatric disorder;
Severe asthma.
Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g.Influenza viral protein).
Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;
receipt of immunostimulants;
receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivatives within the past 3 months and for the full length of the study;
suspected or known HIV infection or HIV-related disease.
Individuals with known or suspected history of drug or alcohol abuse.
Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject.
Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.
Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study.
Individuals who within the past 6 months have:
had any laboratory confirmed seasonal or pandemic influenza disease;
received any seasonal or pandemic influenza vaccine.
Individuals who received any other vaccine within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine during the study.
Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.
Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
Individuals who are part of study personnel or close family members conducting this study.
BMI >35 kg/m2.
Females who are pregnant (confirmed by positive urine pregnancy test) or nursing (breastfeeding). Females of childbearing potential who refuse to use an acceptable method of birth control for the whole duration of the study.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Bernhard Nocht Institute
Bernhard-Nocht-Strasse 74, Free and Hanseatic City of Hamburg, D-20359

Other trials in Germany

About this study

Official title: A Phase 3 Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture (Optaflu®), Formulation 2012/2013, When Administered to Adult and Elderly Subjects

The purpose of this study is to evaluate the safety of a single intramuscular (IM) injection of the cell derived subunit trivalent nonadjuvanted influenza vaccine in adult and elderly subjects and the antibody response to each influenza vaccine antigen, as measured by hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

Conditions: Influenza
Being tested: Cell derived subunit trivalent nonadjuvanted vaccine
Keywords: Influenza, Adults, Elderly, Immunology, Safety
Medical subject headings: Influenza, Human

What participants receive

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

Cell derived subunit trivalent nonadjuvanted vaccineBiological
A single 0.5 mL dose of the cell derived subunit trivalent nonadjuvated influenza vaccine (TIVc) supplied in prefilled syringes and administered intramuscularly in the deltoid muscle (preferably) of the non dominant arm.

Study groups in NCT01640314
Study group	Role	What they receive
Cell derived subunit trivalent nonadjuvanted vaccine	Experimental	Not described Receives: Biological: Cell derived subunit trivalent nonadjuvanted vaccine

What is being measured

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

Percentages of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVc
Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI cell-derived antigen assay.
As per the European (CHMP) criteria, seroconversion or significant increase in titer is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. This criterion is met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is >40% (≥18 years to ≤60 years) or 30% (≥61 years).
Measured: Day 22
Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVc
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22).
The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years).
Measured: Day 22
Percentages of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVc
Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVc vaccination (day 22).
This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is >70% (≥18 years to ≤60) or 60% (≥61 years).
Measured: Day 1 and 22

Secondary outcomes (2)

Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after TIVc vaccination.
Measured: From day 1 through day 4 postvaccination
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc.
The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 22 after receiving one dose of TIVc.
Measured: Day 1 to Day 22

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 posted13 Jul 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01640314
Sponsor's protocol ID: V58_32S
Other IDs: 2011-006277-25
Status last verified: Jan 2016
First submitted: 6 Jul 2012
Last updated: 17 Feb 2016
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 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture (Optaflu®), Formulation 2012/2013, When Administered to Adult and Elderly Subjects
ClinicalTrials.gov ID: NCT01640314
Acronym / sponsor ID: V58_32S
Conditions: Influenza
Keywords: Influenza, Adults, Elderly, Immunology, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 13 Jul 2012 (estimated)
Results: Posted 27 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
Cell derived subunit trivalent nonadjuvanted vaccine	Experimental	Biological: Cell derived subunit trivalent nonadjuvanted vaccine

Who may qualify

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

Key inclusion criteria (3 listed)

Male and female volunteers of 18 years of age or older;
Individuals able to comply with all the study requirements;
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Key exclusion criteria (34 listed)

Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:
Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g.Influenza viral protein).
Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
Individuals with known or suspected history of drug or alcohol abuse.

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
Cell derived subunit trivalent nonadjuvanted vaccineA single 0.5 mL dose of the cell derived subunit trivalent nonadjuvated influenza vaccine (TIVc) supplied in prefilled syringes and administered intramuscularly in the deltoid muscle (preferably) of the non dominant arm.	Biological	Cell derived subunit trivalent nonadjuvanted vaccine

Primary outcome

Percentages of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVc
Time frame: Day 22
Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI cell-derived antigen assay. As per the European (CHMP) criteria, seroconversion or significant increase in titer is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. This criterion is met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is >40% (≥18 years to ≤60 years) or 30% (≥61 years).
Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVc
Time frame: Day 22
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22). The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years).
Percentages of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVc
Time frame: Day 1 and 22
Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVc vaccination (day 22). This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is >70% (≥18 years to ≤60) or 60% (≥61 years).

2 secondary outcomes

Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)
Time frame: From day 1 through day 4 postvaccination
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc.
Time frame: Day 1 to Day 22

Results and safety

Results posted to the registry on 27 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
18-60 Y	63	63
≥ 61 Y	63	62

Primary outcome: Percentages of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVc

Time frame: Day 22. Number (95% Confidence Interval). Unit: Percentages

Measure	18-60 Y n = 63	≥ 61 Y n = 62
A/H1N1	73 (60 to 83)	58 (45 to 70)
A/H3N2	67 (54 to 78)	45 (32 to 58)
B	63 (50 to 75)	42 (30 to 55)

Population analysed: Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.

Primary outcome: Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVc

Time frame: Day 22. Number (95% Confidence Interval). Unit: Ratio

Measure	18-60 Y n = 63	≥ 61 Y n = 62
A/H1N1	13 (8.75 to 20)	5.79 (4.12 to 8.12)
A/H3N2	6.38 (4.5 to 9.06)	4.21 (2.96 to 5.97)
B	5.63 (4.11 to 7.7)	3.54 (2.65 to 4.72)

Population analysed: Analysis was done on the PP set.

Primary outcome: Percentages of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVc

Time frame: Day 1 and 22. Number (95% Confidence Interval). Unit: Percentages

Measure	18-60 Y n = 63	≥ 61 Y n = 62
A/H1N1 (Day 1)	56 (42 to 68)	61 (48 to 73)
A/H1N1 (Day 22)	98 (91 to 100)	100 (94 to 100)
A/H3N2 (Day 1)	86 (75 to 93)	85 (74 to 93)
A/H3N2 (Day 22)	100 (94 to 100)	100 (94 to 100)
B (Day 1)	54 (41 to 67)	40 (28 to 54)
B (Day 22)	98 (91 to 100)	85 (74 to 93)

Population analysed: Analysis was done on the PP set.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day 1 through day 22. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
18-60 Y	0 of 63 (0%)	45 of 63 (71.4%)	Not reported
≥ 61 Y	0 of 63 (0%)	30 of 63 (47.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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.

Novartis Vaccines and Diagnostics study chair

Novartis Vaccines

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 Cell derived subunit trivalent nonadjuvanted vaccine in people with Influenza, run by Novartis Vaccines at 1 site in Germany.

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 34 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 17 Feb 2016. 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 Germany. 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 27 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?

Percentages of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVc (time frame: Day 22). 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 NCT01640314.

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 17 Feb 2016.