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InfluenzaPhase 1NCT02126761

Safety and Immunogenicity of Different Formulations of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects 65 Years of Age and Above

A Phase 1 study testing Adjuvanted, trivalent subunit influenza vaccine, Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine and Antigen level modified adjuvanted, trivalent subunit influenza vaccine in people with Influenza, run by Seqirus 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

In this study, the safety and immunogenicity of the current formulation of aTIV will be compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in independently-living elderly subjects ≥ 65 years of… 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?
Adjuvanted, trivalent subunit influenza vaccine, Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine and Antigen level modified adjuvanted, trivalent subunit influenza vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteGermany
Study dates
Jun 2014to Nov 2015
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Male and female subjects ≥65 years of age on the day of screening who are healthy or have chronic illnesses that are stable and well controlled.
  • Subjects assessed as mentally competent, who have given informed consent after the nature of the study has been explained according to local requirements
  • In good health as determined by:
  • Ability to live independently
  • Medical history
  • Physical examination
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  • Clinical judgment of the Investigator
  • Able to understand and comply with all study procedures and visits, and are able to complete an eDiary
  • Individuals who have access to a working telephone and are able to receive periodic telephone calls

Who cannot join

  • Individuals who have received any type of influenza vaccine (licensed or experimental) within the past 6 months
  • Individuals who have received any other licensed vaccines within 30 days (for inactivated vaccines) or 42 days (for live vaccines) prior to enrollment in this study
  • Individuals who have cancer except for:
  • Benign localized skin cancer
  • Localized prostate cancer that has been clinically stable for ≥ 2 years without treatment
  • Cancer in remission for ≥ 10 years (from end of cancer treatment)
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  • Individuals with autoimmune disease (including rheumatoid arthritis)
  • Individuals with diabetes mellitus, type I
  • Individuals with a body mass index (BMI) ≤18 or ≥35.
  • Asthma that is greater than mild in severity and / or has exacerbations more than 2 days per week
  • Congestive heart failure with symptoms as severe as or more severe than dyspnea with short walks or climbing a single flight of stairs (for example, greater than New York Heart Association class 2)
  • History of progressive or severe neurologic disorders including but not limited to multiple sclerosis, Parkinson's disease, Guillain-Barré syndrome, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, epilepsy disorders requiring medication for control, encephalitis, Alzheimer's and CVA
  • Individuals who are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulfate or any other component of the vaccines in study
  • Individuals who have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
  • Individuals who have a known or suspected (or have a high risk of developing) impairment/alteration of immune function resulting from, for example,
  • Receipt of immunosuppressive therapy (defined as follows) within the past 60 days and/or anticipated to receive immunosuppressive therapy at any point within 21 days of Visit 1.
  • Cancer chemotherapy/radiotherapy ii. Systemic corticosteroids ( i.e., 15 mg or greater per day of prednisone or equivalent) iii. Chronic use of inhaled/intranasal high potency corticosteroids (budesonide 800 μg per day or fluticasone 750 μg per day) b. Receipt of immunostimulants c. Receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivate within the past 3 months and for the full length of the study d. Suspected or known HIV infection or HIV-related disease
  • Individuals who have a known or suspected history of drug or alcohol abuse
  • Individuals who, within the past 12 months, have had laboratory confirmed influenza disease
  • Individuals who, within the past 30 days have received any investigational agent.
  • Individuals who plan to receive another vaccine within 30 days of receipt of the study vaccination.
  • Individuals who, within the past 14 days, have experienced:
  • Any acute disease including any worsening of underlying respiratory diseases such as asthma or COPD
  • Infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
  • Individuals who are taking part in another clinical study
  • Individuals who are research staff directly involved with the clinical study or family members or household members of research staff. Research staff includes an individual with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.
  • Individuals with behavioral or cognitive impairment or a psychiatric condition that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
  • Vulnerable subjects, e.g. subjects kept in detention, soldiers, employees of the sponsor or a clinical research organization involved in this study
  • Individuals who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • PAREXEL Early Phase Clinical Unit

    Berlin, 14050

Other trials in Germany

About this study

Official title: A Phase 1, Randomized, Observer Blind, Antigen and Adjuvant Dosage-Finding Study to Evaluate the Safety and Immunogenicity of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects ≥65 Years of Age

In this study, the safety and immunogenicity of the current formulation of aTIV will be compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in independently-living elderly subjects ≥ 65 years of age.

Conditions
Influenza
Being tested
Adjuvanted, trivalent subunit influenza vaccine, Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine, Antigen level modified adjuvanted, trivalent subunit influenza vaccine, Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine
Keywords
Influenza, elderly, adjuvant
Medical subject headings
Influenza, Human

What participants receive

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

  • Adjuvanted, trivalent subunit influenza vaccineBiological

    Group 1 and group 5 are active comparators; group 5 includes placebo comparator as a second injection in contralateral deltoid

  • Adjuvant level modified adjuvanted, trivalent subunit influenza vaccineBiological

    Group 2 and group 6 are experimental; group 2 has double dosage of MF59 in a single injection; group 6 has triple dosage of MF59 and includes placebo comparator in contralateral deltoid

  • Antigen level modified adjuvanted, trivalent subunit influenza vaccineBiological

    Group 3 is experimental with double the usual antigen dosage

  • Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccineBiological

    Group 4 and 7 are experimental; group 4 has one injection with double the antigen and adjuvant; group 7 has two injections with double the antigen and adjuvant

Study groups in NCT02126761
Study groupRoleWhat they receive
Group 1Active comparatoraTIV
Receives: Biological: Adjuvanted, trivalent subunit influenza vaccine
Group 2ExperimentalaTIV + 1X MF59
Receives: Biological: Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine
Group 3ExperimentalaTIV + TIV
Receives: Biological: Antigen level modified adjuvanted, trivalent subunit influenza vaccine
Group 4ExperimentalaTIV + aTIV
Receives: Biological: Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine
Group 5Active comparatoraTIV (Left deltoid) Saline (Right deltoid)
Receives: Biological: Adjuvanted, trivalent subunit influenza vaccine
Group 6ExperimentalaTIV+2X MF59 (Left deltoid) Saline (Right deltoid)
Receives: Biological: Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine
Group 7ExperimentalaTIV (Left deltoid) aTIV (Right deltoid)
Receives: Biological: Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine

What is being measured

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

  1. Reactogenicity up to 7 days after vaccination

    Safety of aTIV or aTIV-modified formulations

    Measured: Days 1-7 post-vaccination

  2. Unsolicited AEs within 28 days after vaccination

    Measured: Days 1-28 post-vaccination

  3. SAEs, non-scheduled physician visits, unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, NOCDs, and AESIs from study start to study completion.

    Measured: Days 1-366 post-vaccination

  4. Seroconversion/significant increase in antibody HI titers; ≥4-fold rise in MN titer 21 days post-vaccination.

    Antibody responses to all three influenza virus vaccine strains, 21days after a dose or doses of aTIV or aTIV-modified formulations, as measured by hemagglutination inhibition (HI) assay and microneutralization (MN) assay.

    Measured: Day 22 post-vaccination

  5. HI and MN GMT and GMR at baseline and 21 days post-vaccination.

    Measured: Day 1; Day 22 post-vaccination

Secondary outcomes (4)

  1. Seroconversion/significant increase in antibody HI titers; ≥4-fold rise in MN titer, 7 days and 6 months post-vaccination.

    Measured: Day 8 and 181 post-vaccination

  2. HI and MN (GMT) 7 days and 6 months post-vaccination.

    To compare HI and MN responses to a aTIV or aTIV-modified formulations, at 7 days and 6 months post-vaccination.

    Measured: Day 8 and 181 post-vaccination

  3. HI and MN (GMR) 7 days, 21 days, and 6 months post-vaccination.

    Measured: Day 1, 8, 22, and 181 post-vaccination

  4. Percentage of subjects with HI titers ≥1:40, ≥1:110, ≥1:160, and ≥1:330 7 days, 21 days, and 6 months post-vaccination.

    To compare antibody responses in subjects receiving aTIV-modified formulations in a single intramuscular injection (in one deltoid) to two intramuscular injections (one in each deltoid) at 7 days, 21 days, and 6 months post-vaccination.

    Measured: Day 8, 22, and 181 post-vaccination

Timeline

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

  1. First posted30 Apr 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02126761
Sponsor's protocol ID
V133_01EXP
Other IDs
2013-005344-29
Status last verified
Dec 2015
First submitted
28 Apr 2014
Last updated
29 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Adjuvanted, trivalent subunit influenza vaccine, Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine and Antigen level modified adjuvanted, trivalent subunit influenza vaccine in people with Influenza, run by Seqirus 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 9 inclusion and 29 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 29 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Reactogenicity up to 7 days after vaccination (time frame: Days 1-7 post-vaccination). The study lists 5 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 NCT02126761.

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 29 Jul 2016.

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