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InfluenzaPhase 2NCT02434276

Study of the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (VAX2012Q) in Adults 18-64 Years

A Phase 2 study testing VAX2012Q and Fluzone Quadrivalent in people with Influenza, run by VaxInnate Corporation at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either one of two dose levels of VAX2012Q or a licensed quadrivalent influenza vaccine. The subjects will be randomized at a 1:1:1 ratio. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
VAX2012Q and Fluzone Quadrivalent
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
6 sitesUnited States
Study dates
May 2015to Jun 2016
Phase
Phase 2
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 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males and females, 18-64 years of age.
  • Females must be:
  • Surgically sterilized
  • Post menopausal:
  • 12 months of spontaneous amenorrhea or
  • 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 milli-International Units (mIU)/ml or
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  • 6 weeks postsurgical bilateral oophorectomy
  • 3. Those of childbearing potential must have a negative pre-treatment serum pregnancy test followed by a confirmatory urine pregnancy test immediately prior to vaccination and must agree to use a reliable form of contraception for at least 21 days post vaccination including contraceptives, intrauterine device, double-barrier method.
  • In good health as determined by medical history, physical exam, laboratory assessments and the clinical judgment of the Principal Investigator.
  • Must sign informed consent indicating understanding of the purpose of and procedures required for the study and willingness to participate.

Who cannot join

  • Within 6 months preceding the administration of the study vaccine, receiving any licensed or investigational vaccine.
  • Within 30 days preceding the administration of the study vaccine, receiving any investigational drug.
  • Excessive chronic alcohol use within the last 5 years.
  • History of drug abuse, other than recreational cannabis use, within the last 5 years that could affect the subject's participation in the study.
  • Significant psychiatric illness within the last 12 months which would interfere with the study.
  • A chronic illness that is not medically stable, receiving a concomitant therapy in which the medication dose has not been stable for at least 3 months prior to immunization or has any other condition that could interfere with the study.
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  • Clinically significant abnormal liver function tests at screening: alanine transaminase (ALT) or aspartate aminotransferase (AST) >2.5 Upper Limit of Normal (ULN).
  • Total bilirubin > 1.5 ULN if ALT or AST > ULN or total bilirubin > 2 ULN with ALT and AST within normal range .
  • Creatinine >1.7mg/dL, Hemoglobin < 11g/dL for females; <12.5 g/dL for males, white blood cells (WBC) <2500cell/mm3 or > 15,000cell/mm3, Platelet Count <125,000cell/mm3
  • Positive serology for HBSAg, hepatitis C virus (HCV) or HIV
  • Have cancer or have received treatment for cancer within three years, excluding in situ cervical carcinoma or basal /squamous cell carcinoma of the skin at other than the vaccination site.
  • Any autoimmune disease.
  • Presently receiving or having a recent history of receiving (≤ six months) any medication or therapeutic modality that affects the immune system or a drug known to be frequently associated with significant major organ toxicity or system corticosteroids (oral or injectable).
  • History of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza vaccine component.
  • Allergic to egg or egg products.
  • History of Guillain-Barré Syndrome.
  • Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the three week study period following vaccination
  • Donation of blood or blood products within 4 weeks prior to vaccination or during the 4 week study period following vaccination.
  • Acute disease within 72 hours prior to vaccination.
  • An oral temperature >100.4°F (38°C) on the day of vaccination
  • Body Mass Index >40.
  • Known bleeding disorders or receiving prescribed oral or parenteral anticoagulants.
  • Any other condition or circumstance which, in the opinion of the Principal Investigator, poses an unacceptable risk for participation in the study or could interfere with study evaluations.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Optimal Research

    Huntsville, Alabama, 35802

  • Optimal Research

    Melbourne, Florida, 32934

  • Optimal Research

    Mishawaka, Indiana, 46545

  • Optimal Research

    Peoria, Illinois, 61614

  • Optimal Research

    Rockville, Maryland, 20850

  • Optimal Research

    San Diego, California, 92108

Other trials in United States

About this study

Official title: A Phase II, Multicenter, Randomized, Double-Blind, Active Comparator Controlled Study of the Immunogenicity and Safety of VAX2012Q, A Quadrivalent Influenza Vaccine in Healthy Adults 18-64 Years

This is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either one of two dose levels of VAX2012Q or a licensed quadrivalent influenza vaccine. The subjects will be randomized at a 1:1:1 ratio.

Read the detailed description

This is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either VAX2012Q or Fluzone. Four hundred fifty (450) subjects will be randomized 1:1:1 ratio of either 8 or 12 mcg VAX2012Q dose levels or to Fluzone® Quadrivalent vaccine.

Randomization will be stratified for age (18-49 and 50-64 years). Subjects will be stratified by two age groups (18-49 and 50-64) and randomized in a 1:1:1 ratio to either 8 or 12 mcg VAX2012Q dose levels or to Fluzone® Quadrivalent vaccine. 25-35% of the total study population will be recruited into the 50-64 age group.

The primary objective of the study is to evaluate the seroconversion rates at Day 21 for both dose levels of VAX2012Q.

Conditions
Influenza
Being tested
VAX2012Q, Fluzone Quadrivalent
Medical subject headings
Influenza, Human

What participants receive

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

  • VAX2012QBiological

    Also called Quadrivalent Recombinant Hemagglutinin Influenza Vaccine, RIV4

    Recombinant influenza hemagglutinin (HA) vaccine consisting of two influenza A subtypes and two influenza B lineages

  • Fluzone QuadrivalentBiological

    Also called IIV4

    Fluzone Quadrivalent (Influenza Vaccine)

Study groups in NCT02434276
Study groupRoleWhat they receive
Vaccine Dose Group 8 mcg doseExperimentalVAX2012Q, 8 mcg dose
Receives: Biological: VAX2012Q
Vaccine Dose Group 12 mcg doseExperimentalVAX2012Q, 12 mcg dose
Receives: Biological: VAX2012Q
ControlActive comparatorFluzone Quadrivalent vaccine
Receives: Biological: Fluzone Quadrivalent

What is being measured

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

  1. Seroconversion rates to the 4 components of VAX2012Q

    Immune response to the vaccine will be measured in sera by the hemagglutination inhibition (HAI) assay.

    Measured: Through day 21

Secondary outcomes (4)

  1. Safety following vaccination assessed by Adverse events (AEs)

    vital signs, laboratory test results and analgesic and antipyretic use to treat symptoms emerging post vaccination will be collected.

    Measured: Through day 21

  2. Immunogenicity of the two dose levels of VAX2012Q and of Fluzone Quadrivalent

    Immune responses to the vaccines will be measured in sera by HAI assay.

    Measured: Through day 21

  3. C-reactive protein levels

    Measure C-reactive protein levels.

    Measured: Through day 7

  4. Long term safety following vaccination assessed by Clinically significant AEs

    including Serious Adverse Events, Adverse Events of Special Interest and new onset chronic diseases, will be collected.

    Measured: After Day 21 through one year

Timeline

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

  1. First posted5 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionAug 2015 (estimated)
  4. Study completionJun 2016 (estimated)

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02434276
Sponsor's protocol ID
VAX2012Q-03
Status last verified
Jun 2015
First submitted
16 Apr 2015
Last updated
26 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VAX2012Q and Fluzone Quadrivalent in people with Influenza, run by VaxInnate Corporation at 6 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 10 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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?

Seroconversion rates to the 4 components of VAX2012Q (time frame: Through day 21). 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 NCT02434276.

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 26 Jun 2015.

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