AzTrials
AzTrials

InfluenzaPhase 2NCT01561768

A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young Adults

A Phase 2 study testing Novavax Quadrivalent vaccine, Novavax Trivalent vaccine and cTIV in people with Influenza, run by Novavax at 4 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the immune response of three dose levels of the Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into 5 treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. 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?
Novavax Quadrivalent vaccine, Novavax Trivalent vaccine and cTIV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
4 sitesAustralia
Study dates
Mar 2012to Jan 2013
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

  • Healthy adult male or females, 18-64 years of age
  • Willing and able to give informed consent prior to study enrollment
  • Able to comply with study requirements
  • Women who are not post-menopausal (≥ 50 years of age and at least one year post last menses) or surgically sterile must have a negative urine pregnancy test at vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of abstinence from heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and intrauterine device (IUD)

Who cannot join

  • Participation in research involving investigational product (drug/biologic/device) within 45 days before planned date of first vaccination
  • History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed TIV (e.g., egg proteins) or polysorbate-80
  • History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine
  • Received any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within six months preceding the study vaccination
  • Any know or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination
  • Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
Show all 13Show fewer
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study
  • Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration)
  • Presence of chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a "high-risk" category for influenza and/or its complications
  • Known disturbance of coagulation
  • Women who are breastfeeding or plan to become pregnant during the study
  • Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse
  • Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting)

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • CMAX

    Adelaide

  • Emeritus Research

    Melbourne

  • Linear Clinical Research

    Perth

  • Holdsworth House

    Sydney

Other trials in Australia

About this study

Official title: A Phase 2 Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Quadrivalent Seasonal Virus-Like Particle (VLP) Influenza Vaccine (Recombinant) in Healthy Young (18-64) Adults

The purpose of this study is to determine the immune response of three dose levels of the Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into 5 treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. Group 1-3 will receive one of three dose levels of the Novavax Quadrivalent vaccine, Group 4 will receive a dose of the Novavax Trivalent vaccine, and Group 5 will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Novavax Quadrivalent vaccine.

Conditions
Influenza
Being tested
Novavax Quadrivalent vaccine, Novavax Trivalent vaccine, cTIV
Medical subject headings
Influenza, Human

What participants receive

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

  • Novavax Quadrivalent vaccineBiological

    Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid

  • Novavax Quadrivalent vaccineBiological

    Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid

  • Novavax Quadrivalent vaccineBiological

    Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid

  • Novavax Trivalent vaccineBiological

    Trivalent Dose; intramuscular injection, deltoid

  • cTIVBiological

    Preconfigured dose; intramuscular injection, deltoid

Study groups in NCT01561768
Study groupRoleWhat they receive
Group 1ExperimentalNot described
Receives: Biological: Novavax Quadrivalent vaccine
Group 2ExperimentalNot described
Receives: Biological: Novavax Quadrivalent vaccine
Group 3ExperimentalNot described
Receives: Biological: Novavax Quadrivalent vaccine
Group 4ExperimentalNot described
Receives: Biological: Novavax Trivalent vaccine
Group 5ExperimentalNot described
Receives: Biological: cTIV

What is being measured

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

  1. Immunogenicity of 3 dose levels of the Novavax Quadrivalent vaccine based on HAI responses

    Measured: Day 21

  2. Number of Solicited and Unsolicited Adverse Events for the Novavax Quadrivalent vaccine

    Measured: 6 months

Secondary outcomes (2)

  1. Estimate capacity of the Novavax Quadrivalent vaccines to fulfill FDA criteria (immunogenicity) for all strains in healthy, young adults

    Based on criteria of greater than or equal to 40% HAI seroconversion and greater than or equal to 70% of subjects with HAI titers greater than or equal to 1:40 post-vaccination.

    Measured: Day 21

  2. Impact of including a fourth strain in the Novavax Quadrivalent vaccine on immune responses to other three strains

    Based on comparison to a trivalent NovaFlu formulation tested at the 22.5ug of HA (per strain) dose level.

    Measured: Day 21

Timeline

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

  1. First posted23 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionJan 2013
  4. Study completionJan 2013

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01561768
Sponsor's protocol ID
NVX 778.S205
Status last verified
Jul 2013
First submitted
2 Mar 2012
Last updated
18 Jul 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Novavax Quadrivalent vaccine, Novavax Trivalent vaccine and cTIV in people with Influenza, run by Novavax at 4 sites in Australia.

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 4 inclusion and 13 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 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. 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?

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?

Immunogenicity of 3 dose levels of the Novavax Quadrivalent vaccine based on HAI responses (time frame: Day 21). The study lists 2 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 NCT01561768.

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 18 Jul 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in