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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01561768




Registration number
NCT01561768
Ethics application status
Date submitted
2/03/2012
Date registered
23/03/2012
Date last updated
18/07/2013

Titles & IDs
Public title
A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young Adults
Scientific 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
Secondary ID [1] 0 0
NVX 778.S205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Novavax Quadrivalent vaccine
Other interventions - Novavax Quadrivalent vaccine
Other interventions - Novavax Quadrivalent vaccine
Other interventions - Novavax Trivalent vaccine
Other interventions - cTIV

Experimental: Group 1 -

Experimental: Group 2 -

Experimental: Group 3 -

Experimental: Group 4 -

Experimental: Group 5 -


Other interventions: Novavax Quadrivalent vaccine
Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid

Other interventions: Novavax Quadrivalent vaccine
Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid

Other interventions: Novavax Quadrivalent vaccine
Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid

Other interventions: Novavax Trivalent vaccine
Trivalent Dose; intramuscular injection, deltoid

Other interventions: cTIV
Preconfigured dose; intramuscular injection, deltoid
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Immunogenicity of 3 dose levels of the Novavax Quadrivalent vaccine based on HAI responses
Timepoint [1] 0 0
Day 21
Primary outcome [2] 0 0
Number of Solicited and Unsolicited Adverse Events for the Novavax Quadrivalent vaccine
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Estimate capacity of the Novavax Quadrivalent vaccines to fulfill FDA criteria (immunogenicity) for all strains in healthy, young adults
Timepoint [1] 0 0
Day 21
Secondary outcome [2] 0 0
Impact of including a fourth strain in the Novavax Quadrivalent vaccine on immune responses to other three strains
Timepoint [2] 0 0
Day 21

Eligibility
Key inclusion criteria
1. Healthy adult male or females, 18-64 years of age

2. Willing and able to give informed consent prior to study enrollment

3. Able to comply with study requirements

4. 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)
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participation in research involving investigational product (drug/biologic/device)
within 45 days before planned date of first vaccination

2. History of a serious reaction to prior influenza vaccination, known allergy to
constituents of licensed TIV (e.g., egg proteins) or polysorbate-80

3. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza
vaccine

4. Received any vaccine in the 4 weeks preceding the study vaccination and any influenza
vaccine within six months preceding the study vaccination

5. Any know or suspected immunosuppressive illness, congenital or acquired, based on
medical history and/or physical examination

6. 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.

7. Administration of immunoglobulins and/or any blood products within the 3 months
preceding the administration of the study vaccine or during the study

8. 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)

9. 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

10. Known disturbance of coagulation

11. Women who are breastfeeding or plan to become pregnant during the study

12. Suspicion or recent history (within one year of planned vaccination) of alcohol or
other substance abuse

13. 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
500
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment hospital [2] 0 0
Emeritus Research - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research - Perth
Recruitment hospital [4] 0 0
Holdsworth House - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novavax
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Department of Health and Human Services
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01561768
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nigel Thomas, Ph.D.
Address 0 0
Novavax
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01561768