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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01897701




Registration number
NCT01897701
Ethics application status
Date submitted
9/07/2013
Date registered
12/07/2013
Date last updated
13/10/2014

Titles & IDs
Public title
A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1
Scientific title
A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Anhui/1/2013 (H7N9) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Adults With and Without Adjuvant 1
Secondary ID [1] 0 0
NVX900.PH7.101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Group A - High dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 \& 21

Experimental: Group B - Intermediate dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 \& 21

Experimental: Group C - Intermediate dose Monovalent Avian Influenza VLP (H7N9) and Low dose Adjuvant 1; IM; Day 0 \& 21

Experimental: Group D - Low dose Monovalent Avian Influenza VLP (H7N9) and Low dose Adjuvant 1; IM; Day 0 \& Day 21

Experimental: Group E - Intermediate dose Monovalent Avian Influenza VLP (H7N9) and High dose Adjuvant 1; IM; Day 0 \& 21

Experimental: Group F - Low dose Monovalent Avian Influenza VLP (H7N9) and High dose Adjuvant 1; IM; Day 0 \& 21

Experimental: Group G - Placebo; IM; Day 0 \& 21
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of Safety
Timepoint [1] 0 0
Day 0 to Day 384
Primary outcome [2] 0 0
Immunogenicity as assessed by hemagglutination-inhibiting (HAI) antibody titers against the vaccine-homologous A/Anhui/1/13 (H7N9) virus.
Timepoint [2] 0 0
Day 0 to Day 384
Secondary outcome [1] 0 0
Immunogenicity as assessed by neuraminidase-inhibiting antibodies to N9.
Timepoint [1] 0 0
Day 0 to Day 384

Eligibility
Key inclusion criteria
Subjects must meet all of the following to be eligible for participation in the study:

1. Healthy adult male or female, =18 years of age,
2. Willing and able to give informed consent prior to study enrollment,
3. Able to comply with study requirements, and
4. Women of childbearing potential must have a negative urine pregnancy test prior to each 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 continuous abstinence from heterosexual activity or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), barrier contraceptives (condom or diaphragm), and intrauterine device (IUD). Women with an adequately documented history of surgical sterility, or =50 years of age and without menses for = 1 year are exempt from urine pregnancy testing.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects meeting any of the following criteria are not eligible for participation in the study.

1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.

* Asymptomatic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this study) in the opinion of the investigator.
* Note that illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (see exclusion criteria 2, 5, 7, 8).
2. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
3. History of a serious reaction to prior influenza vaccination.
4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
5. Received any vaccine in the 4 weeks preceding the study vaccination; or any A(H7N9) avian influenza vaccine at any time.
6. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
7. 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.
8. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
9. 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).
10. Known disturbance of coagulation.
11. Women who are pregnant or 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).
14. Persons employed in a capacity that involves handling poultry or wild birds.

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 1
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
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
280
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Q-Pharm Pty Limited - Herston
Recruitment hospital [2] 0 0
CMAX - Adelaide
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novavax
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, observer-blinded, placebo-controlled trial in adults =18 years old. Randomization will be stratified by age (18 to 49 years and =50 years) and by prior influenza immunization within the past three months. Proportions of subjects in the various strata will not be pre-specified; rather, the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the various treatment groups.

Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.
Trial website
https://clinicaltrials.gov/study/NCT01897701
Trial related presentations / publications
Fries LF, Smith GE, Glenn GM. A recombinant viruslike particle influenza A (H7N9) vaccine. N Engl J Med. 2013 Dec 26;369(26):2564-6. doi: 10.1056/NEJMc1313186. Epub 2013 Nov 13. No abstract available.
Public notes

Contacts
Principal investigator
Name 0 0
D. Nigel Thomas, Ph.D.
Address 0 0
Novavax, Inc.
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/study/NCT01897701