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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561768
• Other study ID #: NVX 778.S205
• Status: Completed
• Phase: Phase 2
• First received: March 2, 2012
• Last updated: July 16, 2013
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: July 2013
• Source: Novavax
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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)

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Novavax Quadrivalent vaccine
Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid
• Novavax Quadrivalent vaccine
Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid
• Novavax Quadrivalent vaccine
Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid
• Novavax Trivalent vaccine
Trivalent Dose; intramuscular injection, deltoid
• cTIV
Preconfigured dose; intramuscular injection, deltoid

Locations

Country	Name	City	State
Australia	CMAX	Adelaide
Australia	Emeritus Research	Melbourne
Australia	Linear Clinical Research	Perth
Australia	Holdsworth House	Sydney

Sponsors (2)

Lead Sponsor	Collaborator
Novavax	Department of Health and Human Services

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity of 3 dose levels of the Novavax Quadrivalent vaccine based on HAI responses		Day 21	No
Primary	Number of Solicited and Unsolicited Adverse Events for the Novavax Quadrivalent vaccine		6 months	Yes
Secondary	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.	Day 21	No
Secondary	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.	Day 21	No

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