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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02247362




Registration number
NCT02247362
Ethics application status
Date submitted
18/09/2014
Date registered
25/09/2014
Date last updated
17/04/2015

Titles & IDs
Public title
Study of Safety and Immunogenicity of a Quadrivalent Influenza Vaccine in Healthy Adults Age 65-75 Years
Scientific title
Phase 1b/2 Double Blind, Randomized, Placebo Controlled Study of Safety and Immunogenicity of VAX2012Q: A Quadrivalent Influenza Vaccine in Healthy Adults Age 65-75 Years
Secondary ID [1] 0 0
VAX2012Q-02
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
Treatment: Other - VAX2012Q
Other interventions - Placebo

Experimental: Vaccine Dose Group 12 mcg - VAX2012Q, 12 mcg dose

Experimental: Vaccine Dose Group 20 mcg - VAX2012Q, 20 mcg dose

Experimental: Vaccine Dose Group 16 mcg - VAX2012Q; 16 mcg dose

Placebo comparator: Vaccine Diluent - Vaccine Diluent, F147, as placebo control


Treatment: Other: VAX2012Q
Recombinant influenza HA vaccine consisting of two Influenza A subtypes and two Influenza B lineages and delivered IM

Other interventions: Placebo
Vaccine Diluent
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Injection site and systemic symptoms will be collected for 21 days after vaccination. Other AEs assessed as related to vaccination will be collected at a 6 month and 1 year phone call.
Timepoint [1] 0 0
21 days post-immunization; follow up at 6 months and one year
Secondary outcome [1] 0 0
Immune response to vaccine will be measured by serum HAI levels
Timepoint [1] 0 0
21 days post-immunization

Eligibility
Key inclusion criteria
* Males and females aged 65-75 years of age at the time of vaccination in good health. Individuals that are stably treated for hypertension may be eligible.
* Able to provide informed consent
* Willing to receive the unlicensed vaccine
* Willing to provide multiple blood specimens
* Live in the community, independently or in an assisted living environment
* Based on the results of the Short Portable Mental Status Questionnaire be rated as normal or have no greater than mild severity dementia
* As defined by the Canadian Study of Health and Aging Clinical Frailty Scale be a Class 1 to 5
Minimum age
65 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Preceding the administration of study vaccine, has received or will receive 1) any licensed or investigational influenza vaccine product within 6 months, 2) any investigational drug or any investigational vaccine product other than influenza vaccine within the 30 days, 3) any licensed live vaccine other than influenza vaccine within 4 weeks, 4) any licensed inactivated vaccine other than influenza vaccine within 2 weeks
* Planned receipt before the Day 21 blood draw of 1) any licensed or investigational influenza vaccine product, 2) any investigational drug or any investigational vaccine product other than influenza vaccine, 3) any licensed live vaccine other than influenza vaccine, 4) any licensed inactivated vaccine other than influenza vaccine
* History of excessive alcohol use, drug abuse or significant psychiatric illness
* Has a chronic illness that is not medically stable, is receiving a concomitant therapy in which the medication dose has not been stable for at least 3 weeks prior to immunization or has any other condition that could interfere with the subject's participation in the study or interpretation of the study results
* Clinically significant abnormal liver function tests at screening
* Subjects with Grade 2 or higher abnormalities in total bilirubin at screening
* Subjects with any of the following laboratory abnormalities at screening: Creatinine >1.7mg/dL, Hemoglobin < 11g/dL for females; <12.5 g/dL for males, WBC <2500cell/mm3 or > 15,000cell/mm3 and Platelet Count <125,000cell/mm3
* Positive serology of HBSAg, HCV or HIV antibodies
* Having cancer or have received treatment for cancer within three years, excluding minor skin cancers, which are allowed unless located at the vaccination site. Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
* Persons with impaired immune responsiveness (of any cause), including Type 1 diabetes mellitus and auto immune disorders or any known or suspected autoimmune disease
* Persons with congenital immunodeficiency or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months.
* Persons with a history of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza vaccine component
* Persons with a history of Guillain-Barré Syndrome
* Receipt or donation of blood or blood products 8 weeks prior to vaccination or during the three week study period following vaccination
* Acute disease within 72 hours prior to vaccination.
* An oral temperature >100.4°F (38°C)
* Systolic blood pressure < 85 mm Hg and subjects whose hypertension is untreated or unstable with antihypertensive therapy or that have systolic BP = 160 mm Hg or diastolic BP = 100 mm Hg requiring medical intervention with more than one drug or more intensive therapy than previously used or indicated.
* Body Mass Index >40
* Disorders of coagulation
* Women less than 1 year post menopausal
* A clinical diagnosis of influenza within the previous 6 months
* Any other condition or circumstance which, in the opinion of the Principal Investigator, poses an unacceptable risk for participation in the study

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2016
Actual
Sample size
Target
200
Accrual to date
Final
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, a division of IDT Australia Limited - Adelaide
Recruitment hospital [3] 0 0
Linear Clinical Research Limited - 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
VaxInnate Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lynda Tussey, PHD
Address 0 0
VaxInnate Corporation
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02247362