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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03880474




Registration number
NCT03880474
Ethics application status
Date submitted
21/02/2019
Date registered
19/03/2019

Titles & IDs
Public title
Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults
Scientific title
A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults Aged 18 Years and Over
Secondary ID [1] 0 0
FLU009
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 - MVA-NP+M1
Treatment: Drugs - Saline

Experimental: MVA-NP+M1 - Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.)

Placebo comparator: Saline Placebo - Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%)


Treatment: Other: MVA-NP+M1
Trial Vaccine

Treatment: Drugs: Saline
Sodium Chloride Placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR).
Timepoint [1] 0 0
210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019) in line with official Australian influenza season.
Secondary outcome [1] 0 0
Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary
Timepoint [1] 0 0
210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
Secondary outcome [2] 0 0
Number and Percentage of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms for 7 Days Following Vaccination (and Occurrence of Serious Adverse Events SAEs)
Timepoint [2] 0 0
7 days to a total of 210 days for SAEs (over the duration of the influenza season, between 01 May and 15 October)
Secondary outcome [3] 0 0
Number of Participants With Immunogenic Response (Immunogenicity of MVA-NP+M1 in Adjunction With Licensed QIV as Assessed Via Titres of Influenza-specific Neutralizing Antibodies)
Timepoint [3] 0 0
Day 28 and Week 26
Secondary outcome [4] 0 0
Duration of Influenza-like Illness (ILI) as Derived From Daily ILI eDiary
Timepoint [4] 0 0
210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
Secondary outcome [5] 0 0
Severity of Influenza-like Illness (ILI) Derived From Daily ILI eDiary as Time Weighted AUC
Timepoint [5] 0 0
210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
Secondary outcome [6] 0 0
Number of Participants With Immunogenic Response to MVA-NP+M1 (as Assessed Via the Frequency of Influenza-specific T-cells)
Timepoint [6] 0 0
Day 28 and Week 26

Eligibility
Key inclusion criteria
* Healthy male or female adults aged 18 years and over
* Receipt of a standard-dose licensed influenza QIV vaccine on the day of, or within 28 days prior to, randomisation
* A female participant is eligible for this study if she is not pregnant or breast feeding and one of the following:

1. Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year)
2. Of childbearing potential but agrees to practice effective contraception 8 weeks post-vaccination and has a negative urine pregnancy test pre-vaccination. Acceptable methods of contraception include one or more of the following:

i. Male partner who is sterile prior to the female participant's entry into the study and is the sole sexual partner for the female participant ii. Implants of levonorgestrel iii. Injectable progestogen iv. An intrauterine device with a documented failure rate of <1% v. Oral contraceptives vi. Double barrier methods including diaphragm or condom vii. Abstinence as long as it is line with the usual and preferred lifestyle of the participant
* Participant is willing and has capacity to provide written informed consent for participation in the study (in the Investigator's opinion)
* Able and willing (in the Investigator's opinion) to comply with all study requirements
* Willing to allow the Investigators to discuss the participant's medical history with their healthcare provider
* Present and able to visit the clinic in the event of an ILI episode during the influenza season
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigator, would either put the participant at risk because of participation in the study, or may influence the result of the study
* Receipt of any investigational product within 6 months prior to study, or prior participation in a clinical study of any Influenza vaccine and agreement not to participate in another clinical study for the duration of study follow-up
* Prior receipt of an investigational vaccine likely to impact on interpretation of the study data
* Active infection with HIV, Hepatitis B or Hepatitis C (from patient history or medical records)
* History of severe allergic reactions (e.g. anaphylaxis)
* History of auto-immune disease e.g. Guillain-Barré syndrome
* Not willing to comply with study procedures
* Immunosuppressed or taking immunosuppressive medications
* Use of warfarin or other blood thinning medications (aspirin is acceptable)
* Tattoos or birthmarks at the vaccination site
* Participant bruises easily, has haematoma or keloid scarring
* Receipt of a licenced inactivated vaccine (e.g. pneumococcal vaccine) within 2 weeks prior to vaccination
* Receipt of an off licensed live vaccine (e.g. herpes zoster vaccine) within 4 weeks prior to vaccination

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 administering 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/01/2020
Sample size
Target
Accrual to date
Final
2364
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Pty Ltd - Blacktown
Recruitment hospital [2] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [3] 0 0
Paratus Clinical Pty Ltd - Kanwal
Recruitment hospital [4] 0 0
Scientia Clinical Research - Sydney
Recruitment hospital [5] 0 0
University of Sunshine Coast (USC) - Morayfield
Recruitment hospital [6] 0 0
University of Sunshine Coast (USC) - Sippy Downs
Recruitment hospital [7] 0 0
Mater Research - South Brisbane
Recruitment hospital [8] 0 0
CMAX - Adelaide
Recruitment hospital [9] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2031 - Sydney
Recruitment postcode(s) [5] 0 0
4506 - Morayfield
Recruitment postcode(s) [6] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Barinthus Biotherapeutics
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Clinical Network Services (CNS) Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
James Vandeleur, MD
Address 0 0
Paratus Clinical Pty Ltd
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03880474