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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/NCT03880474
Registration number
NCT03880474
Ethics application status
Date submitted
21/02/2019
Date registered
19/03/2019
Date last updated
26/04/2021
Titles & IDs
Public title
Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults
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Scientific title
A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults Aged 18 Years and Over
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Secondary ID [1]
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FLU009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - 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%)
Other interventions: MVA-NP+M1
Trial Vaccine
Treatment: Drugs: Saline
Sodium Chloride Placebo
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR).
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Assessment method [1]
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The measure used reverse transcription polymerase chain reaction (RT-PCR) on deep nasal/mid-turbinate swab samples to record confirmed cases of influenza.
If influenza symptoms are experienced at any time during the Follow Up period, after the vaccination, participants will attend the clinic on two occasions, the first as soon as possible and at least within 72 hours of the onset of symptoms for deep nasal swabs to be taken. Both swabs must be taken within 96 hours of symptom onset.
The incidence rate of laboratory confirmed influenza using RT-PCR will be estimated for each vaccine group. The 95% CI for the incidence rate will be estimated by mid-p exact method. The difference in incidence rate between vaccine groups will be compared by Fisher's exact method.
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Timepoint [1]
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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.
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Secondary outcome [1]
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Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary
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Assessment method [1]
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ILI is defined as feeling feverish or having a fever (feeling feverish or having a fever (=37.8Celsius)) and at least one of the following symptoms: cough, sore throat.
The incidence rate of ILI by the participant completing of eDiaries will be estimated for each vaccine group. The 95% CI for the incidence will be estimated by mid-p exact method. The difference in incidence between groups will be compared by Fisher's exact method.
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Timepoint [1]
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210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
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Secondary outcome [2]
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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)
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Assessment method [2]
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The solicited adverse events are commonly observed soon after receipt of vaccines and relate to local and systemic signs and symptoms.
The solicited local injection site reactions (ISR) include pain, induration, warmth, and erythema (redness).
The solicited systemic reactions include feverishness, chills, myalgia, fatigue, headache, nausea, arthralgia, and malaise.
Participants completed eDiaries post vaccination to record ISR and systemic reactogenicity over the first 7 days post-vaccination (and the ongoing (S)AEs throughout the study).
The participant reporting of all ISR categories and solicited systemic reactions was compared between the MVA-NP+M1 treated group and the Placebo treated group.
Diary reported ISRs and solicited systemic reactions were summarized, by vaccination group, using descriptive statistics.
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Timepoint [2]
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7 days to a total of 210 days for SAEs (over the duration of the influenza season, between 01 May and 15 October)
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Secondary outcome [3]
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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)
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Assessment method [3]
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The numbers of Immunogenic Participants (participants with positive immune response as assessed at Day 28 and week 26 in relation to the baseline day 0 Immunogenicity) were summarized and listed.
The immunogenicity here was assessed as the geometric mean titers of influenza-specific neutralizing antibodies at different timepoints in relation to the baseline, against the antigens included in the licensed QIV(Influenza A/H3N2 (HI), Influenza A/H3N2 (MN), Influenza A/H3N2 (H1N1pdm), Influenza B/Victoria, and Influenza B/Yamagata).
The neutralizing antibody assays included microneutralisation and hemagglutination inhibition titers using standard methodologies for the four strains that were in the licensed vaccine.
The immunogenicity analyses were conducted only on the Immunology Analysis Set of Participants.
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Timepoint [3]
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Day 28 and Week 26
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Secondary outcome [4]
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Duration of Influenza-like Illness (ILI) as Derived From Daily ILI eDiary
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Assessment method [4]
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The duration of ILI is defined as the duration (days) from the first day ILI criteria met (as defined at the Secondary Outcome Measure 2) until the first day afterwards ILI criteria not met (event, ILI recovery).
ILI positive participants with ILI criteria met throughout the entire influenza season were censored at the last day recorded with the ILI dairy.
Survival analysis was used for the analysis of duration of ILI. The survival function for the duration of ILI was estimated by the Kaplan-Meier method.
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Timepoint [4]
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210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
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Secondary outcome [5]
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Severity of Influenza-like Illness (ILI) Derived From Daily ILI eDiary as Time Weighted AUC
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Assessment method [5]
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The severity of ILI was assessed by each participant completing of electronic Diaries for symptom severity daily for the following symptoms: Feeling hot, Temperature, Cough, Sore throat, Blocked nose, Chest pain, Muscle aches, Shortness of breath with their severities (scores) recorded as: Not Present (0), Mild (1), Moderate (2), Severe (3). For each symptom, the severity score was used to calculate the area under the curve (AUC), along with the calendar day, for the entire influenza season using trapezoidal rule. Participants could be followed for varying days in the influenza season, therefore the AUC will be time weighted to 168 days: Time weighted AUC=((raw AUC [time in days])/(number of days used for analysis)) * 168
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Timepoint [5]
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210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
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Secondary outcome [6]
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Number of Participants With Immunogenic Response to MVA-NP+M1 (as Assessed Via the Frequency of Influenza-specific T-cells)
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Assessment method [6]
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The numbers of immunogenic Participants (with positive immune response as assessed at Day 28 and week 26 in relation to the baseline day 0 Immunogenicity) were listed.
The immunogenicity here was determined via the frequency of influenza-specific T-cells measured by IFN-?/granzyme B ELISpot assay (enzyme linked immunospot) where the adjusted Spot Forming Units (SFU) per million PBMCs (peripheral blood mononuclear cells) after background subtraction (dimethyl sulfoxide, DMSO) were counted.
The immunogenicity analyses were conducted only in the Immunology Analysis Set of Participants.
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Timepoint [6]
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Day 28 and Week 26
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/01/2020
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Sample size
Target
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Accrual to date
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Final
2364
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Paratus Clinical Pty Ltd - Blacktown
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Recruitment hospital [2]
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Genesis Research Services - Broadmeadow
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Recruitment hospital [3]
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Paratus Clinical Pty Ltd - Kanwal
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Recruitment hospital [4]
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Scientia Clinical Research - Sydney
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Recruitment hospital [5]
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University of Sunshine Coast (USC) - Morayfield
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Recruitment hospital [6]
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University of Sunshine Coast (USC) - Sippy Downs
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Recruitment hospital [7]
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Mater Research - South Brisbane
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Recruitment hospital [8]
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CMAX - Adelaide
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Recruitment hospital [9]
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Nucleus Network Pty Ltd - Melbourne
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2292 - Broadmeadow
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Recruitment postcode(s) [3]
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2259 - Kanwal
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Recruitment postcode(s) [4]
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2031 - Sydney
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Recruitment postcode(s) [5]
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4506 - Morayfield
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Recruitment postcode(s) [6]
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4556 - Sippy Downs
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Recruitment postcode(s) [7]
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4101 - South Brisbane
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Recruitment postcode(s) [8]
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5000 - Adelaide
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Recruitment postcode(s) [9]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Barinthus Biotherapeutics
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Clinical Network Services (CNS) Pty Ltd
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults
aged 18 years and over. To assess the effect of MVA-NP+M1 on the reduction of laboratory
confirmed influenza when given as an adjunct to licensed quadrivalent influenza vaccine (QIV)
in adults
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03880474
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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James Vandeleur, MD
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Address
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Paratus Clinical Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03880474
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