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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/NCT03026348
Registration number
NCT03026348
Ethics application status
Date submitted
17/01/2017
Date registered
20/01/2017
Date last updated
6/12/2021
Titles & IDs
Public title
Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults
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Scientific title
Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults
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Secondary ID [1]
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RSV-E-205
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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:
Respiratory Syncytial Viruses
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - RSV F Vaccine with Aluminum Phosphate Adjuvant
Other interventions - RSV F Vaccine
Other interventions - Matrix-M1 Adjuvant
Other interventions - Phosphate Buffer
Active Comparator: Treatment Group A - Day 0 RSV F Vaccine 135µg/0.5mL Day 21 Phosphate Buffer
Active Comparator: Treatment Group B - Day 0 Treatment / Formulation 1 Day 21 Phosphate Buffer
Active Comparator: Treatment Group C - Day 0 Treatment / Formulation 1 Day 21 Treatment / Formulation 1
Active Comparator: Treatment Group D - Day 0 Treatment / Formulation 2 Day 21 Phosphate Buffer
Active Comparator: Treatment Group E - Day 0 Treatment / Formulation 2 Day 21 Treatment / Formulation 2
Active Comparator: Treatment Group F - Day 0 Treatment / Formulation 3 Day 21 Phosphate Buffer
Active Comparator: Treatment Group G - Day 0 Treatment / Formulation 3 Day 21 Treatment / Formulation 3
Active Comparator: Treatment Group H - Day 0 Treatment / Formulation 4 Day 21 Phosphate Buffer
Active Comparator: Treatment Group J - Day 0 Treatment / Formulation 4 Day 21 Treatment / Formulation 4
Active Comparator: Treatment Group K - Day 0 Treatment / Formulation 5 Day 21 Phosphate Buffer
Active Comparator: Treatment Group L - Day 0 Treatment / Formulation 5 Day 21 Treatment / Formulation 5
Placebo Comparator: Treatment Group M - Day 0 Phosphate Buffer Day 21 Phosphate Buffer
Other interventions: RSV F Vaccine with Aluminum Phosphate Adjuvant
Other interventions: RSV F Vaccine
Other interventions: Matrix-M1 Adjuvant
Other interventions: Phosphate Buffer
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Intervention code [1]
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Other interventions
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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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Neutralizing antibody titers to at least one RSV/A strain
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Assessment method [1]
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Timepoint [1]
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Day 0, 21, 28
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Primary outcome [2]
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Subjects with solicited local and systemic AEs occurring within the 7-day period following dosings on Day 0 and Day 21 and all adverse events, solicited and unsolicited, occurring within the 56-day period of Day 0.
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Assessment method [2]
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Timepoint [2]
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Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56
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Secondary outcome [1]
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Serum concentrations of antibodies competitive with palivizumab (i.e., PCA) for binding to the RSV F protein.
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Assessment method [1]
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Timepoint [1]
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Day 0, 21, 28, 56, 119, 385
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Secondary outcome [2]
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Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
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Assessment method [2]
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Timepoint [2]
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Day 0, 21, 28, 56, 119, 385
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Secondary outcome [3]
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Counts of IFN-? spot forming units following in vitro stimulation of Day 0, Day 7, and Day 28 PBMC isolates with RSV F peptides.
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Assessment method [3]
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Timepoint [3]
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Day 0, 7, 28
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Secondary outcome [4]
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Counts and proportions of Day 0, Day 7, and Day 28 peripheral blood T cells positive by intracellular staining for IL-2, IFN-?, or TNF-a production (alone or any combination thereof) following in vitro stimulation with RSV F peptides.
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Assessment method [4]
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Timepoint [4]
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Day 0, 7, 28
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Eligibility
Key inclusion criteria
1. Males and females 60 through 80 years of age who are ambulatory and live in the
community or in an assisted-living facility that provides minimal assistance, such
that the subject is primarily responsible for self-care and activities of daily
living. Subjects may have one or more chronic medical diagnoses, but should be
clinically stable as assessed by:
- Absence of changes in medical therapy within one month due to treatment failure
or toxicity (dose adjustments of ongoing therapies for optimal effect, or
replacements within a class of drugs due to convenience or cost, will be deemed
acceptable),
- Absence of medical events qualifying as SAEs within one month of the planned
vaccination on Day 0, and
- Absence of known, current, and life-limiting diagnoses which, in the opinion of
the investigator, render survival to completion of the protocol unlikely.
2. Willing and able (on both a physical and cognitive basis) to give informed consent
prior to study enrollment. To complete the consent process, all qualifying subjects
will correctly answer at least 4 out of 5 questions of the informed consent form (ICF)
comprehension assessment in no more than 2 attempts.
3. Able to comply with study requirements. As the protocol procedures involve telephone
contacts for safety ascertainment, eligible subjects must have a reliable access to a
telephone.
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Minimum age
60
Years
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Maximum age
80
Years
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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
1. Received any prior RSV vaccine.
2. Participation in research involving any additional investigational product (drug /
biologic / device) within 45 days before planned date of first vaccination.
3. History of a serious reaction to any prior vaccination or a history of Guillain-Barré
syndrome (GBS) within 6 weeks of any prior influenza immunization.
4. Receipt of inactivated influenza vaccine within 14 days prior to the Day 0 dose of
test article or any other vaccine within the 4 weeks prior to the Day 0 dose of test
article.
5. Any known or suspected immunosuppressive condition, acquired or congenital, as
determined by 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. Known disturbance of coagulation. Potential subjects receiving aspirin, clopidogrel,
prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban, or warfarin under good
control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or
stroke in the setting of atrial fibrillation will NOT be excluded.
10. Suspicion or recent history (within one year of planned vaccination) of alcohol or
other substance abuse.
11. 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, cognitive, or psychiatric
conditions deemed likely to impair the quality of study compliance or safety
reporting).
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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
Completed
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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
1/01/2017
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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
18/05/2018
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Sample size
Target
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Accrual to date
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Final
300
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Research Site AU004 - Sydney
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Recruitment hospital [2]
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Research Site AU005 - Herston
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Recruitment hospital [3]
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Research Site AU002 - Adelaide
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Recruitment hospital [4]
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Research Site AU006 - Prahran
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Recruitment hospital [5]
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Resarch Site AU001 - Nedlands
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment postcode(s) [2]
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4006 - Herston
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Recruitment postcode(s) [3]
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50000 - Adelaide
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Recruitment postcode(s) [4]
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3181 - Prahran
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novavax
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300
eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into
multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will
be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions
of subjects in various strata will not be pre-specified and the goal will be to achieve an
approximately equal distribution of subjects with these characteristics across the treatment
groups. Serology measures consistent with the study outcomes will be reported.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03026348
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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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Clinical Development
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Address
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Novavax
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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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Country
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Phone
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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/NCT03026348
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