Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04782323
Registration number
NCT04782323
Ethics application status
Date submitted
1/03/2021
Date registered
4/03/2021
Date last updated
10/10/2024
Titles & IDs
Public title
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults
Query!
Scientific title
A Phase 2, Randomized, Observer-blind, Antigen and Adjuvant Dose Ranging Clinical Study to Evaluate Safety and Immunogenicity of Different Formulations of MF59 Adjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine (aQIVc) in Older Adults =50 Years of Age
Query!
Secondary ID [1]
0
0
V201_01
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Influenza
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - aQII-1
Treatment: Drugs - aQII-3 Investigational
Treatment: Drugs - aQII-6 Investigational
Other interventions - aQII-7 Investigational
Treatment: Drugs - aQII-9 Investigational
Treatment: Drugs - aQII-10 Investigational
Treatment: Drugs - aQII-11 Investigational
Treatment: Drugs - Licensed QII Active Comparator
Experimental: Group A aQII-1 Investigational -
Experimental: Group B aQII-3 Investigational -
Experimental: Group C aQII-6 Investigational -
Experimental: Group D aQII-7 Investigational -
Experimental: Group E aQII-9 Investigational -
Experimental: Group F aQII-10 Investigational -
Experimental: Group G aQII-11 Investigational -
Active comparator: Group H Licensed QII Active Comparator -
Treatment: Drugs: aQII-1
Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Treatment: Drugs: aQII-3 Investigational
Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Treatment: Drugs: aQII-6 Investigational
Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Other interventions: aQII-7 Investigational
Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Treatment: Drugs: aQII-9 Investigational
Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Treatment: Drugs: aQII-10 Investigational
Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Treatment: Drugs: aQII-11 Investigational
Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Treatment: Drugs: Licensed QII Active Comparator
Biological/Vaccine: Licensed QII Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
[28 days post-vaccination]
Query!
Primary outcome [2]
0
0
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
28 days post-vaccination
Query!
Primary outcome [3]
0
0
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay
Query!
Assessment method [3]
0
0
Seroconversion is defined as =4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (=1:10), or a post-vaccination titer =1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
Query!
Timepoint [3]
0
0
28 days post-vaccination
Query!
Primary outcome [4]
0
0
Immunogenicity Endpoint: Percentage of Subjects With HI Titer =1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
28 days post-vaccination
Query!
Primary outcome [5]
0
0
Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions
Query!
Assessment method [5]
0
0
Percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination
Query!
Timepoint [5]
0
0
7 days post-vaccination
Query!
Primary outcome [6]
0
0
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
Query!
Assessment method [6]
0
0
The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29. Related AEs = considered at least possibly related to study vaccination by the investigator
Query!
Timepoint [6]
0
0
28 days post-vaccination
Query!
Primary outcome [7]
0
0
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
28 days post-vaccination
Query!
Secondary outcome [1]
0
0
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
180 days post-vaccination
Query!
Secondary outcome [2]
0
0
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
28 days post-vaccination
Query!
Secondary outcome [3]
0
0
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
28 days post-vaccination
Query!
Secondary outcome [4]
0
0
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay
Query!
Assessment method [4]
0
0
Seroconversion is defined as =4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (=1:10), or a post-vaccination titer =1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
Query!
Timepoint [4]
0
0
28 days post-vaccination
Query!
Secondary outcome [5]
0
0
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
180 days post-vaccination
Query!
Secondary outcome [6]
0
0
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
180 days post-vaccination
Query!
Secondary outcome [7]
0
0
Immunogenicity Endpoint: Percentage of Subjects With HI Titer =1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
180 days post-vaccination
Query!
Secondary outcome [8]
0
0
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
180 days post-vaccination
Query!
Secondary outcome [9]
0
0
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
180 days post-vaccination
Query!
Eligibility
Key inclusion criteria
INCLUSION CRITERIA:
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
1. Individuals =50 years of age on the day of informed consent.
2. Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who can comply with study procedures including follow-up .
4. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination.
EXCLUSION CRITERIA:
In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:
1. Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for at least 2 months after the study vaccination.
2. Progressive, unstable or uncontrolled clinical conditions.
3. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
4. History of any medical condition considered an adverse event of special interest (AESI).
5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
6. Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.
7. Abnormal function of the immune system resulting from:
1. Clinical conditions.
2. Systemic administration of corticosteroids (PO/IV/IM) at a dose of =20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent.
3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
9. Receipt of an investigational or non-registered medicinal product within 30 days prior to vaccination.
10. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
11. Study personnel or immediate family or household member of study personnel.
12. Receipt of any influenza vaccine within 6 months prior to vaccination in this study, or plan to receive an influenza vaccine during the study period.
13. Acute (severe) febrile illness.
14. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
13/04/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
3/03/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
839
Query!
Recruitment in Australia
Recruitment state(s)
CanberraNSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
03607 - PCRN_Paratus Clinical Research - Bruce
Query!
Recruitment hospital [2]
0
0
03605 - PCRN_Paratus Clinical Research (Central Coast) - Blacktown
Query!
Recruitment hospital [3]
0
0
3610- Emeritis Research - Botany
Query!
Recruitment hospital [4]
0
0
3609 - Northern Beaches Clinical Research [NSW] - Brookvale
Query!
Recruitment hospital [5]
0
0
03602 - PCRN_Paratus Clinical Research,(Western Sydney) [NSW] - Kanwal
Query!
Recruitment hospital [6]
0
0
03608 - Australian Clinical Research Network - ACRN [NSW] - Maroubra
Query!
Recruitment hospital [7]
0
0
03604 - University of the Sunshine Coast Clinical Trials Centre - Morayfield
Query!
Recruitment hospital [8]
0
0
03603 - University of the Sunshine Coast - Sippy Downs
Query!
Recruitment hospital [9]
0
0
03601 - AusTrials Taringa [QLD] - Taringa
Query!
Recruitment hospital [10]
0
0
03606 - AusTrials Tarragindi (Aus Trial Wellers Hill)[QLD] - Tarragindi
Query!
Recruitment hospital [11]
0
0
3611 - The University of Melbourne Peter Doherty Institute for Infection and Immunity - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2617 - Bruce
Query!
Recruitment postcode(s) [2]
0
0
2148 - Blacktown
Query!
Recruitment postcode(s) [3]
0
0
2019 - Botany
Query!
Recruitment postcode(s) [4]
0
0
2100 - Brookvale
Query!
Recruitment postcode(s) [5]
0
0
2259 - Kanwal
Query!
Recruitment postcode(s) [6]
0
0
2035 - Maroubra
Query!
Recruitment postcode(s) [7]
0
0
4506 - Morayfield
Query!
Recruitment postcode(s) [8]
0
0
4556 - Sippy Downs
Query!
Recruitment postcode(s) [9]
0
0
4068 - Taringa
Query!
Recruitment postcode(s) [10]
0
0
4121 - Tarragindi
Query!
Recruitment postcode(s) [11]
0
0
3000 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
Auckland
Query!
Country [2]
0
0
New Zealand
Query!
State/province [2]
0
0
Christchurch
Query!
Country [3]
0
0
New Zealand
Query!
State/province [3]
0
0
Hamilton
Query!
Country [4]
0
0
New Zealand
Query!
State/province [4]
0
0
Rotorua
Query!
Country [5]
0
0
Philippines
Query!
State/province [5]
0
0
Cavite
Query!
Country [6]
0
0
Philippines
Query!
State/province [6]
0
0
Iloilo City
Query!
Country [7]
0
0
Philippines
Query!
State/province [7]
0
0
Manila
Query!
Country [8]
0
0
Philippines
Query!
State/province [8]
0
0
Quezon
Query!
Country [9]
0
0
South Africa
Query!
State/province [9]
0
0
Johannesburg
Query!
Country [10]
0
0
South Africa
Query!
State/province [10]
0
0
Bellville
Query!
Country [11]
0
0
South Africa
Query!
State/province [11]
0
0
Bloemfontein
Query!
Country [12]
0
0
South Africa
Query!
State/province [12]
0
0
Cape Town
Query!
Country [13]
0
0
South Africa
Query!
State/province [13]
0
0
Mpumalanga
Query!
Country [14]
0
0
South Africa
Query!
State/province [14]
0
0
Paarl
Query!
Country [15]
0
0
South Africa
Query!
State/province [15]
0
0
Soweto
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Seqirus
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This Phase 2, randomized, observer-blind, antigen and adjuvant dose-ranging Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 800 subjects are to be randomized into 1 of 8 possible treatment groups. Immunogenicity and safety will be assessed in the overall study population (adults =50 years and above) and in the age subgroups =50-64 years and =65 years. Data from this study will be used to select the optimal dose to be tested in the pivotal Phase 3 immunogenicity and safety study in older adults. Disclosure Statement: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04782323
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Therapeutic Area Head
Query!
Address
0
0
Seqirus
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/23/NCT04782323/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/23/NCT04782323/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04782323
Download to PDF