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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

Titles & IDs
Public title
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults
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
Secondary ID [1] 0 0
V201_01
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: 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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

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
Assessment method [1] 0 0
Timepoint [1] 0 0
[28 days post-vaccination]
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
Assessment method [2] 0 0
Timepoint [2] 0 0
28 days post-vaccination
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
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
Timepoint [3] 0 0
28 days post-vaccination
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)
Assessment method [4] 0 0
Timepoint [4] 0 0
28 days post-vaccination
Primary outcome [5] 0 0
Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions
Assessment method [5] 0 0
Percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination
Timepoint [5] 0 0
7 days post-vaccination
Primary outcome [6] 0 0
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
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
Timepoint [6] 0 0
28 days post-vaccination
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)
Assessment method [7] 0 0
Timepoint [7] 0 0
28 days post-vaccination
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
Assessment method [1] 0 0
Timepoint [1] 0 0
180 days post-vaccination
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
Assessment method [2] 0 0
Timepoint [2] 0 0
28 days post-vaccination
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
Assessment method [3] 0 0
Timepoint [3] 0 0
28 days post-vaccination
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
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
Timepoint [4] 0 0
28 days post-vaccination
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
Assessment method [5] 0 0
Timepoint [5] 0 0
180 days post-vaccination
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
Assessment method [6] 0 0
Timepoint [6] 0 0
180 days post-vaccination
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)
Assessment method [7] 0 0
Timepoint [7] 0 0
180 days post-vaccination
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
Assessment method [8] 0 0
Timepoint [8] 0 0
180 days post-vaccination
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
Assessment method [9] 0 0
Timepoint [9] 0 0
180 days post-vaccination

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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/03/2022
Sample size
Target
Accrual to date
Final
839
Recruitment in Australia
Recruitment state(s)
CanberraNSW,QLD,VIC
Recruitment hospital [1] 0 0
03607 - PCRN_Paratus Clinical Research - Bruce
Recruitment hospital [2] 0 0
03605 - PCRN_Paratus Clinical Research (Central Coast) - Blacktown
Recruitment hospital [3] 0 0
3610- Emeritis Research - Botany
Recruitment hospital [4] 0 0
3609 - Northern Beaches Clinical Research [NSW] - Brookvale
Recruitment hospital [5] 0 0
03602 - PCRN_Paratus Clinical Research,(Western Sydney) [NSW] - Kanwal
Recruitment hospital [6] 0 0
03608 - Australian Clinical Research Network - ACRN [NSW] - Maroubra
Recruitment hospital [7] 0 0
03604 - University of the Sunshine Coast Clinical Trials Centre - Morayfield
Recruitment hospital [8] 0 0
03603 - University of the Sunshine Coast - Sippy Downs
Recruitment hospital [9] 0 0
03601 - AusTrials Taringa [QLD] - Taringa
Recruitment hospital [10] 0 0
03606 - AusTrials Tarragindi (Aus Trial Wellers Hill)[QLD] - Tarragindi
Recruitment hospital [11] 0 0
3611 - The University of Melbourne Peter Doherty Institute for Infection and Immunity - Melbourne
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2019 - Botany
Recruitment postcode(s) [4] 0 0
2100 - Brookvale
Recruitment postcode(s) [5] 0 0
2259 - Kanwal
Recruitment postcode(s) [6] 0 0
2035 - Maroubra
Recruitment postcode(s) [7] 0 0
4506 - Morayfield
Recruitment postcode(s) [8] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [9] 0 0
4068 - Taringa
Recruitment postcode(s) [10] 0 0
4121 - Tarragindi
Recruitment postcode(s) [11] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Rotorua
Country [5] 0 0
Philippines
State/province [5] 0 0
Cavite
Country [6] 0 0
Philippines
State/province [6] 0 0
Iloilo City
Country [7] 0 0
Philippines
State/province [7] 0 0
Manila
Country [8] 0 0
Philippines
State/province [8] 0 0
Quezon
Country [9] 0 0
South Africa
State/province [9] 0 0
Johannesburg
Country [10] 0 0
South Africa
State/province [10] 0 0
Bellville
Country [11] 0 0
South Africa
State/province [11] 0 0
Bloemfontein
Country [12] 0 0
South Africa
State/province [12] 0 0
Cape Town
Country [13] 0 0
South Africa
State/province [13] 0 0
Mpumalanga
Country [14] 0 0
South Africa
State/province [14] 0 0
Paarl
Country [15] 0 0
South Africa
State/province [15] 0 0
Soweto

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seqirus
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Therapeutic Area Head
Address 0 0
Seqirus
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04782323