Clinical trial NCT04782323: Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2021-03-04
Enrollment: 839
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: [28 days post-vaccination]
measure: 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
timeFrame: 28 days post-vaccination
measure: 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
timeFrame: 28 days post-vaccination
measure: Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
timeFrame: 28 days post-vaccination
measure: Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions
timeFrame: 7 days post-vaccination
measure: Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
timeFrame: 28 days post-vaccination
measure: 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)
timeFrame: 28 days post-vaccination
Secondary outcomes:
measure: 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
timeFrame: 180 days post-vaccination
measure: Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
timeFrame: 28 days post-vaccination
measure: 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
timeFrame: 28 days post-vaccination
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay
timeFrame: 28 days post-vaccination
measure: Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
timeFrame: 180 days post-vaccination
measure: 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
timeFrame: 180 days post-vaccination
measure: Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
timeFrame: 180 days post-vaccination
measure: Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
timeFrame: 180 days post-vaccination
measure: 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
timeFrame: 180 days post-vaccination
Other outcomes:
Locations:
city: Bruce
country: Australia
facility: 03607 - PCRN_Paratus Clinical Research
state: Canberra
city: Blacktown
country: Australia
facility: 03605 - PCRN_Paratus Clinical Research (Central Coast)
state: New South Wales
city: Botany
country: Australia
facility: 3610- Emeritis Research
state: New South Wales
city: Brookvale
country: Australia
facility: 3609 - Northern Beaches Clinical Research [NSW]
state: New South Wales
city: Kanwal
country: Australia
facility: 03602 - PCRN_Paratus Clinical Research,(Western Sydney) [NSW]
state: New South Wales
city: Maroubra
country: Australia
facility: 03608 - Australian Clinical Research Network - ACRN [NSW]
state: New South Wales
city: Morayfield
country: Australia
facility: 03604 - University of the Sunshine Coast Clinical Trials Centre
state: Queensland
city: Sippy Downs
country: Australia
facility: 03603 - University of the Sunshine Coast
state: Queensland
city: Taringa
country: Australia
facility: 03601 - AusTrials Taringa [QLD]
state: Queensland
city: Tarragindi
country: Australia
facility: 03606 - AusTrials Tarragindi (Aus Trial Wellers Hill)[QLD]
state: Queensland
city: Melbourne
country: Australia
facility: 3611 - The University of Melbourne Peter Doherty Institute for Infection and Immunity
state: Victoria
city: Birkenhead
country: New Zealand
facility: 55402- PCRN_Southern Clinical Trials Waitemata
state: Auckland
city: New Lynn
country: New Zealand
facility: 55401- PCRN_Southern Clinical Trials Totara
state: Auckland
city: Auckland
country: New Zealand
facility: 55406 - Optimal Clinical Trials
city: Christchurch
country: New Zealand
facility: 55404- PCRN_Southern Clinical Trials Christchurch
city: Hamilton
country: New Zealand
facility: 55403-PCRN_Lakeland Clinical Trials Waikato
city: Rotorua
country: New Zealand
facility: 55405 - PCRN_Lakeland Clinical Trials
city: Dasmariñas
country: Philippines
facility: 60801 - De La Salle Medical and Health Sciences Institute
state: Cavite
city: Jaro
country: Philippines
facility: 60802 - West Visayas University Medical Center
state: Iloilo City
city: Ermita
country: Philippines
facility: 60805 - Manila Doctors' Hospital
state: Manila
city: Quezon City
country: Philippines
facility: 60804 - Quirino Memorial Medical Center
state: Quezon
city: Manila
country: Philippines
facility: 60803 - Philippine General Hospital
city: Newtown
country: South Africa
facility: 71003- Newtown Clinical Research
state: Johannesburg
city: Bellville
country: South Africa
facility: 71005 South Africa Haylene71005 - Tiervlei Trial Centre -- Karl Bremer Hospital
city: Bloemfontein
country: South Africa
facility: 71002 - JOSHA Research
city: Bloemfontein
country: South Africa
facility: 71011 - Farmovs
city: Cape Town
country: South Africa
facility: 71004 - Tread Research -- Tygerberg Hospital
city: Mpumalanga
country: South Africa
facility: 71006 - Mzansi Ethical Research Centre (MERC)
city: Paarl
country: South Africa
facility: 71009 - Be Part Yoluntu Centre
city: Soweto
country: South Africa
facility: 71001 - Wits Clinical Researc - Chris Hani Baragwanath Academic Hospital
Study officials:
affiliation: Seqirus
name: Therapeutic Area Head
role: STUDY_CHAIR
References: