Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782323
• Other study ID #: V201_01
• Status: Completed
• Phase: Phase 2
• Start date: April 13, 2021
• Est. completion date: March 3, 2022

Study information

• Verified date: September 2022
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 to determine the appropriate age population for this vaccine. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 839
• Est. completion date: March 3, 2022
• Est. primary completion date: September 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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) (see Appendix 2 - List of Adverse Events of Special Interest).

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 consent5.

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 (see Section 4.3, Criteria for Delay of Vaccination).

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• 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.
• 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.
• 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:
• 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.

Drug:
• 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.
• 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.
• 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.
• QII Active Comparator
Biological/Vaccine: Investigational QII 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.

Locations

Country	Name	City	State
Australia	03605 - PCRN_Paratus Clinical Research (Central Coast)	Blacktown	New South Wales
Australia	3610- Emeritis Research	Botany	New South Wales
Australia	3609 - Northern Beaches Clinical Research [NSW]	Brookvale	New South Wales
Australia	03607 - PCRN_Paratus Clinical Research	Bruce	Canberra
Australia	03602 - PCRN_Paratus Clinical Research,(Western Sydney) [NSW]	Kanwal	New South Wales
Australia	03608 - Australian Clinical Research Network - ACRN [NSW]	Maroubra	New South Wales
Australia	3611 - The University of Melbourne Peter Doherty Institute for Infection and Immunity	Melbourne	Victoria
Australia	03604 - University of the Sunshine Coast Clinical Trials Centre	Morayfield	Queensland
Australia	03603 - University of the Sunshine Coast	Sippy Downs	Queensland
Australia	03601 - AusTrials Taringa [QLD]	Taringa	Queensland
Australia	03606 - AusTrials Tarragindi (Aus Trial Wellers Hill)[QLD]	Tarragindi	Queensland
New Zealand	55406 - Optimal Clinical Trials	Auckland
New Zealand	55402- PCRN_Southern Clinical Trials Waitemata	Birkenhead	Auckland
New Zealand	55404- PCRN_Southern Clinical Trials Christchurch	Christchurch
New Zealand	55403-PCRN_Lakeland Clinical Trials Waikato	Hamilton
New Zealand	55401- PCRN_Southern Clinical Trials Totara	New Lynn	Auckland
New Zealand	55405 - PCRN_Lakeland Clinical Trials	Rotorua
Philippines	60801 - De La Salle Medical and Health Sciences Institute	Dasmariñas	Cavite
Philippines	60805 - Manila Doctors' Hospital	Ermita	Manila
Philippines	60802 - West Visayas University Medical Center	Jaro	Iloilo City
Philippines	60803 - Philippine General Hospital	Manila
Philippines	60804 - Quirino Memorial Medical Center	Quezon City	Quezon
South Africa	71005 South Africa Haylene71005 - Tiervlei Trial Centre -- Karl Bremer Hospital	Bellville
South Africa	71002 - JOSHA Research	Bloemfontein
South Africa	71011 - Farmovs	Bloemfontein
South Africa	71004 - Tread Research -- Tygerberg Hospital	Cape Town
South Africa	71006 - Mzansi Ethical Research Centre (MERC)	Mpumalanga
South Africa	71003- Newtown Clinical Research	Newtown	Johannesburg
South Africa	71009 - Be Part Yoluntu Centre	Paarl
South Africa	71001 - Wits Clinical Researc - Chris Hani Baragwanath Academic Hospital	Soweto

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Countries where clinical trial is conducted

Australia,  New Zealand,  Philippines,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure: 1. Immunogenicity Endpoint: Hemagglutination inhibition (HI) titers against vaccine A and B influenza strains		[28 days post-vaccination]