Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04782323
Other study ID # V201_01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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]
See also
  Status Clinical Trial Phase
Completed NCT05523089 - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults Phase 2
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03282240 - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US Phase 3
Completed NCT00968539 - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00971425 - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) Phase 3
Completed NCT00968526 - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam Phase 3
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 1
Completed NCT04109222 - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively Phase 4
Completed NCT02587221 - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age Phase 3
Completed NCT03453801 - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Phase 1
Completed NCT01440387 - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older Phase 3
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT00972517 - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children Phase 3
Completed NCT04570904 - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting NCT03331991 - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel N/A