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

Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT04782323
Collaborator
(none)
839
Enrollment
30
Locations
8
Arms
10.6
Actual Duration (Months)
28
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: aQII-1
  • Drug: aQII-3 Investigational
  • Drug: aQII-6 Investigational
  • Other: aQII-7 Investigational
  • Drug: aQII-9 Investigational
  • Drug: aQII-10 Investigational
  • Drug: aQII-11 Investigational
  • Drug: QII Active Comparator
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
839 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded
Primary Purpose:
Prevention
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
Actual Study Start Date :
Apr 13, 2021
Actual Primary Completion Date :
Sep 22, 2021
Actual Study Completion Date :
Mar 3, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A aQII-1 Investigational

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.
Experimental: Group B aQII-3 Investigational

Drug: 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.
Experimental: Group C aQII-6 Investigational

Drug: 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.
Experimental: Group D aQII-7 Investigational

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.
Experimental: Group E aQII-9 Investigational

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.
Experimental: Group F aQII-10 Investigational

Drug: 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.
Experimental: Group G aQII-11 Investigational

Drug: 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.
Active Comparator: Group H QII Active Comparator

Drug: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

  8. Clinical conditions.

  9. 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.

  10. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.

  11. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.

  12. Receipt of an investigational or non-registered medicinal product within 30 days prior to vaccination.

  13. 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.

  14. Study personnel or immediate family or household member of study personnel.

  15. 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.

  16. Acute (severe) febrile illness (see Section 4.3, Criteria for Delay of Vaccination).

  17. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 03607 - PCRN_Paratus Clinical Research Bruce Canberra Australia 2617
2 03605 - PCRN_Paratus Clinical Research (Central Coast) Blacktown New South Wales Australia 2148
3 3610- Emeritis Research Botany New South Wales Australia 2019
4 3609 - Northern Beaches Clinical Research [NSW] Brookvale New South Wales Australia 2100
5 03602 - PCRN_Paratus Clinical Research,(Western Sydney) [NSW] Kanwal New South Wales Australia 2259
6 03608 - Australian Clinical Research Network - ACRN [NSW] Maroubra New South Wales Australia 2035
7 03604 - University of the Sunshine Coast Clinical Trials Centre Morayfield Queensland Australia 4506
8 03603 - University of the Sunshine Coast Sippy Downs Queensland Australia 4556
9 03601 - AusTrials Taringa [QLD] Taringa Queensland Australia 4068
10 03606 - AusTrials Tarragindi (Aus Trial Wellers Hill)[QLD] Tarragindi Queensland Australia 4121
11 3611 - The University of Melbourne Peter Doherty Institute for Infection and Immunity Melbourne Victoria Australia 3000
12 55402- PCRN_Southern Clinical Trials Waitemata Birkenhead Auckland New Zealand 0626
13 55401- PCRN_Southern Clinical Trials Totara New Lynn Auckland New Zealand 0600
14 55406 - Optimal Clinical Trials Auckland New Zealand 1010
15 55404- PCRN_Southern Clinical Trials Christchurch Christchurch New Zealand 8013
16 55403-PCRN_Lakeland Clinical Trials Waikato Hamilton New Zealand 3200
17 55405 - PCRN_Lakeland Clinical Trials Rotorua New Zealand 3010
18 60801 - De La Salle Medical and Health Sciences Institute Dasmariñas Cavite Philippines 4114
19 60802 - West Visayas University Medical Center Jaro Iloilo City Philippines 5000
20 60805 - Manila Doctors' Hospital Ermita Manila Philippines 1000
21 60804 - Quirino Memorial Medical Center Quezon City Quezon Philippines 1109
22 60803 - Philippine General Hospital Manila Philippines 1000
23 71003- Newtown Clinical Research Newtown Johannesburg South Africa 2113
24 71005 South Africa Haylene71005 - Tiervlei Trial Centre -- Karl Bremer Hospital Bellville South Africa 7531
25 71002 - JOSHA Research Bloemfontein South Africa 9301
26 71011 - Farmovs Bloemfontein South Africa 9301
27 71004 - Tread Research -- Tygerberg Hospital Cape Town South Africa 7505
28 71006 - Mzansi Ethical Research Centre (MERC) Mpumalanga South Africa 1050
29 71009 - Be Part Yoluntu Centre Paarl South Africa 7626
30 71001 - Wits Clinical Researc - Chris Hani Baragwanath Academic Hospital Soweto South Africa 2013

Sponsors and Collaborators

  • Seqirus

Investigators

  • Study Chair: Therapeutic Area Head, Seqirus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT04782323
Other Study ID Numbers:
  • V201_01
First Posted:
Mar 4, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Influenza, Human

Study Results

No Results Posted as of Aug 18, 2022