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

NCT04782323 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: V201_01
• Study Type: interventional
• Target: 839
• Locations: 4 countries
• Sites: 30

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (7)

• 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

  [28 days post-vaccination]

• 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

  28 days post-vaccination

• 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

  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

  28 days post-vaccination

• Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)

  28 days post-vaccination

• Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions

  Percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination

  7 days post-vaccination

• Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events

  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

  28 days post-vaccination

• 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)

  28 days post-vaccination

Secondary Outcomes (9)

• 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

  180 days post-vaccination

• Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay

  28 days post-vaccination

• 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

  28 days post-vaccination

• Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay

  28 days post-vaccination

• Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay

  180 days post-vaccination

Study Arms (8)

Group A aQII-1 Investigational

EXPERIMENTAL

Drug: aQII-1

Group B aQII-3 Investigational

EXPERIMENTAL

Drug: aQII-3 Investigational

Group C aQII-6 Investigational

EXPERIMENTAL

Drug: aQII-6 Investigational

Group D aQII-7 Investigational

EXPERIMENTAL

Other: aQII-7 Investigational

Group E aQII-9 Investigational

EXPERIMENTAL

Drug: aQII-9 Investigational

Group F aQII-10 Investigational

EXPERIMENTAL

Drug: aQII-10 Investigational

Group G aQII-11 Investigational

EXPERIMENTAL

Drug: aQII-11 Investigational

Group H Licensed QII Active Comparator

ACTIVE COMPARATOR

Drug: Licensed QII Active Comparator

Interventions

aQII-1 DRUG

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.

Group A aQII-1 Investigational

aQII-3 Investigational DRUG

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.

Group B aQII-3 Investigational

aQII-6 Investigational DRUG

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.

Group C aQII-6 Investigational

aQII-7 Investigational OTHER

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.

Group D aQII-7 Investigational

aQII-9 Investigational DRUG

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.

Group E aQII-9 Investigational

aQII-10 Investigational DRUG

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.

Group F aQII-10 Investigational

aQII-11 Investigational DRUG

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.

Group G aQII-11 Investigational

Licensed QII Active Comparator DRUG

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.

Group H Licensed QII Active Comparator

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals ≥50 years of age on the day of informed consent.
• 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.
• Individuals who can comply with study procedures including follow-up .
• 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.

You may not qualify if:

• 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.
• Progressive, unstable or uncontrolled clinical conditions.
• Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
• History of any medical condition considered an adverse event of special interest (AESI).
• Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
• Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.
• Abnormal function of the immune system resulting from:
• Clinical conditions.
• 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.
• Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
• Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
• Receipt of an investigational or non-registered medicinal product within 30 days prior to vaccination.
• 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.
• Study personnel or immediate family or household member of study personnel.
• 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.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (30)

03607 - PCRN_Paratus Clinical Research

Bruce, Australian Capital Territory, 2617, Australia

Location

03605 - PCRN_Paratus Clinical Research (Central Coast)

Blacktown, New South Wales, 2148, Australia

Location

3610- Emeritis Research

Botany, New South Wales, 2019, Australia

Location

3609 - Northern Beaches Clinical Research [NSW]

Brookvale, New South Wales, 2100, Australia

Location

03602 - PCRN_Paratus Clinical Research,(Western Sydney) [NSW]

Kanwal, New South Wales, 2259, Australia

Location

03608 - Australian Clinical Research Network - ACRN [NSW]

Maroubra, New South Wales, 2035, Australia

Location

03604 - University of the Sunshine Coast Clinical Trials Centre

Morayfield, Queensland, 4506, Australia

Location

03603 - University of the Sunshine Coast

Sippy Downs, Queensland, 4556, Australia

Location

03601 - AusTrials Taringa [QLD]

Taringa, Queensland, 4068, Australia

Location

03606 - AusTrials Tarragindi (Aus Trial Wellers Hill)[QLD]

Tarragindi, Queensland, 4121, Australia

Location

3611 - The University of Melbourne Peter Doherty Institute for Infection and Immunity

Melbourne, Victoria, 3000, Australia

Location

55402- PCRN_Southern Clinical Trials Waitemata

Birkenhead, Auckland, 0626, New Zealand

Location

55401- PCRN_Southern Clinical Trials Totara

New Lynn, Auckland, 0600, New Zealand

Location

55406 - Optimal Clinical Trials

Auckland, 1010, New Zealand

Location

55404- PCRN_Southern Clinical Trials Christchurch

Christchurch, 8013, New Zealand

Location

55403-PCRN_Lakeland Clinical Trials Waikato

Hamilton, 3200, New Zealand

Location

55405 - PCRN_Lakeland Clinical Trials

Rotorua, 3010, New Zealand

Location

60801 - De La Salle Medical and Health Sciences Institute

Dasmariñas, Cavite, 4114, Philippines

Location

60802 - West Visayas University Medical Center

Jaro, Iloilo City, 5000, Philippines

Location

60805 - Manila Doctors' Hospital

Ermita, Manila, 1000, Philippines

Location

60804 - Quirino Memorial Medical Center

Quezon City, Quezon, 1109, Philippines

Location

60803 - Philippine General Hospital

Manila, 1000, Philippines

Location

71003- Newtown Clinical Research

Newtown, Johannesburg, 2113, South Africa

Location

71005 South Africa Haylene71005 - Tiervlei Trial Centre -- Karl Bremer Hospital

Bellville, 7531, South Africa

Location

71002 - JOSHA Research

Bloemfontein, 9301, South Africa

Location

71011 - Farmovs

Bloemfontein, 9301, South Africa

Location

71004 - Tread Research -- Tygerberg Hospital

Cape Town, 7505, South Africa

Location

71006 - Mzansi Ethical Research Centre (MERC)

Mpumalanga, 1050, South Africa

Location

71009 - Be Part Yoluntu Centre

Paarl, 7626, South Africa

Location

71001 - Wits Clinical Researc - Chris Hani Baragwanath Academic Hospital

Soweto, 2013, South Africa

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Seqirus Clinical Trial Manager
• Organization: Seqirus

seqirus.clinicaltrials@Seqirus.com

1-855-358-8966

Study Officials

• Therapeutic Area Head

  Seqirus

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: April 13, 2021
• Primary Completion: September 22, 2021
• Study Completion: March 3, 2022
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Time Frame: SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
• Access Criteria: SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication

Locations

PH (5); ZA (8); AU (11); NZ (6)