Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults
- Conditions
- Influenza
- Interventions
- Drug: aQII-1Drug: aQII-3 InvestigationalDrug: aQII-6 InvestigationalDrug: aQII-9 InvestigationalOther: aQII-7 InvestigationalDrug: aQII-11 InvestigationalDrug: Licensed QII Active ComparatorDrug: aQII-10 Investigational
- Registration Number
- NCT04782323
- Lead Sponsor
- Seqirus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 839
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A aQII-1 Investigational aQII-1 - Group B aQII-3 Investigational aQII-3 Investigational - Group C aQII-6 Investigational aQII-6 Investigational - Group E aQII-9 Investigational aQII-9 Investigational - Group D aQII-7 Investigational aQII-7 Investigational - Group G aQII-11 Investigational aQII-11 Investigational - Group H Licensed QII Active Comparator Licensed QII Active Comparator - Group F aQII-10 Investigational aQII-10 Investigational -
- Primary Outcome Measures
Name Time Method 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 28 days post-vaccination 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
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 7 days post-vaccination Percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events 28 days post-vaccination 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 investigatorSafety 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 Outcome Measures
Name Time Method 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 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
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 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 180 days post-vaccination Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) 180 days post-vaccination Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay 180 days post-vaccination 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 180 days post-vaccination
Trial Locations
- Locations (30)
03604 - University of the Sunshine Coast Clinical Trials Centre
🇦🇺Morayfield, Queensland, Australia
03603 - University of the Sunshine Coast
🇦🇺Sippy Downs, Queensland, Australia
03606 - AusTrials Tarragindi (Aus Trial Wellers Hill)[QLD]
🇦🇺Tarragindi, Queensland, Australia
55406 - Optimal Clinical Trials
🇳🇿Auckland, New Zealand
55403-PCRN_Lakeland Clinical Trials Waikato
🇳🇿Hamilton, New Zealand
60805 - Manila Doctors' Hospital
🇵🇭Ermita, Manila, Philippines
03605 - PCRN_Paratus Clinical Research (Central Coast)
🇦🇺Blacktown, New South Wales, Australia
03607 - PCRN_Paratus Clinical Research
🇦🇺Bruce, Canberra, Australia
3610- Emeritis Research
🇦🇺Botany, New South Wales, Australia
03602 - PCRN_Paratus Clinical Research,(Western Sydney) [NSW]
🇦🇺Kanwal, New South Wales, Australia
3609 - Northern Beaches Clinical Research [NSW]
🇦🇺Brookvale, New South Wales, Australia
03608 - Australian Clinical Research Network - ACRN [NSW]
🇦🇺Maroubra, New South Wales, Australia
03601 - AusTrials Taringa [QLD]
🇦🇺Taringa, Queensland, Australia
3611 - The University of Melbourne Peter Doherty Institute for Infection and Immunity
🇦🇺Melbourne, Victoria, Australia
55402- PCRN_Southern Clinical Trials Waitemata
🇳🇿Birkenhead, Auckland, New Zealand
55401- PCRN_Southern Clinical Trials Totara
🇳🇿New Lynn, Auckland, New Zealand
60802 - West Visayas University Medical Center
🇵🇭Jaro, Iloilo City, Philippines
55404- PCRN_Southern Clinical Trials Christchurch
🇳🇿Christchurch, New Zealand
55405 - PCRN_Lakeland Clinical Trials
🇳🇿Rotorua, New Zealand
60801 - De La Salle Medical and Health Sciences Institute
🇵🇭Dasmariñas, Cavite, Philippines
60803 - Philippine General Hospital
🇵🇭Manila, Philippines
60804 - Quirino Memorial Medical Center
🇵🇭Quezon City, Quezon, Philippines
71003- Newtown Clinical Research
🇿🇦Newtown, Johannesburg, 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
71009 - Be Part Yoluntu Centre
🇿🇦Paarl, South Africa
71001 - Wits Clinical Researc - Chris Hani Baragwanath Academic Hospital
🇿🇦Soweto, South Africa