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
| Registry | NCT04782323 |
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| Status | Completed |
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| Phase | Phase 2 |
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| Study type | Interventional; randomized, parallel, masking: triple, prevention |
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| Enrollment | 839 (Actual) |
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| Sponsor | Seqirus (Industry) |
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| Conditions | Influenza |
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| Interventions | aQII-1, aQII-3 Investigational, aQII-6 Investigational, aQII-7 Investigational, aQII-9 Investigational, aQII-10 Investigational, aQII-11 Investigational, Licensed QII Active Comparator (Drug, other) |
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| Dates | start 2021-04-13, primary completion 2021-09-22, completion 2022-03-03, first posted 2021-03-04, last updated 2024-10-10 |
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| Locations | 30 sites in Australia, New Zealand, Philippines, South Africa |
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Related Papers Related Patents Related Grants Related Experts
All trials for Influenza All trials of aQII-1 All trials of aQII-3 Investigational
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| 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 | |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
+Outcome measures
Primary outcomes
- 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 investigator
- 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
- 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]
+Eligibility
Sex: All, ages: 50 Years to any, accepts healthy volunteers
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).
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 consent.
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.
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.
+Posted results
Participant flow
| Milestone | Group H Licensed QII Active Comparator | Group A aQII-1 Investigational | Group E aQII-9 Investigational | Group C aQII-6 Investigational | Group F aQII-10 Investigational | Group B aQII-3 Investigational | Group D aQII-7 Investigational | Group G aQII-11 Investigational |
|---|
| Started | 98 | 107 | 107 | 103 | 106 | 108 | 101 | 109 |
| Completed | 96 | 106 | 105 | 103 | 105 | 105 | 99 | 106 |
| Not completed | 2 | 1 | 2 | 0 | 1 | 3 | 2 | 3 |
Outcome results
- 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 (Primary), Geometric mean, titer: Group H Licensed QII Active Comparator 42.31 (34.3 to 52.2); Group A aQII-1 Investigational 40.39 (33.1 to 49.3); Group E aQII-9 Investigational 48.29 (39.6 to 58.9); Group C aQII-6 Investigational 49.31 (40.1 to 60.6); Group F aQII-10 Investigational 46.19 (37.7 to 56.6); Group B aQII-3 Investigational 47.50 (38.9 to 58.1); Group D aQII-7 Investigational 46.92 (38.0 to 57.9); Group G aQII-11 Investigational 37.24 (30.5 to 45.5)
- 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 (Primary), Geometric mean, Ratio: Group A aQII-1 Investigational 0.77 (0.56 to 1.06); Group E aQII-9 Investigational 0.88 (0.64 to 1.20); Group C aQII-6 Investigational 0.99 (0.72 to 1.36); Group F aQII-10 Investigational 0.98 (0.71 to 1.35); Group B aQII-3 Investigational 1.07 (0.78 to 1.46); Group D aQII-7 Investigational 1.19 (0.86 to 1.64); Group G aQII-11 Investigational 0.97 (0.70 to 1.33)
- 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 (Primary), Number, percentage of subjects: Group H Licensed QII Active Comparator 55.8 (45.2 to 66.0); Group A aQII-1 Investigational 53.3 (43.3 to 63.1); Group E aQII-9 Investigational 51.9 (42.0 to 61.7); Group C aQII-6 Investigational 54.5 (44.2 to 64.6); Group F aQII-10 Investigational 57.8 (47.7 to 67.6); Group B aQII-3 Investigational 58.7 (48.6 to 68.2); Group D aQII-7 Investigational 60.0 (49.4 to 69.9); Group G aQII-11 Investigational 57.7 (47.6 to 67.3)
- Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) (Primary), Number, percentage of subjects: Group H Licensed QII Active Comparator 66.3 (55.9 to 75.7); Group A aQII-1 Investigational 60.0 (50.0 to 69.4); Group E aQII-9 Investigational 67.9 (58.2 to 76.7); Group C aQII-6 Investigational 71.7 (61.8 to 80.3); Group F aQII-10 Investigational 68.6 (58.7 to 77.5); Group B aQII-3 Investigational 66.3 (56.4 to 75.3); Group D aQII-7 Investigational 66.3 (55.9 to 75.7); Group G aQII-11 Investigational 51.0 (41.0 to 60.9)
- Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions (Primary), Count of participants, Participants: Group H Licensed QII Active Comparator 44; Group A aQII-1 Investigational 69; Group E aQII-9 Investigational 71; Group C aQII-6 Investigational 76; Group F aQII-10 Investigational 85; Group B aQII-3 Investigational 73; Group D aQII-7 Investigational 60; Group G aQII-11 Investigational 82
- Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events (Primary), Count of participants, Participants: Group H Licensed QII Active Comparator 29; Group A aQII-1 Investigational 27; Group E aQII-9 Investigational 26; Group C aQII-6 Investigational 30; Group F aQII-10 Investigational 32; Group B aQII-3 Investigational 26; Group D aQII-7 Investigational 30; Group G aQII-11 Investigational 30
- 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) (Primary), Count of participants, Participants: Group H Licensed QII Active Comparator 4; Group A aQII-1 Investigational 0; Group E aQII-9 Investigational 1; Group C aQII-6 Investigational 1; Group F aQII-10 Investigational 0; Group B aQII-3 Investigational 0; Group D aQII-7 Investigational 0; Group G aQII-11 Investigational 0
- 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 (Secondary), Count of participants, Participants: Group H Licensed QII Active Comparator 8; Group A aQII-1 Investigational 1; Group E aQII-9 Investigational 1; Group C aQII-6 Investigational 3; Group F aQII-10 Investigational 5; Group B aQII-3 Investigational 3; Group D aQII-7 Investigational 2; Group G aQII-11 Investigational 2
- Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay (Secondary), Geometric mean, titer: Group H Licensed QII Active Comparator 44.55 (34.6 to 57.4); Group A aQII-1 Investigational 29.77 (23.4 to 37.9); Group E aQII-9 Investigational 31.77 (25.0 to 40.3); Group C aQII-6 Investigational 39.02 (30.4 to 50.0); Group F aQII-10 Investigational 32.29 (25.3 to 41.2); Group B aQII-3 Investigational 32.99 (25.9 to 42.0); Group D aQII-7 Investigational 30.44 (23.6 to 39.2); Group G aQII-11 Investigational 32.49 (25.5 to 41.4)
- 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 (Secondary), Geometric mean, Ratio: Group A aQII-1 Investigational 1.04 (0.68 to 1.58); Group E aQII-9 Investigational 0.90 (0.59 to 1.37); Group C aQII-6 Investigational 1.25 (0.82 to 1.91); Group F aQII-10 Investigational 1.39 (0.91 to 2.11); Group B aQII-3 Investigational 1.33 (0.87 to 2.03); Group D aQII-7 Investigational 1.53 (1.00 to 2.35); Group G aQII-11 Investigational 0.98 (0.64 to 1.49)
- Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay (Secondary), Number, percentage of subjects: Group H Licensed QII Active Comparator 73.7 (63.6 to 82.2); Group A aQII-1 Investigational 82.9 (74.3 to 89.5); Group E aQII-9 Investigational 82.1 (73.4 to 88.8); Group C aQII-6 Investigational 79.8 (70.5 to 87.2); Group F aQII-10 Investigational 87.3 (79.2 to 93.0); Group B aQII-3 Investigational 83.7 (75.1 to 90.2); Group D aQII-7 Investigational 87.4 (79.0 to 93.3); Group G aQII-11 Investigational 87.5 (79.6 to 93.2)
- Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay (Secondary), Geometric mean, titer: Group H Licensed QII Active Comparator 110.69 (89.3 to 137.2); Group A aQII-1 Investigational 95.07 (77.7 to 116.3); Group E aQII-9 Investigational 78.87 (64.4 to 96.5); Group C aQII-6 Investigational 86.67 (70.3 to 106.8); Group F aQII-10 Investigational 92.45 (75.3 to 113.5); Group B aQII-3 Investigational 78.23 (63.4 to 96.6); Group D aQII-7 Investigational 85.50 (69.0 to 105.9); Group G aQII-11 Investigational 86.67 (70.6 to 106.5)
- 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 (Secondary), Geometric mean, Ratio: Group A aQII-1 Investigational 0.86 (0.64 to 1.15); Group E aQII-9 Investigational 0.71 (0.53 to 0.96); Group C aQII-6 Investigational 0.78 (0.58 to 1.05); Group F aQII-10 Investigational 0.84 (0.62 to 1.12); Group B aQII-3 Investigational 0.71 (0.52 to 0.95); Group D aQII-7 Investigational 0.77 (0.57 to 1.04); Group G aQII-11 Investigational 0.78 (0.58 to 1.05)
- Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) (Secondary), Number, percentage: Group H Licensed QII Active Comparator 87.2 (78.8 to 93.2); Group A aQII-1 Investigational 85.8 (77.7 to 91.9); Group E aQII-9 Investigational 80.0 (71.1 to 87.2); Group C aQII-6 Investigational 82.8 (73.9 to 89.7); Group F aQII-10 Investigational 87.3 (79.2 to 93.0); Group B aQII-3 Investigational 80.4 (71.1 to 87.8); Group D aQII-7 Investigational 83.0 (73.8 to 89.9); Group G aQII-11 Investigational 81.4 (72.4 to 88.4)
- Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay (Secondary), Geometric mean, titer: Group H Licensed QII Active Comparator 516.06 (382.5 to 696.2); Group A aQII-1 Investigational 529.64 (399.8 to 701.7); Group E aQII-9 Investigational 427.95 (322.9 to 567.2); Group C aQII-6 Investigational 615.44 (459.8 to 823.7); Group F aQII-10 Investigational 562.64 (422.6 to 749.1); Group B aQII-3 Investigational 518.67 (386.8 to 695.5); Group D aQII-7 Investigational 644.81 (478.4 to 869.0); Group G aQII-11 Investigational 493.66 (370.8 to 657.3)
- 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 (Secondary), Geometric mean, Ratio: Group A aQII-1 Investigational 1.03 (0.68 to 1.55); Group E aQII-9 Investigational 0.83 (0.55 to 1.25); Group C aQII-6 Investigational 1.19 (0.79 to 1.81); Group F aQII-10 Investigational 1.09 (0.72 to 1.65); Group B aQII-3 Investigational 1.01 (0.66 to 1.53); Group D aQII-7 Investigational 1.25 (0.82 to 1.90); Group G aQII-11 Investigational 0.96 (0.63 to 1.45)
Adverse events
Time frame: Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Group H Licensed QII Active Comparator | 1/97 (1.0%) | 8/97 (8.2%) | 55/97 (56.7%) |
| Group A aQII-1 Investigational | 0/107 (0.0%) | 1/107 (0.9%) | 74/107 (69.2%) |
| Group E aQII-9 Investigational | 0/108 (0.0%) | 1/108 (0.9%) | 80/108 (74.1%) |
| Group C aQII-6 Investigational | 0/103 (0.0%) | 3/103 (2.9%) | 79/103 (76.7%) |
| Group F aQII-10 Investigational | 1/106 (0.9%) | 5/106 (4.7%) | 91/106 (85.8%) |
| Group B aQII-3 Investigational | 1/107 (0.9%) | 3/107 (2.8%) | 81/107 (75.7%) |
| Group D aQII-7 Investigational | 1/101 (1.0%) | 2/101 (2.0%) | 72/101 (71.3%) |
| Group G aQII-11 Investigational | 0/109 (0.0%) | 2/109 (1.8%) | 89/109 (81.7%) |
Serious adverse events by term
| Term | Organ system | Group H Licensed QII Active Comparator | Group A aQII-1 Investigational | Group E aQII-9 Investigational | Group C aQII-6 Investigational | Group F aQII-10 Investigational | Group B aQII-3 Investigational | Group D aQII-7 Investigational | Group G aQII-11 Investigational |
|---|
| retinal detachment | Eye disorders | 0/97 | 0/107 | 0/108 | 0/103 | 1/106 | 0/107 | 0/101 | 0/109 |
| intestinal obstruction | Gastrointestinal disorders | 0/97 | 0/107 | 0/108 | 1/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| death | General disorders | 0/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 1/101 | 0/109 |
| biliary colic | Hepatobiliary disorders | 0/97 | 0/107 | 1/108 | 0/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| cholecystitis acute | Hepatobiliary disorders | 0/97 | 0/107 | 0/108 | 1/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| drug hypersensitivity | Immune system disorders | 1/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| pneumonia | Infections and infestations | 0/97 | 0/107 | 0/108 | 0/103 | 1/106 | 0/107 | 1/101 | 0/109 |
| appendicitis | Infections and infestations | 1/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| cellulitis | Infections and infestations | 0/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 1/109 |
| diverticulitis | Infections and infestations | 0/97 | 0/107 | 0/108 | 1/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| pyelonephritis | Infections and infestations | 1/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| sepsis | Infections and infestations | 0/97 | 0/107 | 0/108 | 0/103 | 0/106 | 1/107 | 0/101 | 0/109 |
| ankle fracture | Injury, poisoning and procedural complications | 0/97 | 0/107 | 0/108 | 0/103 | 0/106 | 1/107 | 0/101 | 0/109 |
| bone contusion | Injury, poisoning and procedural complications | 0/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 1/109 |
| face injury | Injury, poisoning and procedural complications | 0/97 | 0/107 | 0/108 | 0/103 | 1/106 | 0/107 | 0/101 | 0/109 |
| skin laceration | Injury, poisoning and procedural complications | 0/97 | 0/107 | 0/108 | 0/103 | 0/106 | 1/107 | 0/101 | 0/109 |
| hypoglycaemia | Metabolism and nutrition disorders | 1/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| arthralgia | Musculoskeletal and connective tissue disorders | 1/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | 0/97 | 0/107 | 0/108 | 0/103 | 1/106 | 0/107 | 0/101 | 0/109 |
| adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/97 | 0/107 | 0/108 | 1/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/97 | 1/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 0/109 |
| syncope | Nervous system disorders | 0/97 | 0/107 | 0/108 | 0/103 | 1/106 | 0/107 | 0/101 | 0/109 |
| hypertension | Vascular disorders | 1/97 | 0/107 | 0/108 | 0/103 | 0/106 | 0/107 | 0/101 | 0/109 |
Other adverse events by term
| Term | Organ system | Group H Licensed QII Active Comparator | Group A aQII-1 Investigational | Group E aQII-9 Investigational | Group C aQII-6 Investigational | Group F aQII-10 Investigational | Group B aQII-3 Investigational | Group D aQII-7 Investigational | Group G aQII-11 Investigational |
|---|
| nausea | Gastrointestinal disorders | 7/97 | 8/107 | 10/108 | 12/103 | 19/106 | 9/107 | 10/101 | 16/109 |
| chills | General disorders | 8/97 | 6/107 | 9/108 | 10/103 | 18/106 | 10/107 | 13/101 | 20/109 |
| fatigue | General disorders | 25/97 | 25/107 | 34/108 | 36/103 | 41/106 | 27/107 | 31/101 | 47/109 |
| induration | General disorders | 1/97 | 9/107 | 10/108 | 7/103 | 14/106 | 9/107 | 10/101 | 15/109 |
| injection site pain | General disorders | 29/97 | 53/107 | 61/108 | 66/103 | 70/106 | 53/107 | 53/101 | 71/109 |
| upper respiratory tract infection | Infections and infestations | 1/97 | 8/107 | 4/108 | 4/103 | 6/106 | 5/107 | 5/101 | 4/109 |
| loss of appetite | Metabolism and nutrition disorders | 4/97 | 11/107 | 8/108 | 14/103 | 14/106 | 6/107 | 9/101 | 21/109 |
| arthralgia | Musculoskeletal and connective tissue disorders | 12/97 | 19/107 | 19/108 | 21/103 | 33/106 | 25/107 | 22/101 | 25/109 |
| myalgia | Musculoskeletal and connective tissue disorders | 13/97 | 16/107 | 20/108 | 24/103 | 34/106 | 24/107 | 19/101 | 27/109 |
| headache | Nervous system disorders | 18/97 | 27/107 | 28/108 | 30/103 | 42/106 | 31/107 | 29/101 | 39/109 |
| erythema | Skin and subcutaneous tissue disorders | 1/97 | 3/107 | 9/108 | 7/103 | 12/106 | 10/107 | 9/101 | 18/109 |
+Locations (30)
| Facility | City | Country | Status |
|---|
| 03607 - PCRN_Paratus Clinical Research | Bruce, Australian Capital Territory | 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 | |
| 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 | |
| 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 | 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 | |
| 55406 - Optimal Clinical Trials | Auckland | New Zealand | |
| 55404- PCRN_Southern Clinical Trials Christchurch | Christchurch | New Zealand | |
| 55403-PCRN_Lakeland Clinical Trials Waikato | Hamilton | New Zealand | |
| 55405 - PCRN_Lakeland Clinical Trials | Rotorua | New Zealand | |
| 60801 - De La Salle Medical and Health Sciences Institute | Dasmariñas, Cavite | Philippines | |
| 60802 - West Visayas University Medical Center | Jaro, Iloilo City | Philippines | |
| 60805 - Manila Doctors' Hospital | Ermita, Manila | Philippines | |
| 60804 - Quirino Memorial Medical Center | Quezon City, Quezon | Philippines | |
| 60803 - Philippine General Hospital | Manila | 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 | |
+Study documents
+Investigators
- Therapeutic Area Head, Study chair, Seqirus