Profylaxis for Influenza virus MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Quadrivalent Influenza Vaccine cell-based (QIVc)
Product Code: QIVc
Pharmaceutical Form: Suspension for injection in pre-filled syringe
IN
Sponsors
Seqirus UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females =2 years to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Individual with clinical signs of fever and/or an oral temperature of = 100.4 F (38.0 degrees Celsius) within three days prior to vaccination; 2. Individuals with a known history of any anaphylaxis, serious vaccine reactions or hypersensitivity to any of the vaccine components described in investigator brochure, or having any of the contraindications listed in the package insert of the comparator vaccine; 3. Individuals with history of Guillain-Barré syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis; 4. Female subject “of childbearing potential”, sexually active, and not used any of the “acceptable contraceptive method” for at least 2 months prior to study entry and intend to use until the end of subject participation; 5. Individual is pregnant or breast feeding female; 6. Individual and/or individual’ parent/guardians who are not able to comprehend or follow all required study procedures for the whole period of the study; 7. Individual has received prior Meningococcal ACWY vaccination that conflicts with national recommendations or local practices for timing of primary or booster vaccination 8. Individual has received influenza vaccination or has had documented influenza disease in the last 6 months; 9. Known or suspected congenital or acquired immunodeficiency; or receipt immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or systemic corticosteroid therapy (prednisone or equivalent) at any dose for more than 2 consecutive weeks (14 days) within the past 3months. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids is also permitted; 10. Administration of immunoglobulin and/or any blood products within the 3 months preceding vaccination, or planned administration during the study; 11. Individual has participated in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. Concomitant participation in an observational study (not involving drugs, vaccines, or medical devices) is acceptable; 12. Medical conditions or treatments contraindicating intramuscular vaccination due to increased risk of bleeding. These may include known bleeding disorders (such as thrombocytopenia), or treatment with anticoagulants (such as warfarin) in the 3 weeks preceding vaccination. However, antiplatelet agents such as low-dose aspirin, ticlopidine (Ticlid) and clopidogrel (Plavix) are permitted; 13. Evidence, or history (within the previous 12 months) of drug or alcohol abuse; 14. Study personnel or immediate family members (brother, sister, child, parent), the spouse of study personnel or individuals who are financially or emotionally dependent on study staff 15. Participation in this trial in a prior season, if applicable. 16. Any 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Primary Efficacy Objective(s): To demonstrate absolute vaccine efficacy of QIVc versus a non-influenza comparator determined by first occurrence RT-PCR or culture confirmed influenza, due to any influenza Type A and B strain in subjects =2 years to 14 days after the last vaccination and until the end of the influenza season. ;Timepoint(s) of evaluation of this end point: >14 days after the last vaccination and until the end of the influenza season. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: See above for specific timepoints per endpoint; Secondary end point(s): - Secondary Safety Endpoint(s) Safety will be assessed by calculating: * The percentage of subjects with solicited local and systemic adverse events for 7 days following vaccination at Day 1 (“previously vaccinated” subjects) or Day1 and Day 29, (“not previously vaccinated” subjects) in the QIVc group and the non-influenza comparator vaccine group. * The percentage of subjects with all unsolicited AEs will be assessed from Day 1 to Day 22 for “previously vaccinated” subjects or Day 1 to Day 50 for “not previously vaccinated” subjects in the QIVc group and in non-influenza comparator vaccine group. * Percentage of subjects with SAEs, AEs leading to withdrawal from the study and NOCDs reported during the subject’s entire participation in the study, i.e. from Day 1 to Day 181 (for “previously vaccinated” subjects) or to Day 209 (for “not previously vaccinated” subjects), or until the end of influenza season, whichever is longer, and all medications associated with these events. * Percentage of subjects with medically-attended adverse events within 30 days after of first occurrence RT-PCR confirmed ILI. - Secondary Efficacy Endpoint(s) * The efficacy endpoint for secondary objective 1 is the time from the last study vaccination to the onset of the first occurrence confirmed influenza by either RT-PCR confirmed or culture-confirmed, due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season. * The efficacy endpoint for secondary objective 2 is the time from the last study vaccination to the onset of the first-occurrence confirmed influenza by RT-PCR confi | — |
Countries
Australia, Estonia, Finland, Lithuania, Philippines, Poland, Spain, Thailand
Contacts
Public ContactMirjam van Huffelen
Seqirus Netherlands B.V.
Outcome results
None listed