Prophylaxis of influenza virus infection MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Seqirus UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals of 6 through 47 months of age on the day of informed consent. Individuals whose parent(s)/LAR have voluntarily given written informed 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. Individuals in generally good health as per the Investigator’s medical judgement. Are the trial subjects under 18? yes Number of subjects for this age range: 3830 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Acute (severe) febrile illness (see Section 4.3 Criteria for Delay of Vaccination). Enrollment could be considered if the fever is absent for 72 hours. 2. History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study. 3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination. 4. A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis. 5. Abnormal function of the immune system resulting from clinical conditions, which include: a. Known or suspected congenital or acquired immunodeficiency. b. Systemic administration of corticosteroids (PO/IV/IM) at any dose for more than 14 days, within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids is also permitted. c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. 6. Received immunoglobulins or any blood products within 180 days prior to informed consent. 7. Received an investigational or non-registered medicinal product within 30 days prior to informed consent, or intend to participate in another clinical trial during the study. 8. Participated in this trial in a prior season or is discontinued after randomization in the current season. 9. Study personnel, family and household members of study personnel should not participate. 10. 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. 11. Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent. 12. Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism. 13. Received any other vaccines than influenza vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to study vaccination or who are planning to receive any vaccine within 28 days after study vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: EFFICACY: To demonstrate the absolute vaccine efficacy of QIVc versus a non-influenza vaccine to prevent at least one of the following: - RT-PCR confirmed illness caused by any influenza Type A and/or Type B virus, regardless of antigenic match. - Culture confirmed illness caused by influenza virus strains antigenically matched to the influenza strains selected for the seasonal influenza vaccine.;Secondary Objective: EFFICACY: Efficacy objectives evaluating QIVc compared to a non-influenza vaccine or placebo: - Prevention of culture confirmed illness caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine. - Prevention of culture confirmed illness caused by any Type A and/or Type B virus. - Prevention of RT-PCR confirmed moderate-to-severe influenza caused by any influenza Type A and/or Type B virus. IMMUNOGENICITY: To evaluate the immune response after vaccination with QIVc, 4 weeks after last vaccination in a sub-set of subjects 6 months through 47 months of age in each study vaccine group. SAFETY: To evaluate the safety and tolerability of QIVc among subjects 6 months through 47 months of age in the QIVc group and comparator group.;Primary end point(s): 1. Efficacy Endpoint: First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine in association with protocol-defined ILI symptoms 2.Efficacy Endpoint: First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the influenza strains selected for the seasonal influenza vaccine in association with protocol-defined ILI symptoms;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 |
|---|---|
| Secondary end point(s): 1. Efficacy Endpoint: first occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine 2. Efficacy Endpoint: first occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine in association with protocol-defined ILI symptoms. 3.Efficacy Endpoint: first occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine 4. Immunogenicity Endpoint: Pre and post-vaccination geometric mean titers (GMTs) 5.Immunogenicity Endpoint: 2. Seroconversion rates (SCR) 6. Immunogenicity Endpoint: Geometric mean ratio (GMR) 7. Safety Endpoint: Percentage of subjects with solicited local and systemic adverse events 8. Safety Endpoint: Percentage of subjects with unsolicited adverse events 9. Safety Endpoint: Percentage of subjects with SAEs, NOCDs, AE leading to withdrawal from the study or vaccination 10. Safety Endpoint: Percentage of subjects with medically attended adverse events after ILI onset;Timepoint(s) of evaluation of this end point: Efficacy endpoints 1, 2 and 3: > 14 days after the last vaccination and until the end of the influenza season Immunogenicity endpoint 4, 5 and 6: Day 1 and 28 days after last vaccination Safety endpoint 7: 1 to 7 days after each vaccination Safety endpoint 8: Day 1 to 28 days after last vaccination Safety endpoint 9: Day 1 to LSLV Safety endpoint 10: day of ILI onset to 30 days after ILI onset | — |
Countries
Bangladesh, Bulgaria, Czechia, Czech Republic, Dominican Republic, Estonia, Honduras, Latvia, Malaysia, New Zealand, Pakistan, Philippines, Poland, Romania, South Africa, Thailand, Ukraine
Contacts
Public ContactClinical Trial Disclosures
Seqirus UK Limited
Outcome results
None listed