Prophylaxis of Influenza MedDRA version: 20.0 Level: HLT Classification code 10022005 Term: Influenza viral infections System Organ Class: 100000004862
Conditions
Interventions
Product Name: Quadrivalent Influenza Vaccine
Product Code: QIV
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: influenza vaccine (surface antigen, inactivated
Sponsors
Abbott Biologicals B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male and female children and adolescents 3 to 17 years of age at the time of enrolment in stable health determined from medical history, physical examination and clinical judgment of the Investigator*. Subjects may have underlying illnesses as long as their symptoms/signs are controlled. •The subject’s parent(s) or LAR(s) sign and date a written, informed consent form (ICF). An assent will also be obtained according to age appropriate country-specific regulations. •Subject and parent(s) or LAR(s) are able and willing to attend all scheduled visits and to comply with all trial procedures. *In Germany, due to local requirements, the investigator must adhere to the current recommendation of the German Standing Committee on Vaccination (STIKO) for the clinical trial conduct with children. Accordingly, German subjects may only be enrolled if an influenza vaccination is medically indicated (due to an increased health risk from an underlying disease such as chronic diseases of the respiratory tract [including asthma and COPD], chronic cardiovascular, liver and kidney diseases, chronic neurological diseases, diabetes and other metabolic diseases). This restriction implies that inclusion criterion nr. 5 is not violated (i.e. the requirements for stable underlying conditions are met) and that none of the exclusion criteria are met. Are the trial subjects under 18? yes Number of subjects for this age range: 1200 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.Child in care (as defined in the protocol) 2.History of allergy to egg, chicken proteins, or history of any reaction or hypersensitivity to a previous dose of influenza vaccine components. 3.History of serious adverse reaction to any influenza vaccine. 4.History of Guillain-Barré syndrome. 5.History of seizures (subject who had a single uncomplicated febrile convulsion in the past could be included) or progressive neurological disease. 6.Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). 7.Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) or laboratory-confirmed influenza infection in the 6 months preceding the first study vaccination. 8.Receipt of any vaccine (including routine childhood vaccines) within the preceding 30 days or planned vaccination during the study within 30 days after any study vaccine administration. 9.Having fever and/or acute disease or infection on the day of first study vaccination (enrolment can be deferred for up to 2 weeks provided subject remains otherwise eligible). 10.Any known immunocompromising condition or immunosuppressive therapy within 6 months preceding enrolment. 11.Chronic systemic administration (defined as more than 14 days) of immunosuppressant or immune-modifying medication (such as corticosteroids and monoclonal antibodies) during 3 months prior to the first study vaccination or planned use thereof during the study. Topical use of corticosteroids (e.g., cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed. 12. Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine including (but not limited to) bleeding disorder, acute or progressive clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and/or physical examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate in a population of children and adolescents 3 to 17 years of age the non-inferiority of quadrivalent influenza vaccine (QIV) with respect to post-vaccination geometric mean Hemagglutination Inhibition (HI) antibody titers against the shared strains compared with the trivalent influenza vaccines (TIV) with either the B-strain of the Victoria (TIV(Vic)) or the B-strain of the Yamagata lineage (TIV(Yam)).;Secondary Objective: 1.To demonstrate the superiority of QIV to TIV(Vic) and TIV(Yam)with respect to post-vaccination geometric mean HI antibody titers against the alternate-lineage B strain in a population of children and adolescents 3 to 17 years of age. 2.To describe the immunogenicity of each of the strains in QIV with respect to HI, Virus Neutralization (VN) and Neuraminidase Inhibition (NI) antibody titers in the study population overall and by subject age, preexisting antibody status and baseline health status. 3.To describe Cell-Mediated Immunity (CMI) values for a subset of subjects. Safety Objective: To compare the reactogenicity and safety of QIV with that of TIV in a population of children and adolescents 3 to 17 years of age. ;Primary end point(s): The primary endpoint concerns the geometric mean HI antibody titers against the 4 vaccine strains ;Timepoint(s) of evaluation of this end point: 28 days after study vaccination (Day 29, primed subjects) or 28 days after the second study vaccination (Day 57, unprimed subjects). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints concern: 1)Change from baseline geometric mean HI antibody titers against the 4 vaccine strains. 2)Post-vaccination geometric mean VN and NI antibody titers and change from baseline against the 4 vaccine strains for a randomized subset of subjects. 3)Seroconversion rates and geometric mean fold increases for HI, VN and NI for the 4 vaccine strains for a randomized subset of subjects. 4)Post-vaccination CMI values for a subset of subjects and change from baseline. Safety points: 1)All unsolicited (spontaneously reported) AEs 2)SAEs, AESIs and NCIs 3) Solicited injection site reactions and systemic reactions ;Timepoint(s) of evaluation of this end point: 1)2)3)4: Day 29 for primed subjects Day 57 for unprimed subjects For Safety points: 1) From ICF signature to Day 29 (primed subjects) or Day 57 (unprimed subjects) 2) from ICF signature to final follow-up telephone call approximately 6 months later (Day 183) 3) within 7 days following each study vaccination. | — |
Countries
Estonia, Finland, Germany, Hungary, Lithuania, Poland
Contacts
Public ContactGlobal Clinical Director
Abbott Biologicals B.V.
Outcome results
None listed