Prophylaxis of Influenza MedDRA version: 18.1 Level: HLT Classification code 10022005 Term: Influenza viral infections System Organ Class: 100000004862 MedDRA version: 18.1 Level: PT Classification code 10062297 Term: Immunology test System Organ Class: 10022891 - Investigations MedDRA version: 18.1 Level: PT Classification code 10065109 Term: Reactogenicity event System Organ Class: 10018065 - General disorders and administration site conditions
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, inactivate
Sponsors
Abbott Biologicals B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. Men and women aged = 18 years of age at the day of study vaccination. 3. Being in good health as judged by medical history, physical examination and clinical judgment of the Investigator (subjects may have underlying chronic illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as their symptoms/signs are controlled. If on regular prescribed medication for a condition, the medication dose must have been stable for at least three months preceding study vaccination). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 840
Exclusion criteria
Exclusion criteria: 1. History of allergy to egg, chicken proteins, or other vaccine components. 2. History of serious adverse reaction to any influenza vaccine. 3. History of Guillain-Barré syndrome. 4. Confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment. 5. Receipt of any vaccine within the preceding 4 weeks prior to study vaccination or planned vaccination during the study between Visit 1 (Day 1) and Visit 2 (Day 22). 6. Having fever and/or presenting with an acute disease or infection on the day of study vaccination. Fever is defined as an oral temperature of = 38.0 ºC. 7. Any known immunocompromising condition or immunosuppressive therapy within 6 months preceding study vaccination. 8. Using or having used medication that influences the immune system (such as corticosteroids and monoclonal antibodies) during the four weeks prior to the study or planned use thereof during the study. Topical use of corticosteroids (i.e., cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed. 9. Receipt of blood or blood products within the 3 months preceding enrollment. 10. Participation in a placebo-controlled influenza vaccine clinical trial any time prior to entering this study if the treatment arm is not known. 11. 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 study vaccine including (but not limited to) bleeding disorder, known immunodeficiency, seizure disorder, acute, severe or progressive hepatic, renal, neurological or neuromuscular disease. 12. Being a solid organ or bone marrow/stem cell transplant recipient. 13. Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within 36 months before the day of study vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate in subjects = 18 years of age the non-inferiority of QIV with respect to post-vaccination geometric mean hemagglutinin 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: To demonstrate in subjects = 18 years of age the superiority of QIV to TIV(Vic) and TIV(Yam) with respect to post-vaccination geometric mean hemagglutinin inhibition (HI) antibody titers against the alternate-lineage B strain. To describe the immunogenicity with respect to HI and virus neutralization (VN) antibody titers using the derived serology parameters seroconversion and geometric mean fold increase for each of the strains in QIV and TIV, in adults (= 18 to = 60 years of age) and elderly (= 61 years of age). To describe the immunogenicity with respect to HI and VN antibody titers in study population subsets according to age and pre-existing antibody status for each of the strains in QIV and TIV. To describe cell-mediated immunity values for a subset of subjects. ;Primary end point(s): Non-inferiority will be inspected by calculating for each of the two A-strains and each of the two B-strains a two-sided 95% confidence interval for geometric mean ratios (GMRs) for the contrast TIV versus QIV, using an analysis of variance model for the log-transformed titers;Timepoint(s) of evaluation of this end point: Visit 2 (Day 22 -2/+4 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Safety;Timepoint(s) of evaluation of this end point: At each visit or phone contact | — |
Countries
Belgium, Germany, Hungary, Latvia, Lithuania
Contacts
Public ContactGlobal Clinical Director
Abbott Biologicals B.V.
Outcome results
None listed