no medical condition, healthy volunteers will be recruited into the clinical trial for annual approval of influenza vaccine with the new strain composition according WHO and EMEA recommendation and CPMP criteria (CPMP/BWP/214/96). MedDRA version: 12.1 Level: LLT Classification code 10022000 Term:
Conditions
Interventions
Trade Name: Begrivac
Product Name: Begrivac
Product Code: V44
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza A /California/7/2009 (H1N1)-like virus
Concentration unit:
Sponsors
Novartis Vaccines and Diagnostics GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment into this study are male and female adults who are 1. = 18 years of age, mentally competent, willing and able to give informed consent prior to study entry 2. able to comply with all study requirements 3. in good health as determined by: - medical history - physical examination - clinical judgment of the investigator Informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study; 2. Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to: a. Cancer, except for localized skin cancer; b. Advanced congestive heart failure; c. Chronic obstructive pulmonary disease (COPD); d. Autoimmune disease (including rheumatoid arthritis); e. Acute or progressive hepatic disease; f. Acute or progressive renal disease; g. Severe neurological or psychiatric disorder; h. Severe asthma; 3. Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, Polymyxin B; 4. Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: a. receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; b. receipt of immunostimulants; c. receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; d. suspected or known HIV infection or HIV-related disease; 5. Individuals with known or suspected history of drug or alcohol abuse; 6. Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject; 7. Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing age do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide),,intrauterine device (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry; 8. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study; 9. Individuals that within the past 12 months have received more than one injection of influenza vaccine; 10. Individuals that within the past 6 months have: a. had laboratory confirmed seasonal or pandemic influenza disease; b. received seasonal or pandemic influenza vaccine; 11. Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days 12. Individuals that have experienced fever (i.e., axillary temperature = 38°C) within the last 3 days of intended study vaccination 13. Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. 14. Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines 15. Individuals who have received blood, blood products and/or plasma derivatives or any parentera
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objectives To evaluate the antibody response to each influenza vaccine antigen, as measured by hemagglutination inhibition (HI) test on Day 1 and on Day 22, i.e., 21 days after vaccination in non-elderly adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96). Antibodies may be additionally quantified using the Single Radial Hemolysis (SRH) test for confirmation purposes. (Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. CPMP/BWP/214/96: 12 March 1997).” Safety Objectives To evaluate safety of a single IM (intramuscular) dose of the split influenza vaccine Begrivac® in non-elderly adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96). ;Secondary Objective: na;Primary end point(s): Immunogenicity Endpoints The following serological assessments will be considered for each strain in non-elderly adult subjects, aged between 18 and 60, and at least one of the assessments should meet the indicated requirements: - The proportion of subjects achieving seroconversion or significant increase in anti-HA antibody titer or SRH area should be > 40% - Mean geometric increase > 2.5 - The proportion of subjects achieving an HI titer = 40 or SRH area = 25 mm2 should be > 70% The following serological assessments will be considered for each strain in elderly subjects, aged over 60, and at least one of the assessments should meet the indicated requirements: - Proporion of seroconversions or significant increase in anti-HA antibody titer > 30% - Mean geometric increase > 2.0 - The proportion of subjects achieving an HI titer = 40 or SRH area = 25 mm2 should be > 60% Safety Endpoints Safety will be assessed in accordance with available safety data on influenza vaccines. | — |
Countries
Germany
Outcome results
None listed