Influenza
Conditions
Interventions
1:Yuganning: Vaxigrip 1:1 Inject 1 dose at day1
2:Vaxigrip 600( 3 batch 1:1:1) Vaxigrip 100 Inject 1 dose at day 1
3:Yuganning: Vaxigrip 1:1 Inject 1 dose at day1
Sponsors
Zhejiang Tianyuan Bio-Pharmaceutical Co. Ltd. (a Novartis Company)
Eligibility
Sex/Gender
All
Age
3 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Chinese Males and females volunteers of 3 years of age or older, at the time of enrollment; 2. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator; 3. Mentally competent individuals, willing and able to give written informed consent prior to study entry (or where applicable, informed consent provided by individuals' parents/legal guardians); 4. Subjects willing and able to comply with all the study requirements; 5. Female subjects must be either of non-childbearing potential, i.e., surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophrectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal; or, if of childbearing potential, must be abstinent or use acceptable birth control measures for the whole 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 subjects study entry.
Exclusion criteria
Exclusion criteria: 1. Individuals, within the past 6 months: -have suffered from any seasonal or pandemic influenza disease; -or have received any seasonal or pandemic influenza vaccine. 2. Individuals who have received, within 4 weeks prior to enrollment date of study or who are planning to receive within 4 weeks from the study vaccination, any other vaccine (other than the seasonal or pandemic influenza vaccine); 3. Individuals that have experienced fever (defined as axillary temperature ?37.5 degree C or 99.5 degree F) within the last 3 days of intended study vaccination; 4. Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy, within the last 7 days; 5. 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 eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate); 6. Individuals with any known serious chronic or acute disease, as judged by the investigator), including but not limited to: - medically significant cancer (except for benign or localized skin cancer, cancer in remission for >=10 years or localized prostate cancer that has been clinically stable for more than 2 years without treatment); - medically significant advanced congestive heart failure (ie. nyha class iii and iv); - chronic obstructive pulmonary disease (copd); - autoimmune disease (including rheumatoid arthritis, except for hashimoto's thyroiditis that has been clinically stable for >=5 years); - diabetes mellitus type i and poorly controlled diabetes mellitus type ii; - history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., downs syndrome); - severe neurological disorder (es. Guillain–Barré syndrome) - severe uncontrolled allergies including asthma (stable seasonal allergies or controlled asthma under inhalative treatment can be included): - acute or progressive hepatic, cardiac (including advanced arteriosclerotic) and renal disease; 7. 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: - receipted immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; - receipted immunostimulants; - known or suspected HIV infection or HIV-related disease. 8. Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigators opinion would interfere with the safety of the subject; 9. Individuals who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks or plan to receive during the full length of the study period. 10. Individuals with known or suspected history of drug or alcohol abuse; 11. Females who are pregnant or nursing (breastfeeding) mothers; 12. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to comprehend and participate in the study; 13. Individuals who have used any other investigational product within
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The immunogenicity criteria for success, as determined by HI against the A/H1N1-like strain, A/H3N2-like strain and B-like strain, related to the EMEA/CPMP/BWP/214/96-guideline are:;Safety will be assessed in accordance with available safety data on influenza vaccines.; | — |
Primary
| Measure | Time frame |
|---|---|
| The measures of immunogenicity, as determined by the HI assay, against each of the three strains (A/H1N1; A/H3N2 and B);The ratios of post-vaccination (Day 22) GMTs between the three lots are equivalent (i.e., Lot A to B; Lot B to C, Lot A to C) with the lower and upper limits of the two sided 95% CI within the range of 0.5 to 2 (between -0.301 and 0.301 on log10 scale) for each vaccine strain.; | — |
Countries
China
Contacts
Public ContactYanjun Kong
Outcome results
None listed