Influenza
Conditions
Brief summary
A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years) to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's H1N1 influenza A Vaccine (PANFLU.1) with Trivalent Inactivated Influenza Vaccine (ANFLU).
Interventions
BIOLOGICALH1N1 influenza A Vaccine (PANFLU.1)
H1N1 influenza A Vaccine (PANFLU.1), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm)
BIOLOGICALTrivalent Inactivated Influenza Vaccine (ANFLU)
Trivalent Inactivated Influenza Vaccine (ANFLU), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (injected in the other arm)
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female aged between 18 and 60 2. Be able to show legal identity card for the sake of recruitment 3. Volunteers are able to understand and sign the informed consent
Exclusion criteria
1. Cases, cured cases and close contact of influenza A (H1N1) virus 2. History of H1N1 vaccine or seasonal influenza vaccine administration 3. Women of pregnancy, lactation or about to be pregnant in 60 days 4. Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc 5. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 6. Autoimmune disease or immunodeficiency 7. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids 8. Diabetes mellitus (type I or II), with the exception of gestational diabetes 9. History of thyroidectomy or thyroid disease that required medication within the past 12 months 10. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years 11. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws 12. Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study 13. Seizure disorder other than: * Febrile seizures under the age of two years old * Seizures secondary to alcohol withdrawal more than 3 years ago, or * A singular seizure not requiring treatment within the last 3 years 14. Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen 15. Guillain-Barre Syndrome 16. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis) 17. History of any blood products within 3 months before the dosing 18. Administration of any other investigational research agents within 30 days before the dosing 19. Administration of any live attenuated vaccine within 30 days before the dosing 20. Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing 21. Be receiving anti-TB prophylaxis or therapy currently 22. Axillary temperature \> 37.0 centigrade at the time of dosing 23. Psychiatric condition that precludes compliance with the protocol: * Past or present psychoses * Past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years * Disorder requiring lithium * Suicidal ideation occurring within five years prior to enrollment 24. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study the cell-mediated immunity of H1N1 vaccine with seasonal influenza vaccine | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in adults | 3 months |
| Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in adults | 3 months |
Countries
China
Outcome results
None listed