Influenza
Conditions
Brief summary
A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).
Interventions
BIOLOGICALPandemic influenza A/H1N1 vaccine
Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
BIOLOGICALSeasonal trivalent vaccine
Trivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female aged between 6 and 35 months 2. Full-term birth, birth weight 2,500 grams or more 3. provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent
Exclusion criteria
1. Cases, cured cases and close contact of influenza A (H1N1) virus 2. 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 3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 4. Symptoms of acute infection within a week 5. Autoimmune disease or immunodeficiency 6. Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders) 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. 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 9. History or family history of convulsions, epilepsy, brain disease and psychiatric 10. Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen 11. Guillain-Barre Syndrome 12. Administration of 2009-2010 seasonal vaccine 13. History of any blood products within 3 months 14. Administration of any other investigational research agents within 30 days 15. Administration of any live attenuated vaccine within 30 days 16. Administration of subunit or inactivated vaccines within 14 days 17. Be receiving anti-TB prophylaxis or therapy currently 18. Axillary temperature \> 37.0 centigrade at the time of dosing 19. 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 |
|---|---|
| Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants | 3 months |
Countries
China
Outcome results
None listed