Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants
Information source: Sinovac Biotech Co., Ltd
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: Pandemic influenza A/H1N1 vaccine (Biological); Pandemic influenza A/H1N1 vaccine (Biological); Seasonal trivalent vaccine (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Sinovac Biotech Co., Ltd
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).
Clinical Details
Official title: A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Primary outcome: Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants
Secondary outcome: Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants
Eligibility
Minimum age: 6 Months.
Maximum age: 35 Months.
Gender(s): Both.
Criteria:
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
Locations and Contacts
GuangXi Center for Diseases Control and Prevention, Guilin, Guangxi, China
Additional Information
Starting date: December 2009
Last updated: March 13, 2013
|
