Clinical trial NCT01047202: Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants
Official title: A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2010-01-12
Enrollment: 310
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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

Primary outcomes:
measure: Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants
timeFrame: 3 months
Secondary outcomes:
measure: Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants
timeFrame: 3 months
Other outcomes:
Locations:
city: Guilin
country: China
facility: GuangXi Center for Diseases Control and Prevention
state: Guangxi
Study officials:
References:
citation: Li YP, Li W, Liang XF, Liu Y, Huang XC, Li CG, Li RC, Wang JZ, Wang HQ, Yin WD. Immunogenicity and safety of a 2009 pandemic influenza A (H1N1) monovalent vaccine in Chinese infants aged 6-35 months: a randomized, double-blind, controlled phase I clinical trial. Influenza Other Respir Viruses. 2013 Nov;7(6):1297-307. doi: 10.1111/irv.12028. Epub 2012 Nov 8.