Influenza
Conditions
Keywords
seasonal trivalent inactivated influenza vaccine, immunogenicity, safety, cross-reactivity, Northern hemisphere 2013-2014 formulation
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged \> 60 years.
Interventions
BIOLOGICALtrivalent seasonal influenza vaccine
* Infants: 0.25 ml/ dose; * Adults: 0.5 ml/ dose; * Seniors: 0.5 ml/ dose;
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
For adults and seniors: Inclusion Criteria: * Healthy adults aged 18-60 years old, and healthy seniors aged \> 60 years old; * Without vaccination history of seasonal split influenza vaccine in the recent 3 years * No traveling plan during the study period of this trial; * Be able to understand and sign the informed consent;
Exclusion criteria
* Allergic to egg products or any ingredient of the study vaccine; * Fever, influenza or acute illness on the vaccination day; * Acute stage of chronic illness; * Malignant tumor; * Immunodeficiency, includes HIV infection; * Guillain-Barre syndrome; * Administration of live attenuated vaccine within the previous 14 days; * Administration of subunit or inactivated vaccine within the previous 7 days; * Planned to participate in any other clinical trial of drug or vaccine during this study; * Received immunesuppressive treatment within the previous month, or planned for such treatment during this study; * Pregnant, or planning pregnancy; * Axillary temperature \> 37.0℃; * Any other factors that, in the judgment of the investigator, is unsuitable for this study; For infants: Inclusion Criteria: * Healthy male or female aged between 6 and 35 months; * Full-term birth, birth weight 2,500 grams or more; * Provided birth certification or vaccination card * Parent or legal guardian is able to understand and sign the informed consent;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors | 21 days after vaccination | To evaluate the immune responses to each antigen of the 2013-2014 seasonal TIV in adults and seniors by detection of hemagglutination inhibition (HI) antibody titer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidences of adverse events (AEs) in infants, adults and seniors | Day 0 - day 35 | After each injection, a 30-minute safety observation was conducted immediately, and the body temperature, occurrence of solicited local and general AEs within 72 hours were collected. Unsolicited AEs of adults and seniors were collected until day 21, and those of infants were collected until day 35. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination). |
| The cross-reactivity of 2013-2014 seasonal TIV in adults and seniors against influenza B Victoria lineage virus and the avian influenza A(H7N9) virus | 21 days after vaccination | To evaluate the cross-reactivity of 2013-2014 seasonal TIV in adults and seniors against influenza B Victoria lineage virus (not in the vaccine formulation) and the avian influenza A(H7N9) virus by detection of HI antibody titer |
Countries
China
Outcome results
None listed