Clinical trial NCT02269852: The Immunogenicity and Safety of 2013-2014 Seasonal Trivalent Influenza Vaccine
Official title: A Single-centered, Open-labeled, Phase 4 Study of a Northern Hemisphere 2013-2014 Seasonal Trivalent Influenza Inactivated Vaccine, Anflu®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: seasonal trivalent inactivated influenza vaccine
immunogenicity
safety
cross-reactivity
Northern hemisphere 2013-2014 formulation
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 182
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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;

Exclusion Criteria:

* Received seasonal influenza vaccine after June 30, 2012;
* Acute infection within the previous week;
* Allergy history, or allergic to any ingredient of the study vaccine, such as egg;
* History of serious adverse reaction (SAR) to vaccine;
* Autoimmune disease or immune deficiency, or administration of immunosuppressive therapy, cell toxic therapy, or inhaled corticosteroid within the previous 6 months;
* Congenital malformations, developmental disorder or serious chronic disease;
* Unstable condition of asthma and administration of corticosteroid in the most recent two years;
* Coagulation abnormalities or disorders;
* History/ family history of infantile convulsion, epilepsy, cerebropathy, or mental disease;
* Without spleen;
* Severe neurological diseases, such as Guillain-Barre syndrome;
* Administration of blood products or investigational drug within the previous month;
* Administration of live attenuated vaccine within the previous 14 days;
* Administration of subunit or inactivated vaccine within the previous 7 days;
* Received treatment for allergy within the previous 14 days;
* on-going anti-tuberculosis therapy;
* Axillary temperature \> 37.0℃ immediately before vaccination;
* any other factors that, in the judgment of the investigator, is unsuitable for this study;

Primary outcomes:
measure: The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors
timeFrame: 21 days after vaccination
Secondary outcomes:
measure: The incidences of adverse events (AEs) in infants, adults and seniors
timeFrame: Day 0 - day 35
measure: 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
timeFrame: 21 days after vaccination
Other outcomes:
Locations:
city: Bengbu
country: China
facility: Guzhen Center for Diseases Control and Prevention
state: Anhui
Study officials:
affiliation: Anhui Center for Diseases Control and Prevention
name: Yong-Gang Shen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shen Y, Hu Y, Meng F, Du W, Li W, Song Y, Ji X, Huo L, Fu Z, Yin W. Safety, immunogenicity and cross-reactivity of a Northern hemisphere 2013-2014 seasonal trivalent inactivated split influenza virus vaccine, Anflu(R). Hum Vaccin Immunother. 2016 May 3;12(5):1229-34. doi: 10.1080/21645515.2015.1123357. Epub 2016 Mar 2.