The Immunogenicity and Safety of 2013-2014 Seasonal Trivalent Influenza Vaccine

NCT ID: NCT02269852

Last Updated: 2015-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-06-30

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.

Conditions

Influenza

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

trivalent seasonal influenza vaccine

Northern hemisphere 2013-2014 trivalent seasonal influenza vaccine

• 60 infants: two-dose regimen with a 28-day interval;
• 60 adults: single-dose regimen;
• 60 seniors: single-dose regimen;

Group Type: EXPERIMENTAL

trivalent seasonal influenza vaccine

Intervention Type: BIOLOGICAL

• Infants: 0.25 ml/ dose;
• Adults: 0.5 ml/ dose;
• Seniors: 0.5 ml/ dose;

Interventions

trivalent seasonal influenza vaccine

• Infants: 0.25 ml/ dose;
• Adults: 0.5 ml/ dose;
• Seniors: 0.5 ml/ dose;

Intervention Type: BIOLOGICAL

Other Intervention Names

Anflu®

Eligibility Criteria

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;

• 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

• 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:

• 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;

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yong-Gang Shen

Role: PRINCIPAL_INVESTIGATOR

Anhui Center for Diseases Control and Prevention

Locations

Guzhen Center for Diseases Control and Prevention

Bengbu, Anhui, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 26934750 (View on PubMed)

Other Identifiers

PRO-INF-4013

Identifier Type: -

Identifier Source: org_study_id