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

A Single-centered, Open-labeled, Phase 4 Study of a Northern Hemisphere 2013-2014 Seasonal Trivalent Influenza Inactivated Vaccine, Anflu®

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: trivalent seasonal influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Guzhen Center for Diseases Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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;	Biological: trivalent seasonal influenza vaccine; Infants: 0.25 ml/ dose;; Adults: 0.5 ml/ dose;; Seniors: 0.5 ml/ dose; Other Names: Anflu®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors	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	21 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidences of adverse events (AEs) in infants, adults and seniors	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).	Day 0 - day 35
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	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	21 days after vaccination

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd
• Investigators: Principal Investigator: Yong-Gang Shen, Anhui Center for Diseases Control and Prevention

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Estimate): September 21, 2015
• Last Update Submitted That Met QC Criteria: September 18, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: safety; immunogenicity; cross-reactivity; seasonal trivalent inactivated influenza vaccine; Northern hemisphere 2013-2014 formulation
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: PRO-INF-4013