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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

trivalent seasonal influenza vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring seasonal trivalent inactivated influenza vaccine, immunogenicity, safety, cross-reactivity, Northern hemisphere 2013-2014 formulation

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

Guzhen Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

trivalent seasonal influenza vaccine

Arm Description

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;

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

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

Full Information

NCT ID

NCT02269852

First Posted

October 8, 2014

Last Updated

September 18, 2015

Sponsor

Sinovac Biotech Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02269852

Brief Title

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

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinovac Biotech Co., Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

seasonal trivalent inactivated influenza vaccine, immunogenicity, safety, cross-reactivity, Northern hemisphere 2013-2014 formulation

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

182 (Actual)

8. Arms, Groups, and Interventions

Arm Title

trivalent seasonal influenza vaccine

Arm Type

Experimental

Arm Description

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;

Intervention Type

Biological

Intervention Name(s)

trivalent seasonal influenza vaccine

Other Intervention Name(s)

Anflu®

Intervention Description

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

Primary Outcome Measure Information:

Title

The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors

Description

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

Time Frame

21 days after vaccination

Secondary Outcome Measure Information:

Title

The incidences of adverse events (AEs) in infants, adults and seniors

Description

Time Frame

Day 0 - day 35

Title

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

Description

Time Frame

21 days after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong-Gang Shen

Organizational Affiliation

Anhui Center for Diseases Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guzhen Center for Diseases Control and Prevention

City

Bengbu

State/Province

Anhui

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

26934750

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.

Results Reference

derived

Learn more about this trial

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

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