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

September 18, 2015 updated by: Sinovac Biotech Co., Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors
Time Frame: 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
21 days after vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidences of adverse events (AEs) in infants, adults and seniors
Time Frame: 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).
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
Time Frame: 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
21 days after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac Biotech Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yong-Gang Shen, Anhui Center for Diseases Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-INF-4013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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