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The Immunogenicity and Safety of 2012-2013 Trivalent Seasonal Influenza Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01736709
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy older people aged > 60 years.

Condition or disease Intervention/treatment Phase
Influenza Biological: 2012-2013 trivalent seasonal influenza vaccine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Single-centered, Open-labeled, Phase 4 Study of 2012-2013 Trivalent Seasonal Influenza Vaccine
Study Start Date : November 2012
Primary Completion Date : April 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: trivalent seasonal influenza vaccine
2012-2013 trivalent seasonal influenza vaccine in 60 infants with two-dose regimen, 21 days interval trivalent seasonal influenza vaccine in 60 adults and 60 old people with single-dose regimen
Biological: 2012-2013 trivalent seasonal influenza vaccine
trivalent seasonal influenza vaccine with 0.25 ml ⁄ vial, for infants trivalent seasonal influenza vaccine with 0.5 ml ⁄ vial, for adults and old people


Outcome Measures

Primary Outcome Measures :
  1. Hemagglutination inhibition (HI) antibody titer of 2012-2013 trivalent seasonal influenza vaccine [ Time Frame: 21 days after vaccination ]
    to evaluate the immunogenicity of the vaccine in adults and old people.


Secondary Outcome Measures :
  1. Frequency of systemic and local adverse reactions after vaccination [ Time Frame: 0-21 days after vaccination ]
    to evaluate the safety of the vaccine in healthy infants, adults, and old people


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

For adults and old people:

Inclusion Criteria:

  • Healthy adults aged 18-60 years old, and healthy old people aged >60 years
  • Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
  • Not participate in any other clinical trials during the study
  • Not receive any immunosuppressive agents during and one month prior to the study
  • Be able to understand and sign the informed consent.

Exclusion Criteria:

  • Woman: Who breast-feeding or planning to become pregnant during the study
  • Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
  • Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  • Autoimmune disease or immunodeficiency
  • Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
  • Guillain-Barre Syndrome
  • Women subjects with positive urinary pregnancy test
  • Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
  • Axillary temperature >37.0 centigrade at the time of dosing
  • Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.

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(s) or legal guardian(s) are able to understand and sign the informed consent

Exclusion Criteria:

  • Administration of 2012-2013 seasonal vaccine
  • Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
  • Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  • Symptoms of acute infection within a week
  • Autoimmune disease or immunodeficiency
  • Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
  • Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
  • Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with Intramuscular injections or blood draws
  • History or family history of convulsions, epilepsy, brain disease and psychiatric
  • Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
  • Guillain-Barre Syndrome
  • History of any blood products within 3 months
  • Administration of any other investigational research agents within 30 days
  • Administration of any live attenuated vaccine within 30 days
  • Administration of subunit or inactivated vaccines within 14 days
  • Be receiving anti-Tuberculosis prophylaxis or therapy currently
  • Axillary temperature > 37.0 centigrade at the time of dosing
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736709


Locations
China, Henan
Henan Center for Diseases Control and Prevention
Zhengzhou, Henan, China
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Wan-Shen Guo, BS Henan Center for Diseases Control and Prevention
More Information

Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT01736709     History of Changes
Other Study ID Numbers: PRO-INF-4012
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: November 2012

Keywords provided by Sinovac Biotech Co., Ltd:
2012-2013 trivalent seasonal influenza vaccine
immunogenicity,
safety

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs