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Phase IV Clinical Trial of an Influenza Split Vaccine Anflu

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556062
First Posted: November 9, 2007
Last Update Posted: November 14, 2007
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.
Information provided by:
Sinovac Biotech Co., Ltd
  Purpose
To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.

Condition Intervention Phase
Influenza Biological: seasonal split influenza vaccine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Clinical Trial for Three Consecutive Lots of Influenza Split Vaccine Anflu by Randomized, Double-Blind and Controlled Design

Resource links provided by NLM:


Further study details as provided by Sinovac Biotech Co., Ltd:

Primary Outcome Measures:
  • Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B [ Time Frame: 0, 21 days ]

Secondary Outcome Measures:
  • local and systematic adverse reactions after vaccination [ Time Frame: within 3 days after vaccination ]

Enrollment: 566
Study Start Date: September 2007
Study Completion Date: November 2007
Arms Assigned Interventions
Experimental: 1: Lot 1 Biological: seasonal split influenza vaccine
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
Experimental: 2: Lot 2 Biological: seasonal split influenza vaccine
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
Experimental: 3: Lot 3 Biological: seasonal split influenza vaccine
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
Active Comparator: 4: control vaccine Biological: seasonal split influenza vaccine
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults aged 18-60 years old
  • 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.
  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): NCT00556062


Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Zhilun Zhang Tianjin centers for Disease Control and Prevention
  More Information

ClinicalTrials.gov Identifier: NCT00556062     History of Changes
Other Study ID Numbers: PRO-INF-4005
First Submitted: November 8, 2007
First Posted: November 9, 2007
Last Update Posted: November 14, 2007
Last Verified: November 2007

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