Phase IV Clinical Trial of an Influenza Split Vaccine Anflu

This study has been completed.
Sponsor:
Information provided by:
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT00556062
First received: November 8, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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: Double Blind (Subject, 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556062

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

No publications provided

ClinicalTrials.gov Identifier: NCT00556062     History of Changes
Other Study ID Numbers: PRO-INF-4005
Study First Received: November 8, 2007
Last Updated: November 8, 2007
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014