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OpenTrials
Completed

NCT Number: NCT01008137

Sinovac, H1N1 Vaccine + Trivalent Inactivated Influenza Vaccine, Adults

A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years) to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's H1N1 influenza A Vaccine (PANFLU.1) with Trivalent Inactivated Influenza Vaccine (ANFLU).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Centers for Diseases Control and Prevention

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female aged between 18 and 60
  • Be able to show legal identity card for the sake of recruitment
  • Volunteers are able to understand and sign the informed consent

Exclusion criteria

  • Cases, cured cases and close contact of influenza A (H1N1) virus
  • History of H1N1 vaccine or seasonal influenza vaccine administration
  • Women of pregnancy, lactation or about to be pregnant in 60 days
  • 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
  • Autoimmune disease or immunodeficiency
  • 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
  • Diabetes mellitus (type I or II), with the exception of gestational diabetes
  • History of thyroidectomy or thyroid disease that required medication within the past 12 months
  • Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
  • Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
  • Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
  • Seizure disorder other than:
  • Febrile seizures under the age of two years old
  • Seizures secondary to alcohol withdrawal more than 3 years ago, or
  • A singular seizure not requiring treatment within the last 3 years
  • Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
  • Guillain-Barre Syndrome
  • 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)
  • History of any blood products within 3 months before the dosing
  • Administration of any other investigational research agents within 30 days before the dosing
  • Administration of any live attenuated vaccine within 30 days before the dosing
  • Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
  • Be receiving anti-TB prophylaxis or therapy currently
  • 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
  • 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

Treatment and study plan

H1N1 influenza A Vaccine (PANFLU.1)

Biological

H1N1 influenza A Vaccine (PANFLU.1), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm)

Trivalent Inactivated Influenza Vaccine (ANFLU)

Biological

Trivalent Inactivated Influenza Vaccine (ANFLU), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (injected in the other arm)

Primary outcomes

  1. Study the cell-mediated immunity of H1N1 vaccine with seasonal influenza vaccine

    Time frame: 6 months

Secondary outcomes

  1. Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in adults

    Time frame: 3 months

  2. Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in adults

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Sinovac Biotech Co., Ltd

Industry

Registry information

Official study title

Cell-mediated Immunity Study of H1N1 Influenza A Vaccine With Trivalent Inactivated Influenza Vaccine in Healthy Adults

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Nov 5, 2009
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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