A Clinical Trial of Split-virion Influenza A/H1N1 Vaccines

NCT01004653 | Completed Phase 4

• 1 other identifier: PRO-PanFlu-4001-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A single center, Open-Label phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years to evaluate the immunogenicity and safety of Sinovac's 15μg H1N1 influenza A Vaccine (Split virion), Inactivated.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Evaluate immunogenicity of split-virion influenza A （H1N1）vaccine in elders

  Sep. 2009- Oct. 2009

Secondary Outcomes (1)

• Evaluate Safety of split-virion influenza A （H1N1）vaccine in elders

  Sep. 2009- Oct. 2009

Study Arms (1)

H1N1 influenza A Vaccine (Split virion), Inactivated

EXPERIMENTAL

15 μg H1N1 influenza A Vaccine (Split virion), Inactivated

Biological: H1N1 influenza A Vaccine (Split virion), Inactivated

Interventions

H1N1 influenza A Vaccine (Split virion), Inactivated BIOLOGICAL

100 elders were assigned to receive one dose of 15μg H1N1 influenza A Vaccine (Split virion), Inactivated

H1N1 influenza A Vaccine (Split virion), Inactivated

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cases, cured cases and close contact of influenza A (H1N1) virus
• 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

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Beijing Centers for Diseases Control and Prevention

Beijing, 100013, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

CN (1)