Non-Inferiority Study Comparing the Subunit Vaccines Influvac and Agrippal in China

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. Identifier: NCT00325260
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : November 1, 2006
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is already on the market in China. The main objective of the study is to show that both vaccines are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac will be assessed in the Chinese population.

Condition or disease Intervention/treatment Phase
Healthy Biological: Influvac; subunit influenza vaccine Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Endpoint-Blind, Parallel Group Study to Demonstrate the Non-Inferiority of the Subunit Influenza Vaccine Influvac® to the Subunit Influenza Vaccine Agrippal® in Healthy Children, Adults and Elderly in China.
Study Start Date : March 2006

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. HI titers 4 weeks after vaccination (efficacy) and safety and tolerability

Secondary Outcome Measures :
  1. HI derived parameters: seroprotection, seroconversion and mean fold increase 4 weeks after vaccination

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • signed and dated informed consent
  • being healthy
  • mental health enough to understand the study, the informed consent form and the questionnaire

Exclusion Criteria:

  • known to be allergic to constituents of the vaccine
  • having an autoimmune disorder, taking immunomodulating drugs or having immune disfunction secondary to HIV
  • having had a documented serious adverse reaction to previous influenza vaccination
  • having had documented influenza infection or vaccination in the six months prior to the start of the study
  • having received any other vaccines, immunoglobulins or investigational drugs in the month prior to the start of the study

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 identifier (NCT number): NCT00325260

Site 1
Nanjing, China
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals Identifier: NCT00325260     History of Changes
Other Study ID Numbers: S201.3.121
First Posted: May 12, 2006    Key Record Dates
Last Update Posted: November 1, 2006
Last Verified: October 2006

Keywords provided by Solvay Pharmaceuticals:
healthy subjects

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs