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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00325260
First received: May 11, 2006
Last updated: October 31, 2006
Last verified: October 2006
  Purpose

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 Intervention Phase
Healthy
Biological: Influvac; subunit influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

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

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

Estimated Enrollment: 900
Study Start Date: March 2006
  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00325260

Locations
China
Site 1
Nanjing, China
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00325260     History of Changes
Other Study ID Numbers: S201.3.121
Study First Received: May 11, 2006
Last Updated: October 31, 2006
Health Authority: China: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
influenza
non-inferiority
Influvac
Agrippal
healthy subjects

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 August 28, 2014