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

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 III

MedlinePlus related topics:

Flu

ChemIDplus related topics:

Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

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

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

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

Keywords provided by Solvay Pharmaceuticals:

influenza

non-inferiority

Influvac

Agrippal

healthy subjects

Study placed in the following topic categories:

Influenza, Human

Healthy

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00325260