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

Solvay

Status and phase

Completed

Phase 3

Conditions

Healthy

Treatments

Biological: Influvac; subunit influenza vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00325260

S201.3.121

Details and patient eligibility

About

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.

Sex

All

Ages

3+ years old

Volunteers

Accepts Healthy Volunteers

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