Skip to main content
OpenTrials
Completed

NCT Number: NCT00325260

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 1

Nanjing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Influvac; subunit influenza vaccine

Biological

Primary outcomes

  1. HI titers 4 weeks after vaccination (efficacy) and safety and tolerability

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2006
First posted
May 12, 2006
Registry last updated
Nov 1, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.