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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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influenza non-inferiority Influvac Agrippal healthy subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Influvac; subunit influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 1

Nanjing, , China

Site Status

Countries

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China

Other Identifiers

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S201.3.121

Identifier Type: -

Identifier Source: org_study_id