NCT00325260

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
Last Updated

November 1, 2006

Status Verified

October 1, 2006

First QC Date

May 11, 2006

Last Update Submit

October 31, 2006

Conditions

Healthy

Keywords

influenzanon-inferiorityInfluvacAgrippalhealthy subjects

Outcome Measures

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

Interventions

Influvac; subunit influenza vaccineBIOLOGICAL

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • signed and dated informed consent
  • being healthy
  • mental health enough to understand the study, the informed consent form and the questionnaire

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 1

Nanjing, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

influvac

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 12, 2006

Study Start

March 1, 2006

Last Updated

November 1, 2006

Record last verified: 2006-10

Locations

CN(1)