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Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine

NCT00999206 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3138

Last updated 2011-08-26

No results posted yet for this study

Summary

A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity

Conditions

Interventions

BIOLOGICAL

Influenza Vaccine

surface antigen, inactivated, prepared in cell cultures

BIOLOGICAL

Influenza Vaccine

surface antigen, inactivated, prepared in egg (influvac ®)

BIOLOGICAL

Influenza Vaccine

surface antigen, inactivated, prepared in cell cultures

BIOLOGICAL

Influenza Vaccine

surface antigen, inactivated, prepared in cell cultures

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Abbott Biologicals

    lead INDUSTRY

Principal Investigators

  • Hanka de Voogd, MD · Abbott Healthcare Products B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00999206 on ClinicalTrials.gov