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OpenTrials
Completed

NCT Number: NCT00999206

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 44652, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age).
  • Willing and able to give informed consent before any protocol procedures are performed.
  • Able to adhere to visit schedules and all protocol required study procedures.
  • Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).

Exclusion criteria

  • Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
  • Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
  • A serious adverse reaction after a previous (influenza) vaccination.
  • A history of Guillain-Barré syndrome.
  • Known to be allergic to constituents of the study vaccines.

Treatment and study plan

influenza vaccine

Biological

surface antigen, inactivated, prepared in cell cultures

Primary outcomes

  1. Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Abbott Biologicals

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 21, 2009
Registry last updated
Aug 26, 2011

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.

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