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OpenTrials
Completed

NCT Number: NCT00889889

Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination

Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination

Completed

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 45690, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Willing and able to give informed consent and able to adhere to all protocol required study procedures.
  • Men and women aged >= 18 and <= 64 years.
  • Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

Exclusion criteria

  • Known to be allergic to constituents of the vaccine.
  • A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
  • Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.

Treatment and study plan

Cell-Derived Trivalent Subunit Influenza Vaccine

Biological

surface antigen, inactivated, prepared in cell cultures

Placebo

Biological

Placebo

Primary outcomes

  1. To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.

    Time frame: 3 weeks

  2. To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.

    Time frame: 6 months

Secondary outcomes

  1. To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.

    Time frame: 6 months

  2. To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.

    Time frame: 3 weeks

  3. To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Abbott Biologicals

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Cell-Derived Trivalent Subunit Influenza Vaccine in Subjects Aged >= 18 Years and <= 64 Years During Two Consecutive Years.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 29, 2009
Registry last updated
Oct 25, 2013

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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