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OpenTrials
Completed

NCT Number: NCT00599443

Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years

A controlled, double blinded study to determine the safety and reactogenicity in healthy adults of a single dose of a trivalent cell-derived influenza vaccine administered by intramuscular injection.

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Key information

Conditions

Healthy

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy female or male subjects aged ≧18 and ≦49 years
  • Willing and able to give informed consent

Exclusion criteria

  • Influenza vaccination of laboratory confirmed influenza infection within six months of informed consent,
  • presence of any significant medical condition,
  • a serious adverse reaction after a previous (influenza) vaccination,
  • underlying medical conditions for which annual influenza vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP),
  • chronic diseases requiring long-term immunosuppressive therapy

Treatment and study plan

Seasonal cell-derived influenza vaccine

Biological

0.5 mL im, single dose

Placebo comparator

Biological

0.5 mL im, single dose

Primary outcomes

  1. Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination.

    Time frame: 3 weeks

  2. Long-term safety

    Time frame: 6 months

Secondary outcomes

  1. HI antibody titers

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 23, 2008
Registry last updated
Jun 30, 2008

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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