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Completed

NCT Number: NCT00743275

A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation.

To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Norfolk, Virginia, 23507, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant is 18 years of age or older on the day of inclusion.
  • Participant willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
  • Participant in reasonably good health as assessed by the Investigator.
  • Participant willing and able to give informed consent.
  • For a woman, inability to bear a child or negative serum/urine pregnancy test.

Exclusion criteria

  • Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
  • An acute illness with or without fever in the 72 hours preceding enrollment in the trial.
  • Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) or review of systems.
  • Self-reported history of severe adverse event to any influenza vaccine.
  • Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
  • Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 2.
  • Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.*
  • Immunocompromising condition or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months.
  • Receipt of blood or blood products within the 3 months preceding enrollment in the study.
  • Diabetes mellitus requiring pharmacological control.
  • Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
  • Person deprived of freedom by an administrative or court order (having legal or medical guardian).
  • For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
  • Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Prior personal history of Guillain-Barré syndrome. * Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies.

Treatment and study plan

Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)

Biological

0.5 mL, intramuscular

Other names: Fluzone®

Primary outcomes

  1. Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.

    Time frame: Days 0-3 post-vaccination

    Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering

  2. Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation

    Time frame: Day 0 and 21 days post-vaccination

  3. Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)

    Time frame: 21 days post-vaccination

    Seroprotection was defined as post-vaccination titer value of ≥ 1:40.

  4. Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)

    Time frame: 21 days post-vaccination

    Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 28, 2008
Registry last updated
May 16, 2016

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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