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Phase 4 N=120 Prevention

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

Influenza

Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine. — 35; 18; 34; 16 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Split, Inactivated, Trivalent Influenza vaccine (Fluzone®) (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Sanofi Pasteur, a Sanofi Company
Primary completion
Nov 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
35; 18; 34; 16; 0; 1
PRIMARY
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
26.9; 16.9; 34.9; 31.5; 28.5; 21.6
PRIMARY
Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)
88; 63; 98; 98; 82; 67
PRIMARY
Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
42; 33; 77; 84; 36; 31

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00743275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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