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

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)

• Registration Number: NCT00743275
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2010-02-01
• Results First Submitted QC: 2010-02-01
• Results First Posted: 2010-02-23
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)	Participants received one dose of Fluzone® vaccine on Day 0.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)	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
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation	Day 0 and 21 days post-vaccination
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.	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
Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)	21 days post-vaccination	Seroprotection was defined as post-vaccination titer value of ≥ 1:40.