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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743275
• Other study ID #: GRC41
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2008
• Last updated: January 17, 2014
• Start date: August 2008
• Est. completion date: November 2008

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)
0.5 mL, intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.	Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering	Days 0-3 post-vaccination	Yes
Primary	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	No
Primary	Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)	Seroprotection was defined as post-vaccination titer value of = 1:40.	21 days post-vaccination	No
Primary	Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)	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	21 days post-vaccination	No

External Links

•   Link
•   Link