Norfolk, Virginia, 23507, United States
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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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
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®)
Biological0.5 mL, intramuscular
Other names: Fluzone®
Primary outcomes
-
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
-
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
-
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.
-
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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