Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine Administered by the Intramuscular Route in Subjects 60 Years of Age and Older
- Conditions
- FluInfluenza10047438
- Registration Number
- NL-OMON48124
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 340
- Sixty years of age and older on the day of inclusion;
- Able to attend all scheduled visits and to comply with all trial procedures
- Participant is pregnant, or lactating, or of childbearing potential and not
using an effective method of contraception or abstinence from at least 4 weeks
prior to vaccination until at least 4 weeks after vaccination. To be considered
of non-childbearing potential, a female must be post-menopausal for at least 1
year, or surgically sterile;
- Participation at the time of study enrollment (or in the 4 weeks [28 days]
preceding the trial vaccination) or planned participation during the present
trial period in another clinical trial investigating a vaccine, drug, medical
device, or medical procedure;
- Receipt of any vaccine in the 4 weeks (28 days) preceding the trial
vaccination or planned receipt of any vaccine prior to V02;
- Previous vaccination against influenza (in the previous 6 months) with either
the trial vaccine or another vaccine;
- Receipt of immune globulins, blood or blood-derived products in the past 3
months;
- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation
therapy, within the preceding 6 months; or long-term systemic corticosteroid
therapy (prednisone or equivalent for more than 2 consecutive weeks within the
past 3 months);
- Known systemic hypersensitivity to any of the vaccine components, or history
of a life-threatening reaction to the vaccines used in the trial or to a
vaccine containing any of the same substances;
- Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM)
vaccination based on Investigator*s judgement
- Alcohol or substance abuse that, in the opinion of the Investigator might
interfere with the trial conduct or completion
- Chronic illness that, in the opinion of the Investigator, is at a stage where
it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to Investigator
judgment) or febrile illness (temperature * 38.0°C) on the day of vaccination.
A prospective participant should not be included in the study until the
condition has resolved or the febrile event has subsided
- Identified as an Investigator or employee of the Investigator or study center
with direct involvement in the proposed study, or identified as an immediate
family member (ie, parent, spouse, natural or adopted child) of the
Investigator or employee with direct involvement in the proposed study
- Personal or family history of Guillain Barré syndrome (GBS);
- Neoplastic disease or any hematologic malignancy (except localized skin or
prostate cancer that is stable at the time of vaccination in the absence of
therapy and participants who have a history of neoplastic disease and have been
disease free for * 5 years)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> Hemagglutination inhibition antibody titers obtained on D28 for each age group<br /><br>and for subjects in each vaccine group.</p><br>
- Secondary Outcome Measures
Name Time Method