CompletedPhase 3

Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

United States11,404 participantsStarted 2007-10

Plain-language summary

The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in healthy adults 18 to 49 years of age.

Who can participate

Age range18 Years – 49 Years

SexALL

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Inclusion criteria

✓. subjects 18 to 49 years of age;
✓. in good health as determined by medical history and physical examination;
✓. able and willing to provide written informed consent prior to any study procedure;
✓. able to comply with all study procedures, including availability and willingness to be actively followed throughout the ensuing influenza season with weekly telephone calls and to comply with the need for prompt collection of nasal and throat specimens in the event of influenza symptoms.

Exclusion criteria

✕. history of anaphylaxis or serious reaction after administration of any vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, kanamycin, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
✕. any health condition for which the inactivated vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP) including chronic diseases of the pulmonary or cardiovascular systems (including asthma), chronic metabolic diseases (including diabetes), renal dysfunction, hemoglobinopathies, immune deficiency disease (including HIV infection) or on-going immunosuppressive therapy;
✕. employment in professions prone to influenza transmission to or from high-risk populations (this exclusion specifically includes nurses, physicians, all other healthcare workers with direct patient contact; and police, fire, and rescue personnel); or living in the same household as an immunocompromised person;
✕. history of Guillain-Barré syndrome;
✕. bleeding diathesis;
✕. receipt of another investigational agent within 90 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end of the study;
✕. receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
✕. laboratory-confirmed influenza disease within 6 months prior to Visit 1;

What they're measuring

Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains

Timeframe: 6 Months

Trial details

NCT IDNCT00630331

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-07

Results submitted2012-11-21

View on ClinicalTrials.gov More Influenza trials