Clinical Studies

Clinical Studies1

In the United States, one of the best methods for reducing the impact of influenza is immunoprophylaxis with vaccine. Vaccinating persons at high risk for complications each year before the onset of flu season is one of the most effective means of reducing the effect of influenza.

Pediatric Use

The immunogenicity of FLUVIRIN® (Influenza Virus Vaccine) has been established in children aged 4 to 16 years. The use of FLUVIRIN® vaccine in this age group is supported by evidence from adequate and well-controlled studies of FLUVIRIN® vaccine in adults that demonstrate the immunogenicity of FLUVIRIN® vaccine. The safety and immunogenicity of FLUVIRIN® vaccine have not been established in children <4 years of age.

Geriatric Use

Since 1997, of the total number of geriatric subjects (N=397) in clinical studies of FLUVIRIN® vaccine, 29% were 65 years and older, while 2.1% were 75 years and older. Antibody responses were lower in the geriatric population than in younger subjects. Adverse events occurred less frequently in geriatric subjects (≥65 years) than in younger adults. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Important Safety Information

FLUVIRIN® should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (egg or egg products), or to any component of FLUVIRIN®, or who has had a life-threatening reaction to previous influenza vaccinations.

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUVIRIN® should be based on careful consideration of the potential benefits and risks.

If FLUVIRIN® is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained. Prior to administration of any dose of FLUVIRIN®, the healthcare provider should review the patient’s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with FLUVIRIN® and to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

The tip caps of the FLUVIRIN® prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.

Vaccination with FLUVIRIN® may not protect all individuals. In clinical trials, the most common adverse events in adults were headache, fatigue, injection site reaction (pain, mass, redness, and induration), and malaise.


References:

  1. FLUVIRIN® (package insert). Cambridge, MA.