Flumist (Influenza Virus Vaccine Live Intranasal) - Summary

FLUMIST SUMMARY

Influenza Virus Vaccine Live, Intranasal (FluMist™) is a live trivalent nasally administered vaccine intended for active immunization for the prevention of influenza.

FOR NASAL ADMINISTRATION ONLY

FluMist is indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5-17 years of age, and healthy adults, 18-49 years of age.

FluMist is not indicated for immunization of individuals less than 5 years of age, or 50 years of age and older, or for therapy of influenza, nor will it protect against infections and illness caused by infectious agents other than influenza A or B viruses.

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NEWS HIGHLIGHTS

Media Articles Related to Flumist (Influenza Virus Vaccine)

CSL Biotherapies Obtains FDA Licensure For Use Of Its Thimerosal-Free Pandemic Influenza A (H1N1) 2009 Monovalent Vaccine In Children
Source: Flu / Cold / SARS News From Medical News Today [2009.11.12]
CSL Biotherapies, a subsidiary of CSL Limited (ASX: CSL), one of the world's leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company's application for accelerated approval of its seasonal flu vaccine, Afluria® (Influenza Virus Vaccine) for use in the pediatric population aged 6 months and older.

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Published Studies Related to Flumist (Influenza Virus Vaccine)

Comparative efficacy of inactivated and live attenuated influenza vaccines. [2009.09.24]
BACKGROUND: The efficacy of influenza vaccines may vary from year to year, depending on a variety of factors, and may differ for inactivated and live attenuated vaccines... CONCLUSIONS: In the 2007-2008 season, the inactivated vaccine was efficacious in preventing laboratory-confirmed symptomatic influenza A (predominately H3N2) in healthy adults. The live attenuated vaccine also prevented influenza illnesses but was less efficacious. (ClinicalTrials.gov number, NCT00538512.) 2009 Massachusetts Medical Society

A probiotic fermented dairy drink improves antibody response to influenza vaccination in the elderly in two randomised controlled trials. [2009.09.18]
BACKGROUND: Influenza vaccination is recommended for the elderly in many countries, but immune responses are weaker compared to younger adults. OBJECTIVE: To investigate the impact of daily consumption of a probiotic dairy drink on the immune response to influenza vaccination in an elderly population of healthy volunteers over 70 years of age... CONCLUSION: These studies demonstrate that daily consumption of this particular probiotic product increased relevant specific antibody responses to influenza vaccination in individuals of over 70 years of age and may therefore provide a health benefit in this population.

Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity. [2009.09.15]
BACKGROUND: This study assessed the safety, reactogenicity, and immunogenicity of an injectable cell culture-derived influenza vaccine (CCIV), compared with those of an injectable egg-based trivalent inactivated influenza vaccine (TIV)... CONCLUSIONS: The safety, reactogenicity, and immunogenicity of the CCIV and the egg-based TIV are comparable.

Safety and immunogenicity of a novel influenza subunit vaccine produced in mammalian cell culture. [2009.09.15]
BACKGROUND: Immunization remains the best prevention strategy for influenza, but production constraints for egg-based influenza vaccines have prompted the development of innovative cell culture manufacturing processes. Here, we describe a novel cell culture-derived influenza vaccine (CCIV) produced in Madin-Darby canine kidney cells... CONCLUSIONS: CCIV was well tolerated and highly immunogenic in adults 18 years of age or older. Cell culture may offer greater flexibility of supply during periods of high demand for both seasonal and pandemic vaccines.

A multinational, randomized, placebo-controlled trial to assess the immunogenicity, safety, and tolerability of live attenuated influenza vaccine coadministered with oral poliovirus vaccine in healthy young children. [2009.09.04]
Live attenuated influenza vaccine (LAIV) provides a useful tool to rapidly immunize populations in the developing world to prevent influenza outbreaks. In this noninferiority trial conducted in Asia and South America, where oral poliovirus vaccine (OPV) is still used, 2503 children aged 6 to <36 months with three polio immunizations were randomized to receive LAIV+OPV, placebo+OPV, or LAIV only...

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Clinical Trials Related to Flumist (Influenza Virus Vaccine)

Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children [Completed]

- To compare immune responses to measles, mumps, rubella, and varicella antigens following

vaccination in children who receive FluMist concurrently with MMRIIÃ’ and VARIVAXÃ’ and in children who receive an intranasal placebo mist concurrently with MMRIIÃ’ and VARIVAXÃ’ (Group 2 vs. Group 1).

- To compare immune responses to the three strains of influenza (H1N1, H3N2, and B)

following a two dose regimen of FluMist in children who receive the initial FluMist dose concurrently with MMRIIÃ’ and VARIVAXÃ’ and in children who receive two doses of FluMist alone (Group 2 vs. Group 3).Secondary:

- To assess the safety and tolerability of concurrent administration of FluMist with

MMRIIÃ’ and VARIVAXÃ’.

Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children [Active, not recruiting]

Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children [Completed]
The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination.

Immunogenicity and Safety of an Adjuvanted Inactivated Subunit Influenza Vaccine to Those of a Non-Adjuvanted Inactivated Subunit Influenza Vaccine, When Administered to Adults Affected by Chronic Diseases [Active, not recruiting]
This phase III is designed to confirm the previous trial results evaluating the safety, clinical tolerability and immunogenicity of the 2006-2007 formulation of Novartis Vaccines' adjuvanted influenza vaccine and subunit influenza vaccine in adults with underlying chronic diseases.

Safety and Immunogenicity of FluLavalâ„¢ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults [Completed]
The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.

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