Advertisement

Topics

Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

2014-08-27 03:12:12 | BioPortfolio

Summary

The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Conditions

Influenza

Intervention

A trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, 2010/2011 formulation, Non-adjuvanted trivalent subunit influenza vaccine, 2010/2011 formulation

Location

Cambridge
Massachusetts
United States
02139

Status

Not yet recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:12-0400

Clinical Trials [3980 Associated Clinical Trials listed on BioPortfolio]

Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects

Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at ...

Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerabili...

Safety and Immunogenicity of Inactivated Influenza Virus Vaccine Among Healthy Children 6-12 Weeks of Age

Study of the safety and immunogenicity (antibody producing capability) comparing inactivated influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive i...

Direct and Indirect Protection by Influenza Vaccine Given to Children in India

The study described here will immunize children with trivalent influenza vaccine (TIV) and determine whether this reduces influenza illness among the immunized children and their older fam...

A Phase 2, Double-blind Study to Evaluate Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult

The objectives of this phase 2 study are to evaluate immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in 2 doses in heal...

PubMed Articles [12290 Associated PubMed Articles listed on BioPortfolio]

DNA vaccine priming for seasonal influenza vaccine in children and adolescents 6 to 17 years of age: A phase 1 randomized clinical trial.

Children are susceptible to severe influenza infections and facilitate community transmission. One potential strategy to improve vaccine immunogenicity in children against seasonal influenza involves ...

A phase 2/3 double blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of a seasonal trivalent inactivated split-virion influenza vaccine (IVACFLU-S) in healthy adults in Vietnam.

Under the WHO's Global Action Plan for Influenza Vaccines, we conducted a Phase 2-3 study of IVACFLU-S, a trivalent, seasonal inactivated influenza vaccine candidate.

Adjuvanted influenza vaccine for the Italian elderly in the 2018/19 season: an updated health technology assessment.

The elderly, defined here as subjects aged ≥ 65 years, are among at-risk subjects for whom annual influenza vaccination is recommended. For the 2018/19 season, three vaccine types are available for ...

Cumulative Clinical Experience with MF59-Adjuvanted Trivalent Seasonal Influenza Vaccine in Young Children.

To demonstrate the potential of an MF59-adjuvanted inactivated trivalent seasonal influenza vaccine (aIIV3; Fluad™), to improve the immune response in young children, we review the immunogenicity, e...

Technical guidelines for seasonal influenza vaccination in China, 2018-2019.

Seasonal influenza vaccination is the most effective way to prevent influenza virus infection and its complications. Currently, China has licensed trivalent (IIV3) and quadrivalent inactivated influen...

Medical and Biotech [MESH] Definitions

Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.

Human histocompatibility (HLA) surface antigen encoded by the A locus on chromosome 6. The HLA-A2 antigen is associated with recognition of the INFLUENZA A VIRUS.

Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.

A subtype of INFLUENZA A VIRUS with the surface proteins hemagglutinin 7 and neuraminidase 9. This avian origin virus was first identified in humans in 2013.

A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 1 and neuraminidase 2. It is endemic in both human and pig populations.

More From BioPortfolio on "Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Influenza
Influenza or 'flu' is a respiratory illness associated with infection by influenza virus. Symptoms frequently include headache, fever, cough, sore throat, aching muscles and joints. There is a wide spectrum of severity of illness ranging from min...

Vaccines
A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. It creates immunity but does not cause the disease. There are several differnt types of vaccine avalable; Killed microorganisms; which s...


Searches Linking to this Trial