Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)

09:57 EDT 1st August 2014 | BioPortfolio

Summary

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.

Description

This Protocol Posting has been updated following Protocol amendment 1& 2, October 2009. The sections impacted are study design and outcome measures

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Influenza Infection

Intervention

Influenza investigational vaccine GSK2340274A

Location

GSK Investigational Site
Fukuoka
Japan
813-0025

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Clinical Trials [1781 Associated Clinical Trials listed on BioPortfolio]

Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults

This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenz...

Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)

The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340...

Safety and Immune Response of One-Dose of Candidate H1N1 Influenza Vaccine GSK2340274A in Adults

This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age.

Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational influenza vaccine GSK2340274A following one dose and following a second dose, u...

Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years

The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Ag...

PubMed Articles [8335 Associated PubMed Articles listed on BioPortfolio]

2012-2013 Seasonal Influenza Vaccine Effectiveness against Influenza Hospitalizations: Results from the Global Influenza Hospital Surveillance Network.

The effectiveness of currently licensed vaccines against influenza has not been clearly established, especially among individuals at increased risk for complications from influenza. We used a test-neg...

Seasonal influenza vaccine effectiveness against influenza in 2012-2013: A hospital-based case-control study in Lithuania.

Due to scarce information on seasonal influenza vaccine effectiveness (SIVE) against severe clinical influenza outcomes in risk populations, we conducted a case-control study to assess its effects aga...

Mucosal Immunization and Adjuvants.

The goal of the influenza vaccine is to prevent influenzaInfluenza virus infection and control the yearly seasonal epidemic and pandemic. However, the presently available parenteral influenza vaccine...

Influenza Vaccines: Unmet Needs and Recent Developments.

Influenza is a worldwide public health concern. Since the introduction of trivalent influenza vaccine in 1978, vaccination has been the primary means of prevention and control of influenza. Current in...

Administration Time Between Seasonal Live-Attenuated Influenza Vaccine and Trivalent Influenza Vaccine During the "Stop Flu at School" Campaign- Hawaii, 2009.

We determined whether the administration time differed between seasonal intranasal live-attenuated influenza vaccine (LAIV) and seasonal injectable trivalent inactivated influenza vaccine (TIV) during...

Medical and Biotech [MESH] Definitions

Infection of domestic and wild fowl and other BIRDS with INFLUENZA A VIRUS. Avian influenza usually does not sicken birds, but can be highly pathogenic and fatal in domestic POULTRY.

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.

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.

Membrane glycoproteins from influenza viruses which are involved in hemagglutination, virus attachment, and envelope fusion. Fourteen distinct subtypes of HA glycoproteins and nine of NA glycoproteins have been identified from INFLUENZA A VIRUS; no subtypes have been identified for Influenza B or Influenza C viruses.

A genus of the family ORTHOMYXOVIRIDAE comprising viruses similar to types A and B but less common, more stable, more homogeneous, and lacking the neuraminidase protein. They have not been associated with epidemics but may cause mild influenza. Influenza C virus is the type species.

More From BioPortfolio on "Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)"

Search BioPortfolio:
Advertisement

Relevant Topics

Infectious-diseases
Latest News Clinical Trials Research Drugs Reports Corporate
Infectious diseases are caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi; the diseases can be spread, directly or indirectly, from one person to another. Zoonotic diseases are infectious diseases of animals that can caus...

Vaccine
Latest News Clinical Trials Research Drugs Reports Corporate
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one...

Advertisement

Searches Linking to this Trial