Advertisement

Topics

Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and Adolescents

2014-08-27 03:16:33 | BioPortfolio

Summary

The purpose of this study is to assess the safety and immunogenicity (i.e. primary immune response, immunogenicity of two different doses, antibody persistence 360 days after the first vaccination, immune response to a heterologous booster given on Day 360) of a Vero cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years.

Study Design

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

Conditions

Influenza, Avian

Intervention

H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation

Location

Espoo Vaccine Research Clinic
Espoo
Finland
02100

Status

Recruiting

Source

Baxter Healthcare Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:33-0400

Clinical Trials [3254 Associated Clinical Trials listed on BioPortfolio]

Phase 3 Immunogenicity and Safety Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

The objectives of this study are to assess the immune response as well as the safety and tolerability of an H5N1 influenza vaccine in an adult and elderly population. Further, the study wi...

Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults

The main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost sched...

Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

The objectives of this Phase I/II study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult populat...

Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived)

The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a s...

Safety and Immunogenicity Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

The objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be enrolled s...

PubMed Articles [21297 Associated PubMed Articles listed on BioPortfolio]

A neuraminidase activity-based microneutralization assay for evaluating antibody responses to influenza H5 and H7 vaccines.

Outbreaks of the highly pathogenic avian influenza H5N1 and H7N9 viruses have spurred an unprecedented research effort to develop antivirals and vaccines against influenza. Standardized methods for va...

Fatal Avian Influenza A/H5N1 Infection in a 36-Week Pregnant Woman Survived by her Newborn - Soc Trang, Vietnam, 2012.

Outbreaks of H5N1 Avian Influenza (AI) emerged in Indonesia, Thailand and Viet Nam during 2003- 2005. Its severe impact has been reported; the Food and Agriculture Organization (FAO) and World Bank (W...

Combined use of live-attenuated and inactivated influenza vaccines to enhance heterosubtypic protection.

The limited protection of current commerical vaccines necessitates the investigation of novel vaccine strategies for unpredictable outbreaks. To investigate the feasibility of using vaccines derived f...

Multi-clade H5N1 virus-like particles: Immunogenicity and protection against H5N1 virus and effects of beta-propiolactone.

During the past decade, H5N1 highly pathogenic avian influenza (HPAI) viruses have diversified genetically and antigenically, suggesting the need for multiple H5N1 vaccines. However, preparation of mu...

Glycan-masking hemagglutinin antigens from stable CHO cell clones for H5N1 avian influenza vaccine development.

Refocusing of B cell responses can be achieved by preserving the overall fold of the antigen structure but selectively mutating the undesired antigenic sites with additional N-linked glycosylation mot...

Medical and Biotech [MESH] Definitions

A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 5 and neuraminidase 1. The H5N1 subtype, frequently referred to as the bird flu virus, is endemic in wild birds and very contagious among both domestic (POULTRY) and wild birds. It does not usually infect humans, but some cases have been reported.

A CELL LINE derived from the kidney of the African green (vervet) monkey, (CERCOPITHECUS AETHIOPS) used primarily in virus replication studies and plaque assays.

A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)

A suspension of killed Bordetella pertussis organisms, used for immunization against pertussis (WHOOPING COUGH). It is generally used in a mixture with diphtheria and tetanus toxoids (DTP). There is an acellular pertussis vaccine prepared from the purified antigenic components of Bordetella pertussis, which causes fewer adverse reactions than whole-cell vaccine and, like the whole-cell vaccine, is generally used in a mixture with diphtheria and tetanus toxoids. (From Dorland, 28th ed)

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.

More From BioPortfolio on "Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and Adolescents"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial