Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine
Summary
The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.
Study Design
Observational Model: Ecologic or Community, Time Perspective: Prospective
Conditions
Influenza
Intervention
H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)
Location
General Practice
Bludenz
Austria
6700
Status
Recruiting
Source
Baxter Healthcare Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00950456
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Influenza A Virus, H1n1 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 1 and neuraminidase 1. The H1N1 subtype was responsible for the Spanish flu pandemic of 1918.
Influenza A Virus, H3n2 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 3 and neuraminidase 2. The H3N2 subtype was responsible for the Hong Kong flu pandemic of 1968.
Influenza A Virus, H2n2 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 2 and neuraminidase 2. The H2N2 subtype was responsible for the Asian flu pandemic of 1957.
Poliovirus Vaccine, Oral
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)
Pertussis Vaccine
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)
Clinical Trials
A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents
The purpose of this study is to determine the preferred dose of H1N1 pandemic influenza vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of immunogenici...
A/H1N1 Immunogenicity and Safety in Adults
The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and ol...
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...
A Clinical Trial With Influenza A/H1N1 Vaccines
A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (1...
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...
PubMed Articles
Vaccination with the non-adjuvanted split-virion A/California/7/2009 influenza vaccine (pandemic H1N1 2009 vaccine) began in October 2009 in Japan. We studied how prior vaccination with a seasonal tri...
A/H5N1 Prepandemic Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated) Vepacel®.
The influenza A subtype H5N1 virus is a likely causative agent for the next human influenza pandemic. Pandemic influenza vaccine production can begin only after a novel pandemic virus emerges. Cell-ba...
The development of vaccine viruses against pandemic A(H1N1) influenza.
Wild type human influenza viruses do not usually grow well in embryonated hens' eggs, the substrate of choice for the production of inactivated influenza vaccine, and vaccine viruses need to be develo...
Optimal vaccination strategies for 2009 pandemic H1N1 and seasonal influenza vaccines in humans.
A randomized clinical trial was conducted to assess whether the immunogenicity of seasonal and pandemic (H1N1/09) influenza vaccines is affected by the order of vaccine administration. 151 healthy adu...
Determinants of 2009 A/H1N1 Influenza Vaccination Among Pregnant Women in Hong Kong.
During the 2009-2010 A/H1N1 influenza pandemic, pregnant women infected with the virus experienced excess morbidity and mortality when compared with other groups. Once a vaccine was available, pregnan...
