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Influenza, Human clinical trials

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NCT ID: NCT00900991 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Children

Start date: n/a
Phase: Phase 2
Study type: Interventional

A single center, stratified, randomized and double-blind phase II clinical trial was conducted in children to evaluate the safety and immunogenicity of an split-virion pandemic influenza A vaccine (H5N1).

NCT ID: NCT00900588 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Adolescents

Start date: n/a
Phase: Phase 2
Study type: Interventional

A single center, stratified, randomized and double-blind phase II clinical trial was conducted in adolescents to evaluate the safety and immunogenicity of a split-virion pandemic influenza A vaccine (H5N1).

NCT ID: NCT00895544 Completed - Influenza Clinical Trials

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

Start date: May 2009
Phase: Phase 1/Phase 2
Study type: Interventional

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 schedule.

NCT ID: NCT00893906 Completed - Influenza Clinical Trials

Inactivated Influenza Vaccine Effectiveness in Tropical Africa

Start date: May 2009
Phase: Phase 4
Study type: Interventional

Influenza, a highly communicable acute respiratory disease, is one of the major infectious disease threats to the human population. In Africa, information on the occurrence of influenza and its disease burden is seriously lacking. Such data would be important in determining the contribution of influenza to the more than two million annual pneumonia deaths among children globally, mostly in the developing world, and the potential number of deaths that could be prevented by influenza vaccination. A single dose of trivalent inactivated influenza vaccine (TIV) is 70 to 90 percent effective in preventing influenza in healthy older children and young and middle-aged adults, but is less efficacious in young children and the elderly. Young children who suffer substantial influenza morbidity and are unlikely to have pre-existing immunity should receive two doses of TIV to provide adequate immunity. Because family studies of influenza transmission conducted during the 1970's found children to be the main introducers of influenza into households, vaccination of children may decrease the chances of spreading influenza to contacts. Mass vaccination of schoolchildren has been correlated with reduced respiratory illness in unvaccinated persons suggesting that immunization of children on a larger scale can affect community epidemics. In temperate industrialized countries with seasonal disease, influenza vaccine is given annually, prior to the influenza season, and generally targeted to individuals with the highest risk of severe disease. Influenza prevention strategies may need to differ in tropical developing countries due to a variety of reasons. Given the varying influenza circulation patterns, it is unknown which hemisphere vaccine formulation will provide year-round protection against the diverse strains that may exist in tropical countries. Persons residing in developing countries also may have nutritional deficiencies or underlying diseases and infections that affect vaccine immunogenicity. Consideration must be given to programmatic issues as well. Adolescent and adult preventive health services are poorly developed in many countries, and thus a strategy that targets children may be the most feasible option. In addition, vaccinating children may be the most cost-effective option, as it has the potential to provide direct benefit to those vaccinated, as well as indirect benefits to unvaccinated members of the population. Thus, an influenza vaccine effectiveness study in a tropical developing country population will help to elucidate burden of seasonal influenza and may inform optimal use of vaccine for either seasonal and pandemic situations. Thus, this study in Senegal will to evaluate the direct effects of TIV in reducing the occurrence of laboratory-confirmed influenza among children who receive it as well as the potential indirect effects experienced by the population as a result of reducing transmission among children.

NCT ID: NCT00889889 Completed - Influenza Clinical Trials

Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination

Start date: May 2009
Phase: Phase 2
Study type: Interventional

Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination

NCT ID: NCT00884182 Completed - Influenza Clinical Trials

Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children

Start date: April 2009
Phase: Phase 2
Study type: Interventional

This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic. Study objectives: - To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule. - To describe the immune response after each vaccination in subjects receiving study vaccine.

NCT ID: NCT00884117 Completed - Influenza Clinical Trials

Influenza Resistance Information Study

IRIS
Start date: January 2009
Phase: N/A
Study type: Observational

This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.

NCT ID: NCT00883012 Completed - Clinical trials for Influenza With Pneumonia, Influenza Virus Identified

Influenza Vaccine in HIV Infected Children

Start date: February 2009
Phase: Phase 4
Study type: Interventional

Influenza associated pneumonia causes significant morbidity in young HIV-infected children. Although annual vaccination against influenza is recommended for HIV infected children, it has not been implemented as routine care, due to the lack of data on disease burden and vaccine efficacy. This study aims at determining the effectiveness of influenza vaccination in HIV infected children in South Africa.

NCT ID: NCT00881842 Completed - Influenza Clinical Trials

Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 09/10 Season

Start date: June 2009
Phase: Phase 3
Study type: Interventional

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of subjects in good health: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).

NCT ID: NCT00880659 Completed - Human Influenza Clinical Trials

Bangladesh Secondary Transmission Handwashing Protocol

Start date: June 2009
Phase: Phase 2
Study type: Interventional

The next influenza pandemic is expected to spread rapidly in resource-poor settings. Influenza viruses spread from human-to-human via large respiratory droplets. Transmission via large-particle respiratory droplets is believed to be mediated by close contact between infected and susceptible persons or contact with droplet-contaminated fomites. Close contact between infected and susceptible persons may consist of skin-to-skin contact (e.g., via hands) or inhalation of respiratory droplets (e.g., due to talking, coughing, or sneezing by the infected person). Airborne transmission, which is expected to result in transmission over long distances (>1 meter) and which would be mediated by ventilation, is believed to be uncommon. Therefore, the greatest risk of transmission from personal contact comes from those people who are closest to an index case, such as contacts living in the same household. There are, to date, no published estimates of the secondary attack ratio of influenza among household contacts of index case-patients in low-income countries. Moreover, the investigators do not have data on the risk factors for secondary transmission of influenza from index case-patients to their household contacts. There is some data for the benefits of promoting handwashing with soap on the risk of all-cause acute respiratory illness among children < 15 years old in a resource-poor setting in Pakistan. But, the investigators do not have evidence that promoting handwashing with soap will acutely reduce the risk of secondary transmission. Therefore, the investigators propose to conduct a study in rural Bangladesh to assess the following: - The secondary attack ratio of influenza among household contacts of an index case-patient with influenza - The risk factors for secondary transmission of influenza from an index case-patient to household contacts - The impact of promoting handwashing with soap on the risk of secondary transmission of influenza from an index case-patient to household contacts - The impact of handwashing promotion on handwashing behavior six months after intervention - The impact of handwashing promotion on the prevalence of respiratory infections, diarrhea and influenza