Vaccine
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Multicenter Study
Clinical effectiveness of 23-valent pneumococcal polysaccharide vaccine against pneumonia in middle-aged and older adults: a matched case-control study.
The 23-valent polysaccharide pneumococcal vaccine is currently recommended in elderly and high-risk adults. Its efficacy against invasive pneumococcal disease has been demonstrated, but its effectiveness in preventing pneumonia remains uncertain. This study assessed the clinical effectiveness of vaccination against pneumonia among middle-aged and older adults. ⋯ Vaccination was effective against bacteremic cases (OR: 0.34; 95% CI: 0.27-0.66) as well as nonbacteremic cases (OR: 0.58; 95% CI: 0.39-0.86). Vaccine effectiveness was highest against bacteremic infections caused by vaccine types (OR: 0.24; 95% CI: 0.09-0.66). These findings confirm the effectiveness of the vaccine against invasive disease, but they also support the benefit of vaccination in preventing nonbacteremic pneumococcal pneumonia.
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Randomized Controlled Trial Multicenter Study
Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults.
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Randomized Controlled Trial Multicenter Study
Antibody induction by virosomal, MF59-adjuvanted, or conventional influenza vaccines in the elderly.
In a randomized, observer-blind, three-arm, parallel group, multi-centre trial including 386 elderly subjects in four countries, the immunogenicity and safety was studied of three different trivalent inactivated surface antigen (subunit) influenza vaccine types: a conventional subunit influenza vaccine (SIV, brand: Influvac and two newer vaccines: a MF59-adjuvanted subunit influenza vaccine (adSIV, brand: Fluad and a virosomal subunit influenza vaccine (vSIV, brand: Invivac. All vaccines were trivalent containing 15 microg hemagglutinin of each virus strain as recommended by the World Health Organization for the 2004-2005 season. The study was designed to demonstrate the serological non-inferiority of vSIV to both adSIV and SIV in elderly persons. ⋯ Vaccinations caused only little inconvenience as measured by questionnaire. In general, all vaccines were safe and well tolerated. In this trial, virosomal vaccine had similar immunogenicity to MF59-adjuvanted and conventional subunit vaccine and was considerably less reactogenic than the MF59-adjuvanted vaccine in the elderly.
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Randomized Controlled Trial Multicenter Study
Randomized, double-blind, multicenter study of the immunogenicity and reactogenicity of 17DD and WHO 17D-213/77 yellow fever vaccines in children: implications for the Brazilian National Immunization Program.
Vaccines against yellow fever currently recommended by the World Health Organization contain either virus sub-strains 17D or 17DD. In adults, the 17DD vaccine demonstrated high seroconversion and similar performance to vaccines manufactured with the WHO 17D-213/77 seed-lot. In another study, 17DD vaccine showed lower seroconversion rates in children younger than 2 years. ⋯ This finding in very young children is not consistent with data from studies with 17D vaccines. A multicenter, randomized, double-blind clinical trial was designed (1) to compare the immunogenicity and reactogenicity of two yellow fever vaccines: 17DD (licensed product) and 17D-213/77 (investigational product) in children aged 9-23 months; (2) to assess the effect of simultaneous administration of yellow fever and the measles-mumps-rubella vaccines; and (3) to investigate the interference of maternal antibodies in the response to yellow fever vaccination. The anticipated implications of the results are changes in vaccine sub-strains used in manufacturing YF vaccine used in several countries and changes in the yellow fever vaccination schedule recommendations in national immunization programs.
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Randomized Controlled Trial Multicenter Study Comparative Study
Safety and immunogenicity of a zoster vaccine in varicella-zoster virus seronegative and low-seropositive healthy adults.
To evaluate immunogenicity and tolerability of a live attenuated zoster vaccine in varicella-zoster virus (VZV) seronegative or low-seropositive adults > or = 30 years of age. ⋯ The zoster vaccine appears to be immunogenic and generally well tolerated in healthy adults > or = 30 years of age, regardless of initial VZV antibody serostatus.