ABSTRACT
This study evaluates the safety and efficacy against severe rotavirus gastroenteritis of the oral live attenuated human rotavirus vaccine RIX4414 (Rotarix) during the first 2 years of life in Asian infants from high-income countries. Healthy infants were enrolled to receive 2 doses of RIX4414 (N=5,359) or placebo (N=5,349). From 2 weeks post-dose 2 to 2 years of age, vaccine efficacy was 96.1% (95%CI:85.1%; 99.5%) against severe rotavirus gastroenteritis, 100% (95%CI:80.8%; 100%) against wild-type G1P[8] and 93.6% (95%CI:74.7%; 99.3%) against circulating non-G1 rotavirus types. No intussusception cases were reported within 31 days post-vaccination. RIX4414 shows a good safety profile and offers high protection during the first 2 years of life with potentially significant public health impact in this population.
Subject(s)
Gastroenteritis/prevention & control , Rotavirus Infections/prevention & control , Rotavirus Vaccines/administration & dosage , Child, Preschool , Double-Blind Method , Gastroenteritis/virology , Humans , Infant , Vaccines, Attenuated/administration & dosageABSTRACT
Results of registration trial of combination vaccine for prevention of hepatitis A and B are presented. The trial was conducted in 5 centers of Russia in 2004-2005 with full accordance to good clinical practice requirements and standards for multicenter open randomized trials. Immunogenicity of studied combination vaccine Twinrix was evaluated in comparison with two simultaneously administered monovalent vaccines against hepatitis A and B (Havrix and Engerix-B) in 200 healthy subjects aged 18-40, which were seronegative to hepatitis A and B. Reactogenicity based on interviewed and non-interviewed symptoms ranged on intensity was assessed also. 1 month after completion of primary vaccination all subjects in both groups were seropositive to hepatitis A. Sero-protection level of antibodies to hepatitis B virus was detected in 98.9% of participants vaccinated with Twinrix and in 95.6% of participants vaccinated with Engerix-B and Havrix. Overall, reactogenicity of vaccines was minor, marked adverse events caused by vaccination were rare (approximately 1%). Study shows that combination vaccine against hepatitis A and B (Twinrix) at least non inferior in terms of immunogenicity, safety and tolerability to monovalent vaccines (Havrix and Engerix-B), were registered in Russia.
Subject(s)
Hepatitis A Vaccines/immunology , Hepatitis A virus/immunology , Hepatitis A/immunology , Hepatitis Antibodies/blood , Hepatitis B Antibodies/immunology , Hepatitis B Vaccines/immunology , Hepatitis B/immunology , Vaccination , Vaccines, Combined/immunology , Adolescent , Adult , Female , Hepatitis A/blood , Hepatitis A Vaccines/administration & dosage , Hepatitis B/blood , Hepatitis B Vaccines/administration & dosage , Humans , Immunization Schedule , Injections, Intramuscular , Male , Russia , Vaccines, Combined/administration & dosageABSTRACT
Modern principles of organization and planning of international clinical trials of vaccines and stages of development of domestic vaccines are presented. Factors that determine the success of large-scale clinical trials are thoroughly described. Differences between domestic registration trials and international multicenter randomized clinical trials are discussed. It has been recommended how national regulatory acts that legitimate conducting of clinical trials of both national and foreign vaccines should be harmonized.
Subject(s)
Clinical Trials as Topic/standards , Drug Approval , Vaccines , Drug Design , Guidelines as Topic , Humans , Research , RussiaABSTRACT
A blind, placebo-controlled, randomized trial showed clinical effectiveness of the preparation Impaza containing antibodies to endothelial NO synthase in ultralow doses. Impaza surpassed placebo, but was less potent than sildenafil in the ability to improve erectile function and other parameters characterizing sexual activity of men. Safety of Impaza was greater than that of other test preparations.
