ABSTRACT
OBJECTIVE: To evaluate the safety and epidemiological effect of the Freeze-dried Live attenuated varicella vaccine. METHODS: A random, double-blind control clinical trial was adopted. RESULTS: In the observation period, the incidence of varicella was 0.8 per thousand in the experimental group and 8.7 per thousand in control group. There was a significant difference (B.P=0.000017). Vaccine effectiveness (VE(%)) was 90.8%, the lower limit of 95%CI was 88.7%. CONCLUSION: The varicella vaccine produced by Changchun keygen biological products co., Ltd. was safe and effective.
Subject(s)
Chickenpox Vaccine/administration & dosage , Chickenpox/epidemiology , Chickenpox/prevention & control , Chickenpox/immunology , Chickenpox Vaccine/immunology , Child , Child, Preschool , China/epidemiology , Drug Evaluation, Preclinical , Female , Freeze Drying , Humans , Male , Vaccines, Attenuated/administration & dosage , Vaccines, Attenuated/immunologyABSTRACT
OBJECTIVE: To evaluate the Immunogenicity of Group A and Group C Meningococcal conjugate Vaccine with coupling Group B Meningococcal Outer Membrane Protein (Men B-OMP). METHODS: 458 healthy children aged 3-5 months, 6-23 months, 2-6 years and 7-24 years were given the Groups A and C conjugate Vaccine with MenB-OMP or other vaccine as control group to measure the pre-and post-vaccination Men A and C and B by Serum Bactericidal Assay (SBA) in the double-blind randomized controlled trial. RESULTS: 97.65%-100% were 4 times or greater increase in SBA titer for the healthy children given the Groups A and C conjugate Vaccine with MenB-OMP, The geometric mean titer of SBA were 1:194-1:420, which significantly higber than controls. CONCLUSION: The Group A and C conjugate Vaccine with MenB-OMP was safe and well immunogenic.
Subject(s)
Bacterial Outer Membrane Proteins/immunology , Meningitis, Meningococcal/immunology , Meningococcal Vaccines/immunology , Adolescent , Bacterial Outer Membrane Proteins/administration & dosage , Bacterial Outer Membrane Proteins/adverse effects , Child , Child, Preschool , Female , Humans , Infant , Male , Meningitis, Meningococcal/microbiology , Meningococcal Vaccines/administration & dosage , Meningococcal Vaccines/adverse effects , Neisseria meningitidis, Serogroup A/immunology , Neisseria meningitidis, Serogroup B/immunology , Neisseria meningitidis, Serogroup C/immunology , Vaccines, Conjugate/administration & dosage , Vaccines, Conjugate/adverse effects , Vaccines, Conjugate/immunology , Young AdultABSTRACT
OBJECTIVE: Using the advantages of Japanese encephalitis live attenuated and inactivated vaccine, to reduce the rate of immunization reaction and to increase the effect, we conducted a study on the strategy of immunization in Japanese encephalitis using live attenuated vaccine combined with inactivated vaccine. METHODS: Observing the safety and immune effects of different groups. RESULTS: Data on side effect showed that the rate of moderate and severe systematic reactions of the group who were inoculated with combined vaccine was 0.73%, with local reaction 1.46% while the combined rate of moderate and severe systematic reaction of the group who were inoculated with inactivated vaccine was 2.8%. Under the detection of serum neutralizing antibody, the GMT rose from 1:1.05 - 1:3.35 before vaccination to 1:47.34 - 1:101.30 after vaccination in the different groups. Neutralizing antibody was detected in 97.67% of the combined group. There was a significant difference by comparing neutralizing antibody seroconversion rate of the combined group with the inactivated group (chi(2) = 3.89, P < 0.05), but no significant difference with attenuated group (chi(2) = 0.74, P > 0.05). CONCLUSION: Results showed that in children who previously had been immunized with two doses of inactivated vaccine, the booster administration of live attenuated vaccine was both effective and safe.
