Exemplos de uso de Reference vaccine em Inglês e suas traduções para o Português
{-}
-
Medicine
-
Colloquial
-
Official
-
Financial
-
Ecclesiastic
-
Ecclesiastic
-
Computer
-
Official/political
Relative potency units defined against a reference vaccine.
The National Reference Vaccine(VRN) was produced in BHK cells, C 13, with the Pasteur vírus PV.
Relative potency(ELISA test)by comparison with a reference vaccine.
Issues that related to the equivalence of reference vaccine batches arose during subsequent variations.
VrHB-IB showed a similar reactogenicity andsafety profile to that of the reference vaccine.
Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Porcine circovirus type 2 ORF2 protein: minimum RP* 1.0, maximum RP* 3.75* Relative Potency(ELISA test)by comparison with a reference vaccine.
Relative potency(mice potency test)compared to a reference vaccine that was shown efficacious in the target animal species.
In both trials,newborns were randomly allocated to the experimental or control(reference vaccine) groups.
The reference vaccine changes included in this referral relate to the replacement of batch 8500 with 9097 and the subsequent replacement of batch 9097 with 9861.
The hepatitis B vaccine manufactured by Instituto Butantan showed a similar safety profile to that of the reference vaccine.
CONCLUSIONS: The reformulated VrHB-IB is considered equivalent to the reference vaccine, and its use is recommended in newborns.
Relative Potency unit determined by ELISA antigen quantification(in vitro potency test)compared to a reference vaccine.
In the first trial,the difference in efficacy between VrHB-IB and the reference vaccine was 6% Table 3, i.e., higher than the prestated equivalence margin of 5%. However, this value was within the 95% confidence interval of the difference in proportions.
Porcine circovirus type 2 ORF2 protein: minimum RP* 1.0 maximum RP* 3.75* Relative Potency(ELISA test)by comparison with a reference vaccine.
CONCLUSIONS: The Brazilian vaccine was considered to be equivalent to the reference vaccine and its use is recommended for adults.
In the group that received theIB vaccine(20 μ g), 79.8% of subjects were effectively immunized, vs. 92.4% of those receiving the reference vaccine.
Subsequent trials have shown VrHB-IB to be equivalent in efficacy to the reference vaccine in children from one to 11 years of age,"less immunogenic, but acceptable for use in newborns, adolescents, and young adults," and significantly less immunogenic in adults aged 31 to 40 years.
The aim of the present study was to analyze the immunogenicity of the reformulated VrHB-IB in healthy adults,in comparison with the reference vaccine.
During assessment of a Type II variation for changing the mouse potency test to comply with the revised Ph. Eur monograph for erysipelas vaccines, vaccine batch 8500 was accepted as being a reference vaccine and therefore this batch and those prior to it have to be accepted as being compliant with the conditions of the Marketing Authorisations for both products.
It is of great importance to the effective control of the quality of this product before its market entrance because it is necessary to perform the test of biological power with the use of a reference vaccine.
Newborns randomized to the experimental group received VrHB-IB, andthose in the control group received the reference vaccine, a Engerix B®, produced by Glaxo Smith Kline.
In both cases the Marketing Authorisation Holder(MAH)has shown that these batches qualify as reference vaccine batches because.
Active substance: Inactivated bluetongue virus, serotype 8,strain BTV-8/BEL2006/02 RP*≥ 1*Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
The goals of the present study is to compare the NIH("National Institute of Health") and the indirect ELISA tests to the Habel test andproduce the National Reference Vaccine(VRN) experimentally, to be used in the NIH.
Where an outbreak of foot-and-mouth disease has been confirmed and the serotype of the virus was identified,that virus shall be antigenically characterised in relation to the reference vaccine strains, where necessary with the assistance of the Community Reference Laboratory.
Our present results in newborns, along with those of another trial conducted simultaneously, by the same team, in a sample of adults,allow us to conclude that the performance of VrHB-IB is identical to that of the reference vaccine, warranting its large-scale use in the control of an important endemic disease of in Brazil.
The Marketing Authorisation(s)should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
The CVMP, therefore, recommended that the Marketing Authorisation should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.