Examples of using Reactogenicity in English and their translations into Slovenian
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No data are available at present on reactogenicity after a second half adult i. e.
Reactogenicity was higher in children receiving whole cell pertussis vaccines concomitantly.
In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received two half adult i. e.
Reactogenicity after a third dose, administered 12 months after the second dose, was higher than after both first and second dose.
Those trials have shown that the safety and reactogenicity profile of the liquid formulation is comparable to the lyophilised formulation.
Reactogenicity after a third dose, administered 12 months following the first dose, was higher than after both first and second dose.
A clinical study(D-H5N1-009) evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult i. e.
Two doses of IMVANEX given at a 7-dayinterval showed lower immune responses and slightly more local reactogenicity than two doses given at a 28-day interval.
In a clinical study that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received a single half adult i. e.
In the 12-14 months age group who received 2 doses of Nimenrix given 2 months apart, the first and second doses were associated with similar local andsystemic reactogenicity.
Regardless of age, reactogenicity was higher after the first dose than after the second vaccination.
Data in children andadolescents 3-17 years suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
The reactogenicity profile of Fendrix in healthy subjects was generally comparable to that seen in pre- haemodialysis and haemodialysis patients.
In a study, in 300 subjects aged from 12 years up to andincluding 15 years, the reactogenicity profile of Ambirix was compared to that of the three-dose combined vaccine.
The reactogenicity profile and rates of adverse events among subjects aged 56-65 years who received Menveo(N=216), were similar to that observed in Menveo recipients subjects aged 11-55.
The approval was based on results from clinical trials,which investigated the immunogenicity and reactogenicity of Hexavac when administered according to specific primary and booster vaccination schedules.
Clinical trials involving the administration of 2,476 doses of Fendrix to 82 pre-haemodialysis and haemodialysis patients and to 713 healthy subjects15 years of age allowed to document the reactogenicity of the vaccine.
The administration of a second half adult oran adult dose did not enhance the reactogenicity, except for rates of general symptoms which were higher after the second dose, particularly for rates of fever in< 6 year olds.
Reactogenicity was also evaluated in healthy adults aged 18-60 years who received a first 0.5 ml dose of either Arepanrix(H1N1)(N=167) or an AS03-containing vaccine containing HA from H1N1v manufactured using a different process(N=167).
As an identified risk, an appropriate warning should be included in section 4.4. Moreover section4.8 should be revised to reflect reactogenicity data from the three paediatric studies D-Pan H5N1-009, -013 and 032.
In clinical studies that evaluated the reactogenicity in children 10 to 17 years of age who received either two 0.5 ml doses(adult dose) or two 0.25 ml doses(half adult dose)(21 days apart) of Pandemrix(H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:.
Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinicalimmunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
In order to further investigate the safety and reactogenicity of Pandemic influenza vaccine H5N1 MedImmune, the MAH should conduct an open-label single arm interventional study to evaluate the safety and immunogenicity of P/LAIV in children and adolescents from 12 months to less than 18 years of age during the next declared pandemic.
Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity,safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
In clinical studies that evaluated reactogenicity in adults aged 18 years and above who received two 0.5 ml doses of Pandemrix(H1N1)v, higher rates of general solicited symptoms(such as fatigue, headache, arthralgia, myalgia, shivering, sweating and fever) were observed after the second dose compared to the first dose.
Data obtained with the H5N1 vaccines will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity,safety and reactogenicity data obtained with H5N1 vaccines are relevant for the pandemic and prepandemic vaccines.
Local reactogenicity of primary vaccination course was similar in infants< 12 months of age and in children> 12 months of age except for injection site pain for which the incidence increased with increasing age: pain was reported by more than 39% of the infants< 12 months of age and by more than 58% of the children> 12 months of age.