Examples of using Reactogenicity in English and their translations into Slovak
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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 concurrently.
In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received two half adult i. e.
Reactogenicity was higher in children receiving whole cell pertussis vaccines concomitantly.
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 after the second 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-day interval showed lower immune responses andslightly more local reactogenicity than two doses given at a 28-day interval.
Regardless of age, reactogenicity was higher after the first dose than after the second vaccination.
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.
A booster dose with TritanrixHepB will give rise to increased reactogenicity as would be expected for a booster during the second year of life.
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 of Fendrix in a total of 82 pre-haemodialysis and haemodialysis patients was generally comparable to that seen in healthy subjects.
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.
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 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.
Safety and reactogenicity evaluations were performed for all subjects during the first 3 weeks following vaccination and SAEs have been collected for approximately 3100 vaccinees during six months of follow-up.
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 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.
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.
Additional data on reactogenicity are available from clinical studies in healthy subjects of various age groups from 6 months of age upwards who received an AS03-containing vaccine containing HA from H1N1v manufactured using a different process.
In clinical studies that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two 0.25 ml doses(half adult dose) or two 0.5 ml doses(adult dose)(21 days apart) of Pandemrix(H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table.
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.
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.
In a clinical study that evaluated the reactogenicity of the first 0.5 ml dose of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in healthy adults aged 18- 60(N=120) and above 60 years(N=120) the frequency of adverse reactions was similar between age groups, except for redness(more common in subjects agedgt; 60 years) and shivering and sweating(more common in subjects aged 18-60 years).