(no subject)
Просто информация. Погуглила по словам "prevenar neutropenia" Нашла документ
http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/vaccinesandrelatedbiologicalproductsadvisorycommittee/ucm190736.pdf
из него
Safety Profile of Prevnar (7vPnC)
The safety evaluation 13vPnC builds upon the favorable safety profile of 7vPnC that has been
well studied and extensively documented. The carrier protein and adjuvant are also the same as
those used in the HbOC (HibTITER) vaccine (indicated for immunization against Haemophilus
influenzae type b invasive disease) that was approved for marketing in the EU and US in the
early 1990’s and meningococcal C conjugate (Meningitec, MnCC) vaccine, both of which have a
favorable safety profile. The safety of 7vPnC has been evaluated in several randomized,
controlled clinical trials in the EU and the US. The large pivotal efficacy trial in the US, with
18,927 infants vaccinated with 7vPnC found systemic reactions following 7vPnC were generally
mild and local tolerance was good, and all clinical trials confirmed this.97 In an extension to the
pivotal efficacy trial, 18,925 infants vaccinated with 7vPnC were followed for at least 5 years
after the end of the trial to compare the incidence of developmental delay, autistic spectrum
disorders, diabetes mellitus, Kawasaki disease, neutropenia, and reactive airways disease to the
controls that received MnCC vaccine. No statistically significant differences were found
between 7vPnC recipients and the control subjects. In addition, 7vPnC was found to be safe and
efficacious in 4340 pre-term and 1756 low birth weight infants in the pivotal efficacy trial
conducted at Northern California Kaiser Permanente.84,85
http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/vaccinesandrelatedbiologicalproductsadvisorycommittee/ucm190736.pdf
из него
Safety Profile of Prevnar (7vPnC)
The safety evaluation 13vPnC builds upon the favorable safety profile of 7vPnC that has been
well studied and extensively documented. The carrier protein and adjuvant are also the same as
those used in the HbOC (HibTITER) vaccine (indicated for immunization against Haemophilus
influenzae type b invasive disease) that was approved for marketing in the EU and US in the
early 1990’s and meningococcal C conjugate (Meningitec, MnCC) vaccine, both of which have a
favorable safety profile. The safety of 7vPnC has been evaluated in several randomized,
controlled clinical trials in the EU and the US. The large pivotal efficacy trial in the US, with
18,927 infants vaccinated with 7vPnC found systemic reactions following 7vPnC were generally
mild and local tolerance was good, and all clinical trials confirmed this.97 In an extension to the
pivotal efficacy trial, 18,925 infants vaccinated with 7vPnC were followed for at least 5 years
after the end of the trial to compare the incidence of developmental delay, autistic spectrum
disorders, diabetes mellitus, Kawasaki disease, neutropenia, and reactive airways disease to the
controls that received MnCC vaccine. No statistically significant differences were found
between 7vPnC recipients and the control subjects. In addition, 7vPnC was found to be safe and
efficacious in 4340 pre-term and 1756 low birth weight infants in the pivotal efficacy trial
conducted at Northern California Kaiser Permanente.84,85