Русский
Evaluation of the safety and reactogenicity of the combined vaccine Pentaxim
Kharit S.M., Iozefovich O.V., Ruleva A.A., Fridman I.V., Kraynova T.I.
1Pediatric Research and Clinical Center for Infectious Diseases, Federal Biomedical Agency of Russia, Saint Petersburg, Russia; 2Saint Petersburg State Pediatric Medical University, Saint Petersburg, Russia; 3Directorate for Saint Petersburg, Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare, Saint Petersburg, Russia
Materials and methods. One-month clinical observation was made in 200 children (64 healthy individuals and 136 patients with different background diseases, who had been vaccinated with Pentaxim; and the incidence of postvaccination complications was also analyzed. For safety assessment, the investigators calculated the frequency of recorded postvaccination complications per Pentaxim doses used in the city in children aged 3 months to 4 years in the period 2009 to 2016 and analyzed the registration rate of Hib meningitis and cases of meningitis of unknown etiology as compared to the number of combined vaccine doses used in this period.
Results. The vaccination process was asymptomatic in 77% of the vaccinated; usual vaccination reactions were observed in 23% of cases (46 out of the 200 children), more frequently in children with a family history (38 (27.9%) of the 136 patients) than in the healthy children (8 (12.5%) of the 64 children); p < 0.05). Only 2 (1%) patients had strong reactions and a body temperature of above 38.6 оC. With the use of 334,804 vaccine doses, there was 1 case of Quincke’s edema, 1 case of febrile seizures, and 5 local allergic complications (1 case per 66,960 doses). According to the Directorate for Saint Petersburg, Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare, nearly 40% of the babies during the first year of life received combined vaccines with a Hib component in 2013–2014. The number of Hib meningitis cases decreased from 29 in 2009 to 5 in 2016; that of unspecified meningitis cases did from 27 to 3, respectively.
Conclusion. The vaccine is characterized by a low reactogenicity and a high safety profile, indicated for children with different health states, and can control the invasive forms of Haemophilus influenzae type b infection.
Literature
1. Report from the SAGE Working Group on Pertussis vaccines, 26–27 August 2014 meeting. Geneva, Switzerland. http://www.who.int/immunization/sage/meetings/2015/april/1_Pertussis_report_final.pdf?ua=1; accessed July 2015. 2. Weekly Epidemiological Record, Pertussis vaccines: WHO position paper 28 August 2015, №. 35. 2015; 90: 433–60. http://www.who.int/wer 3. de Celle M.D., Magpantay F.M.G., King A.A., Rohani P. The pertussis enigma: reconciling epidemiology, immunology and evolution. Proc. R. Soc. B 283: 20152309. http://dx.doi.org/10.1098/rspb.2015.2309 4. [State report ≪On the state sanitary and epidemiological wellbeing of the population in the Russian Federation in 2014≫. Federal service for supervision of consumer rights protection and human welfare; 2015]. http://rospotrebnadzor.ru/documents/details.php?ELEMENT_ID=3692 (In Russ.). 5 Jefferson T., Rudin M., DiPietrantonj C. Systematic review of the effects of pertussis vaccines in children. Vaccine 2003; 21: 2003–14. 6. Borba R.C.N., Vidal V. M., Moreira I. The re-emergency and persistence of vaccine preventable diseases Annals of the Brazilian Academy of Sciences 2015; 87(Suppl. 2): 1311–22. 7. Carlsson R., Trollfors B. Control of pertussis – lessons learnt from a 10-year surveillance programme in Sweden. Vaccine 2009; 27: 5709–18. 8. Okada K., Ohashi Y., Matsuo F., Uno S., Soh M., Nishima S. Effectiveness of an acellular pertussis vaccine in Japanese children during a non-epidemic period: a matched case-control study. Epidemiol. Infect. 2009; 137(1): 124–30. 9. Radke S., Petousis-Harris H., Watson D. et al. Age-specific effectiveness following each dose of acellular pertussis vaccine among infants and children in New Zealand. Vaccine 2017; 35:177–83. 10. Zhang L., Prietsch S., Axelsson I., Halperin S.A. Acellular vaccines for preventing whooping cough in children. The Cochrane database of systematic reviews 2014; 9: CD001478. 11. Offit P., Quarles J., Gerber M., Hackett C.J., Marcuse E.K., Kollman T.R., Bruce G., Landry S. Addressing parents’ concerns: Do multiple vaccines overwhelm or weaken the infant’s immune system? Pediatrics 2002; 109(1): 124–9. DOI: 10.1542/peds.109.1.124.
About the Autors
For correspondence: Susanna М. Kharit, е-mail: kharit-s@mail.ru
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