PMID- 28429115 OWN - NLM STAT- MEDLINE DCOM- 20180301 LR - 20181113 IS - 1432-1076 (Electronic) IS - 0340-6199 (Linking) VI - 176 IP - 6 DP - 2017 Jun TI - Comparison of the tolerability of newly introduced childhood vaccines in the Netherlands. PG - 757-768 LID - 10.1007/s00431-017-2901-4 [doi] AB - In 2011, the 7-valent conjugated pneumococcal vaccine (PCV7) was replaced by the 10-valent vaccine (PCV10) and universal hepatitis B vaccination has been introduced in the Netherlands. A questionnaire study was conducted to assess the tolerability of DTaP-IPV-Hib + PCV7 (PCV7-cohort), DTaP-IPV-Hib + PCV10 (PCV10-cohort), and DTaP-IPV-Hib-HepB + PCV10 (HepB-cohort). Parents were asked to report in questionnaires local reactions and systemic adverse events (AEs) before and after vaccination of their infant at 2, 3, 4, and 11 months of age. For 29.0 and 29.4% infants of the PCV7-cohort, at least one local reaction was reported in the week after the first dose of DTaP-IPV (left leg) and PCV-7 vaccination (right leg). Significantly more infants from the PCV10-cohort (45.1%, p < 0.001 and 44.6%, p < 0.001) and HepB-cohort (42.6%, p < 0.001 and 41.9%, p < 0.001) reported at least one local reaction. This effect was less pronounced after the successive doses. Most of the infants experienced at least one systemic AE, and after dose 4, this was higher for infants in the PCV10-cohort (65.9%, p = 0.047) and HepB-cohort (70.6%, p = 0.000) compared to the PCV7-cohort (62.3%). CONCLUSION: Addition of antigens to a vaccine resulted in a higher reactogenicity, but the AEs were in general mild and transient. What is Known: * Assessment of adverse events is crucial for achieving the highest safety in immunization programs, in order to inform public health actions and maintain public confidence in immunization programs. What is New: * Newly introduced vaccines DTaP-IPV-Hib-HepB and PCV10 are generally safe and well tolerated in infants. * These results are useful for information purposes and for monitoring variations in rates of AEs in the general population or in the target group over time. FAU - Kemmeren, Jeanet M AU - Kemmeren JM AD - Center for Infectious Disease Control, National Institute for Public Health and the Environment, P.O. Box 1, 3720 BA, Bilthoven, The Netherlands. jeanet.kemmeren@rivm.nl. FAU - van der Maas, Nicoline At AU - van der Maas NA AD - Center for Infectious Disease Control, National Institute for Public Health and the Environment, P.O. Box 1, 3720 BA, Bilthoven, The Netherlands. FAU - de Melker, Hester E AU - de Melker HE AD - Center for Infectious Disease Control, National Institute for Public Health and the Environment, P.O. Box 1, 3720 BA, Bilthoven, The Netherlands. LA - eng PT - Comparative Study PT - Journal Article DEP - 20170420 PL - Germany TA - Eur J Pediatr JT - European journal of pediatrics JID - 7603873 RN - 0 (10-valent pneumococcal conjugate vaccine) RN - 0 (Diphtheria-Tetanus-Pertussis Vaccine) RN - 0 (Haemophilus Vaccines) RN - 0 (Hepatitis B Vaccines) RN - 0 (Pneumococcal Vaccines) RN - 0 (Poliovirus Vaccine, Inactivated) RN - 0 (Vaccines, Conjugate) RN - 0 (diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine) SB - IM MH - Diphtheria-Tetanus-Pertussis Vaccine/*adverse effects MH - Female MH - Haemophilus Vaccines/*adverse effects MH - Health Care Surveys MH - Hepatitis B Vaccines/*adverse effects MH - Humans MH - Immunization Schedule MH - Infant MH - Male MH - Models, Statistical MH - Netherlands MH - Pneumococcal Vaccines/*adverse effects MH - Poliovirus Vaccine, Inactivated/*adverse effects MH - Vaccines, Conjugate/adverse effects OTO - NOTNLM OT - Hexavalent vaccine OT - Infants OT - Pentavalent vaccine OT - Pneumococcal vaccine OT - Reactogenicity OT - Tolerability EDAT- 2017/04/22 06:00 MHDA- 2018/03/02 06:00 CRDT- 2017/04/22 06:00 PHST- 2016/10/25 00:00 [received] PHST- 2017/03/24 00:00 [accepted] PHST- 2017/03/22 00:00 [revised] PHST- 2017/04/22 06:00 [pubmed] PHST- 2018/03/02 06:00 [medline] PHST- 2017/04/22 06:00 [entrez] AID - 10.1007/s00431-017-2901-4 [pii] AID - 10.1007/s00431-017-2901-4 [doi] PST - ppublish SO - Eur J Pediatr. 2017 Jun;176(6):757-768. doi: 10.1007/s00431-017-2901-4. Epub 2017 Apr 20.