6,972
Views
16
CrossRef citations to date
0
Altmetric
Research Papers

Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: An open-label, randomized, controlled, non-inferiority trial

, , , , , , , , , , , , , , & show all
Pages 649-660 | Received 09 Jun 2016, Accepted 08 Aug 2016, Published online: 22 Feb 2017

References

  • Deceuninck G, De Serres G, Boulianne N, Lefebvre B, De Wals P. Effectiveness of three pneumococcal conjugate vaccines to prevent invasive pneumococcal disease in Quebec, Canada. Vaccine 2015; 33:2684-9; PMID:25887086; http://dx.doi.org/10.1016/j.vaccine.2015.04.005
  • Domingues CM, Verani JR, Montenegro Renoiner EI, de Cunto Brandileone MC, Flannery B, de Oliveira LH, Santos JB, de Moraes JC. Effectiveness of ten-valent pneumococcal conjugate vaccine against invasive pneumococcal disease in Brazil: a matched case-control study. Lancet Respir Med 2014; 2:464-71; PMID:24726406; http://dx.doi.org/10.1016/S2213-2600(14)70060-8
  • Palmu AA, Jokinen J, Borys D, Nieminen H, Ruokokoski E, Siira L, Puumalainen T, Lommel P, Hezareh M, Moreira M, et al. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet 2013; 381:214-22; PMID:23158882; http://dx.doi.org/10.1016/S0140-6736(12)61854-6
  • Tregnaghi MW, Saez-Llorens X, Lopez P, Abate H, Smith E, Posleman A, Calvo A, Wong D, Cortes-Barbosa C, Ceballos A, et al. Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial. PLoS Med 2014; 11:e1001657; PMID:24892763; http://dx.doi.org/10.1371/journal.pmed.1001657
  • Knuf M, Habermehl P, Cimino C, Petersen G, Schmitt HJ. Immunogenicity, reactogenicity and safety of a 7-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a DTPa-HBV-IPV/Hib combination vaccine in healthy infants. Vaccine 2006; 24:4727-36; PMID:16616973; http://dx.doi.org/10.1016/j.vaccine.2006.03.032
  • Olivier C, Belohradsky BH, Stojanov S, Bonnet E, Petersen G, Liese JG. Immunogenicity, reactogenicity, and safety of a seven-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a fully liquid DTPa-IPV-HBV-Hib combination vaccine in healthy infants. Vaccine 2008; 26:3142-52; PMID:18502545; http://dx.doi.org/10.1016/j.vaccine.2007.11.096
  • Stockwell MS, Broder K, LaRussa P, Lewis P, Fernandez N, Sharma D, Barrett A, Sosa J, Vellozzi C. Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine. JAMA Pediatr 2014; 168:211-9; PMID:24395025; http://dx.doi.org/10.1001/jamapediatrics.2013.4469
  • Taddio A, Manley J, Potash L, Ipp M, Sgro M, Shah V. Routine immunization practices: use of topical anesthetics and oral analgesics. Pediatrics 2007; 120:e637-43; PMID:17766503; http://dx.doi.org/10.1542/peds.2006-3351
  • Prymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet 2009; 374:1339-50; PMID:19837254; http://dx.doi.org/10.1016/S0140-6736(09)61208-3
  • Prymula R, Habib A, Francois N, Borys D, Schuerman L. Immunological memory and nasopharyngeal carriage in 4-year-old children previously primed and boosted with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) with or without concomitant prophylactic paracetamol. Vaccine 2013; 31:2080-8; PMID:23391599; http://dx.doi.org/10.1016/j.vaccine.2013.01.044
  • Wysocki J, Center KJ, Brzostek J, Majda-Stanislawska E, Giardina P, Sundaraiyer V, Patterson S, Gruber WC, Scott D, Gurtman A. Does use of prophylactic antipyrectics affect immune response to vaccination in infants?. ISPPD. Hyderabad, India, 2014.
  • Prymula R, Esposito S, Zuccotti GV, Xie F, Toneatto D, Kohl I, Dull PM. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I): Efects of prophylactic paracetamol on immunogenicity and reactogenicity of routine infant vaccines and 4CMenB. Hum Vaccin Immunother 2014; 10:1993-2004; http://dx.doi.org/10.4161/hv.28666
  • Das RR, Panigrahi I, Naik SS. The effect of prophylactic antipyretic administration on post-vaccination adverse reactions and antibody response in children: a systematic review. PLoS One 2014; 9:e106629; PMID:25180516; http://dx.doi.org/10.1371/journal.pone.0106629
  • CHMP. Guideline on the Choice of the Non-inferiority Margin. 2005.
  • Leung AK, Robson WL. Febrile seizures. J Pediatr Health Care 2007; 21:250-5; PMID:17606162; http://dx.doi.org/10.1016/j.pedhc.2006.10.006
  • Bancos S, Bernard MP, Topham DJ, Phipps RP. Ibuprofen and other widely used non-steroidal anti-inflammatory drugs inhibit antibody production in human cells. Cell Immunol 2009; 258:18-28; PMID:19345936; http://dx.doi.org/10.1016/j.cellimm.2009.03.007
  • Tucci J, Bandiera E, Darwiche R, Medos Z, Nashed R, Trinh D. Paracetamol and Ibuprofen for Paediatric Pain and Fever. Journal of Pharmacy Practice and Research 2009; 39:223-5; http://dx.doi.org/10.1002/j.2055-2335.2009.tb00458.x
  • Jozwiak-Bebenista M, Nowak JZ. Paracetamol: mechanism of action, applications and safety concern. Acta Pol Pharm 2014; 71:11-23; PMID:24779190
  • Kis B, Snipes JA, Busija DW. Acetaminophen and the cyclooxygenase-3 puzzle: sorting out facts, fictions, and uncertainties. J Pharmacol Exp Ther 2005; 315:1-7; PMID:15879007; http://dx.doi.org/10.1124/jpet.105.085431
  • Purssell E. Cyclooxygenase inhibitors inhibit antibody response through interference with MAPK/ERK pathways and BLIMP-1 inhibition. Med Hypotheses 2014; 83:372-7; PMID:25012778; http://dx.doi.org/10.1016/j.mehy.2014.06.015
  • Prokopowicz ZM, Arce F, Biedron R, Chiang CL, Ciszek M, Katz DR, Nowakowska M, Zapotoczny S, Marcinkiewicz J, Chain BM. Hypochlorous acid: a natural adjuvant that facilitates antigen processing, cross-priming, and the induction of adaptive immunity. J Immunol 2010; 184:824-35; PMID:20018624; http://dx.doi.org/10.4049/jimmunol.0902606
  • Parepally JM, Mandula H, Smith QR. Brain uptake of nonsteroidal anti-inflammatory drugs: ibuprofen, flurbiprofen, and indomethacin. Pharm Res 2006; 23:873-81; PMID:16715377; http://dx.doi.org/10.1007/s11095-006-9905-5
  • Smith HS. Potential analgesic mechanisms of acetaminophen. Pain Physician 2009; 12:269-80; PMID:19165309
  • Ottani A, Leone S, Sandrini M, Ferrari A, Bertolini A. The analgesic activity of paracetamol is prevented by the blockade of cannabinoid CB1 receptors. Eur J Pharmacol 2006; 531:280-1; PMID:16438952; http://dx.doi.org/10.1016/j.ejphar.2005.12.015
  • Sinning C, Watzer B, Coste O, Nusing RM, Ott I, Ligresti A, Di Marzo V, Imming P. New analgesics synthetically derived from the paracetamol metabolite N-(4-hydroxyphenyl)-(5Z,8Z,11Z,14Z)-icosatetra-5,8,11,14-enamide. J Med Chem 2008; 51:7800-5; PMID:19053765; http://dx.doi.org/10.1021/jm800807k
  • Cencioni MT, Chiurchiu V, Catanzaro G, Borsellino G, Bernardi G, Battistini L, Maccarrone M. Anandamide suppresses proliferation and cytokine release from primary human T-lymphocytes mainly via CB2 receptors. PLoS One 2010; 5:e8688; PMID:20098669; http://dx.doi.org/10.1371/journal.pone.0008688
  • Aksoy E, Goldman M, Willems F. Protein kinase C epsilon: a new target to control inflammation and immune-mediated disorders. Int J Biochem Cell Biol 2004; 36:183-8; PMID:14643884; http://dx.doi.org/10.1016/S1357-2725(03)00210-3
  • Vellani V, Franchi S, Prandini M, Moretti S, Castelli M, Giacomoni C, Sacerdote P. Effects of NSAIDs and paracetamol (acetaminophen) on protein kinase C epsilon translocation and on substance P synthesis and release in cultured sensory neurons. J Pain Res 2013; 6:111-20; PMID:23429763; http://dx.doi.org/10.2147/JPR.S36916
  • Rose MA, Juergens C, Schmoele-Thoma B, Gruber WC, Baker S, Zielen S. An open-label randomized clinical trial of prophylactic paracetamol coadministered with 7-valent pneumococcal conjugate vaccine and hexavalent diphtheria toxoid, tetanus toxoid, 3-component acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine. BMC Pediatr 2013; 13:98; PMID:23786774; http://dx.doi.org/10.1186/1471-2431-13-98
  • Manley J, Taddio A. Acetaminophen and ibuprofen for prevention of adverse reactions associated with childhood immunization. Ann Pharmacother 2007; 41:1227-32; PMID:17519301; http://dx.doi.org/10.1345/aph.1H647
  • Autret E, Reboul-Marty J, Henry-Launois B, Laborde C, Courcier S, Goehrs JM, Languillat G, Launois R. Evaluation of ibuprofen versus aspirin and paracetamol on efficacy and comfort in children with fever. Eur J Clin Pharmacol 1997; 51:367-71; PMID:9049576; http://dx.doi.org/10.1007/s002280050215
  • Perrott DA, Piira T, Goodenough B, Champion GD. Efficacy and safety of acetaminophen vs ibuprofen for treating children's pain or fever: a meta-analysis. Arch Pediatr Adolesc Med 2004; 158:521-6; PMID:15184213; http://dx.doi.org/10.1001/archpedi.158.6.521
  • Sullivan JE, Farrar HC. Fever and antipyretic use in children. Pediatrics 2011; 127:580-7; PMID:21357332; http://dx.doi.org/10.1542/peds.2010-3852
  • Lehman E, Romano J. Generalizations of the Familywise Error Rate. The Annuals of Statistics 2005; 33:1138-54; http://dx.doi.org/10.1214/009053605000000084