title: A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations.
abstract: Prophylactic antipyretic use during pediatric vaccination is common. This study assessed whether paracetamol or ibuprofen prophylaxis interfere with immune responses to the 13-valent pneumococcal conjugate vaccine (PCV13) given concomitantly with the combined DTaP/HBV/IPV/Hib vaccine.
  
  
  
  Subjects received prophylactic paracetamol or ibuprofen at 0, 6-8, and 12-16 h after vaccination, or 6-8 and 12-16 h after vaccination at 2, 3, 4, and 12months of age. At 5 and 13months, immune responses were evaluated versus responses in controls who received no prophylaxis.
  
  
  
  After the infant series, paracetamol recipients had lower levels of circulating serotype-specific pneumococcal anticapsular immunoglobulin G than controls, reaching significance (P<0.0125) for 5 serotypes (serotypes 3, 4, 5, 6B, and 23F) when paracetamol was started at vaccination. Opsonophagocytic activity assay (OPA) results were similar between groups. Ibuprofen did not affect pneumococcal responses, but significantly (P<0.0125) reduced antibody responses to pertussis filamentous hemagglutinin and tetanus antigens after the infant series when started at vaccination. No differences were observed for any group after the toddler dose.
  
  
  
  Prophylactic antipyretics affect immune responses to vaccines; these effects vary depending on the vaccine, antipyretic agent, and time of administration. In infants, paracetamol may interfere with immune responses to pneumococcal antigens, and ibuprofen may reduce responses to pertussis and tetanus antigens. The use of antipyretics for fever prophylaxis during infant vaccination merits careful consideration. ClinicalTrials.gov identifier: NCT01392378https://clinicaltrials.gov/ct2/show/NCT01392378?term=NCT01392378&rank=1.
authors.affiliation: Department of Preventive Medicine, Poznań University of Medical Sciences, ul. Smoluchowskiego 11, 60-179 Poznań, Poland. Electronic address: jawysocki@pro.onet.pl.
authors.forename: Jacek
authors.initials: J
authors.lastname: Wysocki
authors.affiliation: Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: kimberly.center@pfizer.com.
authors.forename: Kimberly J
authors.initials: KJ
authors.lastname: Center
authors.affiliation: Zespol Opieki Zdrowotnej w Debicy, Krakowska 91, 39-200 Debica, Poland. Electronic address: jerzy_br@poczta.onet.pl.
authors.forename: Jerzy
authors.initials: J
authors.lastname: Brzostek
authors.affiliation: Department of Pediatric Infectious Diseases, Medical University of Lodz, Al. Kościuszki 4, 90-419 Lodz, Poland. Electronic address: emajda@lodz.home.pl.
authors.forename: Ewa
authors.initials: E
authors.lastname: Majda-Stanislawska
authors.affiliation: NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak, Trzebnicka 37, 55-120 Oborniki Slaskie, Poland. Electronic address: henryktomasz@poczta.onet.pl.
authors.forename: Henryk
authors.initials: H
authors.lastname: Szymanski
authors.affiliation: Department of Pediatric Infectious Diseases, Wroclaw Medical University, ul. Chałubińskiego 2-2a, 50-368 Wroclaw, Poland. Electronic address: leszek.szenborn@am.wroc.pl.
authors.forename: Leszek
authors.initials: L
authors.lastname: Szenborn
authors.affiliation: Indywidualna Specjalistyczna Praktyka Lekarska, Braci Kiemliczow 14, 30-389 Krakow, Poland. Electronic address: hanna.czajka@onet.pl.
authors.forename: Hanna
authors.initials: H
authors.lastname: Czajka
authors.affiliation: NZOZ Praktyka Lekarza Rodzinnego, ul. Weteranów 46, 20-044 Lublin, Poland. Electronic address: bhasiec@wp.pl.
authors.forename: Barbara
authors.initials: B
authors.lastname: Hasiec
authors.affiliation: SPZOZ Lubartow Oddzial Pediatryczny, ul. Cicha 14, 21-100 Lubartow, Poland. Electronic address: jurekad@tlen.pl.
authors.forename: Jerzy
authors.initials: J
authors.lastname: Dziduch
authors.affiliation: Department of Pediatrics, Medical Center of Postgraduate Education, ul. Marymoncka 99/103, 01-813 Warsaw, Poland. Electronic address: tjackowska@cmkp.edu.pl.
authors.forename: Teresa
authors.initials: T
authors.lastname: Jackowska
authors.affiliation: NZLA Michalkowice Jaroszy i Partnerzy, Kościelna 32, 41-103 Siemianowice, Slaskie, Poland. Electronic address: adamanita@interia.pl.
authors.forename: Anita
authors.initials: A
authors.lastname: Witor
authors.affiliation: Physicians Practice Group Family Specialist Outpatient Clinic, Szosa Chelminska 54B/4, 87-100 Torun, Poland. Electronic address: ela.kopinska@gmail.com.
authors.forename: Elżbieta
authors.initials: E
authors.lastname: Kopińska
authors.affiliation: NZOZ "Praktimed" sp. z o.o., Strzelców 15, 31-422 Krakow, Poland. Electronic address: rkonior@szpitaljp2.krakow.pl.
authors.forename: Ryszard
authors.initials: R
authors.lastname: Konior
authors.affiliation: Pfizer Vaccine Research, 401 N. Middletown Rd, Pearl River, NY 10965, USA. Electronic address: peter.giardina@pfizer.com.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Giardina
authors.affiliation: inVentiv Health Clinical, LLC, 504 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: Vani.Sundaraiyer@inventivhealth.com.
authors.forename: Vani
authors.initials: V
authors.lastname: Sundaraiyer
authors.affiliation: Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: Scott.Patterson@pfizer.com.
authors.forename: Scott
authors.initials: S
authors.lastname: Patterson
authors.affiliation: Pfizer Vaccine Research, 401 N. Middletown Rd, Pearl River, NY 10965, USA. Electronic address: Bill.Gruber@pfizer.com.
authors.forename: William C
authors.initials: WC
authors.lastname: Gruber
authors.affiliation: Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: dan.scott@pfizer.com.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Scott
authors.affiliation: Pfizer Vaccine Research, 401 N. Middletown Rd, Pearl River, NY 10965, USA. Electronic address: Alejandra.Gurtman@pfizer.com.
authors.forename: Alejandra
authors.initials: A
authors.lastname: Gurtman
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage*; D000907:Antibodies, Bacterial / Q000097:blood; D058633:Antipyretics / Q000008:administration & dosage*; D018890:Chemoprevention / Q000379:methods*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects; D004347:Drug Interactions; D005260:Female; D005334:Fever / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000009:adverse effects; D017325:Hepatitis B Vaccines / Q000009:adverse effects; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D007223:Infant; D008297:Male; D009895:Opsonin Proteins / Q000097:blood; D010587:Phagocytosis; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects; D017778:Vaccines, Combined / Q000009:adverse effects
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D058633:Antipyretics; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D009895:Opsonin Proteins; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; C541235:diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; D000082:Acetaminophen; D007052:Ibuprofen
keywords: Antipyretic; Ibuprofen; Immune response; Infant; Paracetamol; Pneumococcal conjugate vaccine