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Multicentre Study to Assess the Effect of Prophylactic Antipyretic Treatment on the Rate of Febrile Reactions Following Concomitant Administration of GSK Biologicals' 10-valent Pneumococcal Conjugate, Infanrix Hexa and Rotarix Vaccines

Trial Profile

Multicentre Study to Assess the Effect of Prophylactic Antipyretic Treatment on the Rate of Febrile Reactions Following Concomitant Administration of GSK Biologicals' 10-valent Pneumococcal Conjugate, Infanrix Hexa and Rotarix Vaccines

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2023

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At a glance

  • Drugs Pneumococcal 10-valent vaccine conjugate (Primary) ; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); Paracetamol; RIX 4414
  • Indications Diphtheria; Fever; Haemophilus infections; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Rotavirus infections; Tetanus
  • Focus Therapeutic Use
  • Acronyms 10PN-PD-DIT-010
  • Sponsors GlaxoSmithKline; GSK

Most Recent Events

  • 30 May 2013 Planned number of patients changed from 750 to 400 as reported by ClinicalTrials.gov.
  • 03 Dec 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
  • 17 Oct 2009 Results of primary and booster vaccination published in the Lancet.

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