Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

Phase 4 Completed 908 enrolled Pfizer

RandomizedParallel-groupOpen-labelPrevention

Summary

The purposes of this study are assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months of age when medications to prevent fever are given on the same day as the vaccination. Also to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who receive medications to prevent fever on the day of vaccination.

Timeline

Start: 2011-08
Primary completion: 2013-01
Completion: 2013-01

Publications

Wysocki J, Center KJ, Brzostek J, Majda-Stanislawska E, Szymanski H, Szenborn L, Czajka H, Hasiec B, Dziduch J, Jackowska T, Witor A, Kopinska E, Konior R, Giardina PC, Sundaraiyer V, Patterson S, Gruber WC, Scott DA, Gurtman A. A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations. Vaccine. 2017 Apr 4;35(15):1926-1935. doi: 10.1016/j.vaccine.2017.02.035. Epub 2017 Mar 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	15 mg/kg	Oral
Subject	Ibuprofen	Small molecule	10 mg/kg	Oral
Subject	Infanrix hexa	Vaccine	—	Intramuscular
Subject	Prevnar 13	Vaccine	—	Intramuscular

Indications

No indication recorded.