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

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

Outcome

Missed primary endpoint

registry 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily vs 13vPnC + INFANRIX Hexa; p = 0.0012; GMC Ratio 0.73 (95% CI 0.62 to 0.86) NCT01392378 ↗

paper paracetamol recipients had lower levels of circulating serotype-specific pneumococcal anticapsular immunoglobulin G than controls PMID 28262330 ↗

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	13-valent pneumococcal conjugate vaccine	Vaccine	—	Intramuscular
Subject	Acetaminophen	Small molecule	15 mg/kg	Oral
Subject	Ibuprofen	Small molecule	10 mg/kg	Oral
Subject	Infanrix hexa	Vaccine	—	Intramuscular

Indications

No indication recorded.