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# FDA OKs Expanded Age Indication for GSK’s Hiberix
- URL: https://www.fdaweb.com/fda-oks-expanded-age-indication-for-gsks-hiberix/
- Published: 2016-01-15T12:00:00.000Z
- Updated: 2026-09-15T02:28:01.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5134448

> FDA has approved an expanded age indication for GlaxoSmithKline’s Hiberix \[Haemophilus b conjugate vaccine (tetanus toxoid conjugate)\]. The vaccine is now indicated for immunizing children aged six weeks through four years against invasive disease caused by *Haemophilus influenzae* type b (Hib). Approvals was based on data showing immune responses in children using serological endpoints that predict protection from invasive disease due to Hib, according to the company. “Across clinical trials, common solicited adverse events (20%) were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness,” it says.