Received Dec 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 4 | — | — |
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | 4 | — | — |
administration of Hiberix 4 months before the recommended interval; Pediarix as the fourth dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 10-month-old male patient who received Hib (Hiberix) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included Hiberix (received first dose on 14-APR-2025), Hiberix (received second dose on 19-JUN-2025), Hiberix (received third dose on 21-AUG-2025), Pediarix (received first dose on 14-APR-2025), Pediarix (received second dose on 19-JUN-2025) and pediarix (received third dose on 21-AUG-2025). On 02-DEC-2025, the patient received the 4th dose of Hiberix and the 4th dose of Pediarix. On 02-DEC-2025, an unknown time after receiving Hiberix and not applicable after receiving Pediarix, the patient experienced drug dose administration interval too short (Verbatim: administration of Hiberix 4 months before the recommended interval) and extra dose administered (Verbatim: Pediarix as the fourth dose). The outcome of the drug dose administration interval too short and extra dose administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-DEC-2025 The patient had received Hiberix vaccine 4 months before the recommended interval, and Pediarix vaccine as the fourth dose. The patient was given the erroneous doses at 10 months. The batch number was not provided upon follow- up with the reporter.