Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
late 3rd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included Pediarix (Patient received 1 st dose on 03-DEC-2022) and Pediarix (Patient received 2 nd dose on 17-FEB-2023). On 28-SEP-2023, the patient received the 3rd dose of Pediarix. On 28-SEP-2023, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: late 3rd dose). The outcome of the drug dose administration interval too long was 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: 14-AUG-2025 Nurse reports patient received Pediarix at 2, 4, and 12 months of age and Infanrix at 15 months of age. The patient received 3rd dose of Pediarix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 4th DTaP dose was Infanrix on 27-DEC-2023.