Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | BH57H | — |
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Drug dose administration interval too long; Drug dose administration interval too long; 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 5-year-old male patient who received DTPa (Infanrix) (batch number BH57H, expiry date 07-JUL-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. Previously administered products included Infanrix (received first dose on 21-DEC-2021), PENTACEL (received first dose on 30-JUL-2020), PENTACEL (received second dose on 01-OCT-2020) and PENTACEL (received third dose on 10-DEC-2020). On 05-AUG-2025, the patient received the 3rd dose of Infanrix. On 18-JUL-2024, the patient received the 2nd dose of Infanrix. On 18-JUL-2024, not applicable after receiving Infanrix and an unknown time after receiving Infanrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On 05-AUG-2025, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). The outcome of the drug dose administration interval too long and drug dose administration interval too long 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: 15-AUG-2025 The reporter reported that patient was given an additional dose of diphtheria, tetanus, and pertussis (Infanrix) which led to lengthening of vaccination schedule. No further information was obtained in this call.