Received May 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | EF773 | — |
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | HZ9Z9 | — |
Shorter than recommended interval between 2nd and 3rd dose; Longer than recommended interval between 1st and 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 58-year-old male patient who received HAB (Twinrix) (batch number EF773, expiry date 09-SEP-2018) for prophylaxis. Co-suspect products included HAB (Twinrix) (batch number EF773, expiry date 09-SEP-2018), (batch number EF77N, expiry date 09-SEP-2018) and (batch number HZ9Z9, expiry date 03-MAR-2017) for prophylaxis. Previously administered products included Twinrix (received 1st dose twinrix on 1st January 2015 with batch number HZ9Z9 and expiry date 3rd March 2017). In APR-2017, the patient received the 3rd dose of Twinrix. On 01-JAN-2017, the patient received the 2nd dose of Twinrix. On 01-JAN-2017, not applicable after receiving Twinrix, 731 days after receiving Twinrix and an unknown time after starting Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended interval between 1st and 2nd dose). In APR-2017, the patient experienced drug dose administration interval too short (Verbatim: Shorter than recommended interval between 2nd and 3rd dose). The outcome of the drug dose administration interval too short 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: 05-MAY-2025 The physician called to request data regarding the possibility of a schedule variation being used. The patient had received the first dose in January 2015, with lot number HZ9Z9 and expiration date 03rd March 2017. The second dose was administered in January 2017, with lot number EF773 and expiration date 09th September 2018, and the third dose was given in April 2017, with the same lot number EF773 and expiration date 09th September 2018. The physician had only inquired about the shorter than recommended interval between the second and third doses but did not ask about the longer than recommended interval between the first two doses. The interval between the second and third dose was shorter than recommended, which led to Drug dose administration interval too short. The interval between the first and second dose was longer than recommended, which led to Drug dose administration interval too long.