Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | AC21B115CB | — |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
tested for HepB titers and the test showed she was not vaccinated; The dates of administration were the following 12/Jul/2007, 14/Sep/2007, 2/Nov/2007; This non-serious case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number AC21B115CB) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis. On 02-NOV-2007, the patient received the 3rd dose of Pediarix. On 14-SEP-2007, the patient received the 2nd dose of Pediarix. On 12-JUL-2007, the patient received the 1st dose of Pediarix. On 02-NOV-2007, an unknown time after receiving Pediarix, not applicable after receiving Pediarix and Pediarix and not applicable after receiving Pediarix and Pediarix, the patient experienced drug dose administration interval too short (Verbatim: The dates of administration were the following 12/Jul/2007, 14/Sep/2007, 2/Nov/2007). On an unknown date, the patient experienced therapy non-responder (Verbatim: tested for HepB titers and the test showed she was not vaccinated). The outcome of the therapy non-responder and drug dose administration interval too short 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: 02-JUN-2025 The patient received Pediarix when she was her last shot, it was given early, she was told that she was not vaccinated correctly, which led shortening of vaccination schedule. The reporter mentioned that they had tested for Hepatitis B titers, and the test showed she was not vaccinated, which led therapy non responder.