4/24/2023 0 Comments Infanrix hexa 6 in 1 vaccine![]() ![]() 311,312 Although the manufacturing issue with the Merck HepB component was eventually resolved, Hexavac was not reintroduced. In 2005, reports appeared documenting a reduction in immunogenicity of the HepB component of Hexavac, 308–310 and the European licensing authority suspended its marketing authorization. Rates of local and systemic adverse events following administration of the hexavalent combined vaccines are comparable to those seen with other licensed DTaP-based vaccines. 166,167,189,190,191,195–198,212–220,293–307 Initial studies of both products showed good immunogenicity for their included antigens, producing seroprotection or seroconversion rates and GMTs similar to those seen with separate injections, except that Hib responses were somewhat lower than seen with separate administration of the Hib component (see Table 15.9). Both products have been extensively studied to characterize their immunogenicity, safety, and adaptability to a variety of primary and booster schedules. The Sanofi Pasteur product (Hexavac, now withdrawn see below) was a fully liquid combination of DTaP, IPV, and Hib components manufactured by Sanofi Pasteur plus HepB antigen manufactured by Merck. The GlaxoSmithKline product (Infanrix hexa) consists of GlaxoSmithKline's liquid DTaP3/HepB/IPV used to reconstitute its lyophilized PRP-T. Hexavalent (DTaP/HepB/IPV/Hib) vaccines from GlaxoSmithKline and Sanofi Pasteur have been licensed in Europe and elsewhere. 290 A consistency study with three lots of DTaP3/HepB mixed with three lots of PRP-T found Hib antibody levels of 0.15 µg/mL or greater in 100% and 1 µg/mL or greater in 85% of subjects the GMT was 4.05 µg/mL. Again, the children developed good antibody responses to PRP promptly after the booster immunization, demonstrating that the combination vaccine had successfully primed the immune system. 289 Zepp and colleagues 290 gave unconjugated PRP to children at 12 months of age who had been immunized at 3, 4, and 5 months of age with DTaP3/HepB//PRP-T. 194 The same PRP results were found in a German study in which infants were immunized at 3, 4, and 5 months of age mean PRP antibody levels were 1.2 and 5.5 µg/mL, respectively, for DTaP3/HepB//PRP-T and DTaP3/HepB + PRP-T. Children with low antibody responses to primary immunization had excellent responses when given booster doses. ![]() Pichichero and Passador 194 evaluated the DTaP/HepB//Hib combination versus separately administered vaccines and found antibody responses to be lower in the combined vaccine group for nearly all antigens and substantially lower for Hib (GMC, 1.2 vs 5.5 µg/mL proportion achieving 1.0 µg/mL or higher, 58% vs 88% for the combined and separate groups, respectively). Subjects with 7-month PRP antibody less than 1.0 µg/mL were administered a booster dose at 11 to 15 months of age postboost GMTs ranged from 3 to 5 µg/mL, depending on original study group, indicating that priming was achieved with all regimens. 193 No interference was seen in the antibody responses to the other components. For example, among children randomized at 2, 4, and 6 months of age to receive DTaP3/HepB//PRP-T, DTaP3/HepB + PRP-T, or DTaP3 + HepB + PRP-T, mean PRP antibody levels at 7 months of age were 1.6, 6.3, and 6.2 µg/mL, and the proportions achieving 1 µg/mL were 71%, 92%, and 90%, respectively. 193,194,289–292 As seen with most of the DTaP3//Hib and DTaP3/IPV//Hib combinations previously described, DTaP3//Hib-based combinations typically produce lower PRP antibody levels than are obtained with separate administration of the Hib component. Howe, in Plotkin's Vaccines (Seventh Edition), 2018 DTaP/HepB/Hib and DTaP/IPV/HepB/Hib CombinationsĪ number of studies have evaluated GlaxoSmithKline's DTaP3/HepB//PRP-T combination vaccine. This information paired with the small number of patients included leads to questionable generalizability for all Aboriginal infants at this time. Specific details regarding AEs were limited in the study document. Five SAEs were reported among the Aboriginal subjects, only a SAE of fever was deemed possibly related to the study vaccine as the onset occurred shortly after vaccination. Medically attended adverse events were higher in the Aboriginal group of infants compared to the non-Aboriginal group (23.2% versus 17%), but most of the events were not vaccine-related. rotavirus, pneumococcal conjugate vaccine, and meningococcal C conjugate) were permitted during the study period. Enrolled subjects received study vaccine at 2, 4, and 6 months of age. ![]() Jung, in Side Effects of Drugs Annual, 2016 Susceptibility Factor EthnicityĪ phase IV, open-label study of the combination DTaP-HBV-IPV/Hib (Infanrix Hexa®) vaccine was conducted in Canadian Aboriginal and non-Aboriginal infants aged 6–12 weeks.
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