Antibody persistence following administration of a hexavalent DTwP-IPV-HB-PRP∼T vaccine versus separate DTwP-HB-PRP∼T and IPV vaccines at 12–24 months of age and safety and immunogenicity of a booster dose of DTwP-IPV-HB-PRP∼T in healthy infants in India

Lot-to-lot consistency of a hexavalent DTwP-IPV-HB-PRP∼T vaccine and non-inferiority to separate DTwP-HB-PRP∼T and IPV antigen-matching vaccines at 6–8, 10–12, and 14–16 weeks of age co-administered with oral rotavirus vaccine in healthy infants in India: A multi-center, randomized, controlled study

“…Despite isolated differences, such as higher anti-polio GMTs in the DTwP-IPV-HB-PRP∼T group and higher anti-FHA GMC in the DTwP-HB-PRP∼T and IPV group, no differences between the two groups were considered to be clinically important and such isolated differences were expected for this type of vaccine [22] , [23] , [24] . These data are comparable to previous data for the new hexavalent vaccine [6] , [7] as well as other vaccines of this type [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] suggesting no interaction due to the co-administration with rotavirus vaccine. In particular, the high anti-polio antibody titers for the DTwP-IPV-HB-PRP∼T vaccine, which were almost twice as high as for standalone IPV and expected due to the adjuvant effect of aluminum contained in the vaccine [33] , [34] , [35] , [36] and consistent with previous studies, ensure alignment with the polio endgame strategy and withdrawal of OPV [3] , [37] .…”

“…One participant died of SIDS before the third dose of DTwP-IPV-HB-PRP∼T was due, and this was not considered to be related to vaccine administration. The DTwP-IPV-HB-PRP∼T safety profile was comparable to previous studies with this vaccine [6] , [7] and its wP-antigen matching predecessor [48] , [49] , [50] .…”

“…Anti-D (IU/mL), anti-T (IU/mL), anti-PT (EU/mL), anti-FHA (EU/mL), anti-PRN (EU/mL), anti-FIM (EU/mL) antibody concentrations were measured by a multiplexed chemiluminescence assay using the Meso Scale Discovery platform (DTP-ECL) [7] , [8] . For the B. pertussis antigens, results were expressed in EU calibrated against the US reference pertussis antiserum (human) lot 3 and lot 4 for IgG antibodies [9] , [10] .…”

“…Ideally, at least three lots with the same formulation should be used, manufactured at full production scale, and the study should be designed and analyzed as an equivalence trial with pre-defined criteria to conclude comparability [4] , [5] . The new DTwP-IPV-HB-PRP∼T vaccine has been evaluated as safe and immunogenic in randomized, controlled, early phase clinical studies [6] , [7] . This study was conducted to establish that the hexavalent vaccine was safe and immunologically non-inferior to the administration of the licensed pentavalent and injectable polio vaccines.…”

Immunogenicity and Safety of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T, bOPV, and IPV Vaccines Administered at 2, 4, 6 Months of Age Concomitantly With Rotavirus and Pneumococcal Conjugate Vaccines in Healthy Infants in Thailand

“…Previous studies have shown good vaccine safety, strong immunogenicity and lot-to-lot consistency for the DTwP-IPV-HB-PRP~T vaccine following primary vaccination at 6–8, 10–12 and 10–14 weeks, and a booster at 12–24 months of age. 3–5 A full list of abbreviations used within this article can be found in Table, Supplemental Digital Content 1, http://links.lww.com/INF/F71.…”