Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants

Abstract

Background: Immune immaturity may put premature infants at increased risk for infections. DTaP-IPV-Hib-HepB vaccine (Vaxelis™), a hexavalent vaccine studied in >6,800 children, has acceptable safety and immunogenicity profiles generally similar to control vaccines. Here we evaluate safety and immunogenicity of DTaP-IPV-Hib-HepB vaccine in premature infants. Methods: Premature infants were identified using prior medical conditions terms "premature baby/ delivery" and/or "low birth weight baby". Immunogenicity and safety data were summarized across one Phase II and four Phase III randomized, active-comparator-controlled clinical trials (Protocol 004 in Canada [Control: PENTACEL™]; Protocols 005 and 006 in the US [Control: PENTACEL™]; and Protocols 007 and 008 in the EU [Control: INFANRIX™ hexa]) and one Phase III clinical trial in the UK (PRI01C); no formal statistical comparisons were performed. Results: Overall, 160 infants were considered premature (DTaP-IPV-Hib-HepB = 111 Control = 49). The incidence of adverse events (AEs) for DTaP-IPV-Hib-HepB was comparable between overall and premature populations for all AEs days 1-15 postvaccination (Overall = 96.3%; Premature = 97.3%;), solicited injection-site AEs days 1-5 postvaccination (Overall = 84.1%; Premature = 75.5%), and solicited systemic AEs days 1-5 postvaccination (Overall = 93.7%; Premature = 94.5%).A high percentage of premature infants mounted protective immune responses to antigens contained in DTaP-IPV-Hib-HepB vaccine. Response rates in preterm infants for all antigens (80-99%) were in a similar range to all infants (80-99%) for both DTaP-IPV-Hib-HepB and control vaccines. Conclusions: DTaP-IPV-Hib-HepB vaccine has a low incidence of AEs, an acceptable safety profile, and elicited satisfactory immune responses in premature infants comparable to the overall study population. These findings support vaccination with DTaP-IPV-Hib-HepB vaccine in healthy premature infants.

Safety of Hepatitis B Vaccines (Monovalent or as Part of Combination) in Preterm Infants: A Systematic Review

“…In the 333 infants studied overall, this appeared not to be the case, as the occurrence of AEFIs was not significantly different between these groups. Similarly, this observation was also found in one study that reported on whether preterm birth predisposes infants to a higher risk of AEFIs when compared to term infants [ 32 ].…”

“…However, other studies reported somewhat different findings. For example, 9 other studies published AEFI rates greater than 10% in a total number of 1833 babies ( Table 1 and Table 3 ), with one study observing non-cardiorespiratory AEFIs in up to 96% of vaccination episodes [ 32 ]. However, in each of these 15 studies, the reported AEFIs were mostly minor, including low-grade fever, local reactions such as rashes, local pain, erythema and swelling, and short-lived episodes of apnoea and bradycardia, which did not require escalation of support (total of 5488 babies; Table 1 , Table 2 and Table 3 ).…”

“…SAEs were reported to be associated with the vaccines containing the hepatitis B antigen in 6 studies [ 20 , 22 , 24 , 26 , 27 , 32 ] with a total number of 1051 infants ( Table 1 and Table 3 , SAEs highlighted in bold). Such SAEs comprised apnoea/bradycardia/desaturations (recurrent or at least requiring stimulation or intermittent positive pressure ventilation), which occurred in 8% to 18% of preterm infants following a multi-antigen vaccine containing hepatitis B.…”

“…Three studies explored the question of whether preterm birth predisposes infants to a higher risk of AEFIs in response to vaccinations ([ 19 , 32 , 34 ]; Table 1 and Table 3 ). In the 333 infants studied overall, this appeared not to be the case, as the occurrence of AEFIs was not significantly different between these groups.…”

Analysis of risk factor for pneumonia in children less than five years in Makassar

“…Antibody persistence for diphtheria, tetanus, hepatitis B, and Hib in children was found after complete basic immunization with DPT-HB-Hib at 3 months, 5 months, and 11 to 12 months. [ 16 ] The rate of pertussis vaccine response was 82.5% at anti-pertussis concentrations ≥40 (1/dL) with a significance value of P = 0.038. [ 17 ]…”