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.

KEYWORDS:

• Safety
• immunogenicity
• DTaP-IPV-Hib-HepB Vaccine
• integrated analyses
• premature infants

Acknowledgments

We would like to thank Karyn Davis of Merck & Co., Inc., Kenilworth, NJ, USA for editorial support.

Disclosure of potential conflicts of interest

MB Wilck, J Xu, JE Stek, and AW Lee are employees of the Merck Sharp & Dohme, Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and may hold stock and/or stock options in the company.

Supplementary material

Supplemental data for this article can be accessed online at online at http://dx.doi.org/10.1080/21645515.2020.1756668.

Additional information

Funding

Funding for this research was provided by Merck & Co., Inc., Kenilworth, NJ, USA (sponsor). Although the sponsor formally reviewed a penultimate draft, the opinions expressed are those of the authors and may not necessarily reflect those of the sponsor. All co-authors approved the final version of the manuscript.