PMID- 32750261
OWN - NLM
STAT- MEDLINE
DCOM- 20210621
LR  - 20210621
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 17
IP  - 1
DP  - 2021 Jan 2
TI  - Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis) 
      in premature infants.
PG  - 191-196
LID - 10.1080/21645515.2020.1756668 [doi]
AB  - 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.
FAU - Wilck, Marissa B
AU  - Wilck MB
AUID- ORCID: 0000-0002-6890-1118
AD  - Merck & Co., Inc ., Kenilworth, NJ, USA.
FAU - Xu, Z Jin
AU  - Xu ZJ
AD  - Merck & Co., Inc ., Kenilworth, NJ, USA.
FAU - Stek, Jon E
AU  - Stek JE
AUID- ORCID: 0000-0001-7521-874X
AD  - Merck & Co., Inc ., Kenilworth, NJ, USA.
FAU - Lee, Andrew W
AU  - Lee AW
AD  - Merck & Co., Inc ., Kenilworth, NJ, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200804
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Antibodies, Bacterial
MH  - Canada
MH  - Child
MH  - Diphtheria-Tetanus-Pertussis Vaccine/adverse effects
MH  - *Haemophilus Vaccines/adverse effects
MH  - *Haemophilus influenzae type b
MH  - Hepatitis B Vaccines
MH  - Humans
MH  - Infant
MH  - Infant, Low Birth Weight
MH  - Infant, Newborn
MH  - Infant, Premature
MH  - Poliovirus Vaccine, Inactivated/adverse effects
MH  - Vaccines, Combined/adverse effects
PMC - PMC7872088
OTO - NOTNLM
OT  - DTaP-IPV-Hib-HepB Vaccine
OT  - Safety
OT  - immunogenicity
OT  - integrated analyses
OT  - premature infants
EDAT- 2020/08/05 06:00
MHDA- 2021/06/22 06:00
PMCR- 2020/08/04
CRDT- 2020/08/05 06:00
PHST- 2020/08/05 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/08/05 06:00 [entrez]
PHST- 2020/08/04 00:00 [pmc-release]
AID - 1756668 [pii]
AID - 10.1080/21645515.2020.1756668 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2021 Jan 2;17(1):191-196. doi: 
      10.1080/21645515.2020.1756668. Epub 2020 Aug 4.