PMID- 30882742
OWN - NLM
STAT- MEDLINE
DCOM- 20200318
LR  - 20240229
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
VI  - 38
IP  - 4
DP  - 2019 Apr
TI  - Integrated Safety Profile of a New Approved, Fully Liquid DTaP5-HB-IPV-Hib 
      Vaccine.
PG  - 439-443
LID - 10.1097/INF.0000000000002257 [doi]
AB  - BACKGROUND: DTaP5-HB-IPV-Hib is a fully liquid, hexavalent vaccine containing a 
      5-antigen pertussis component, approved since 2016 in Europe [Vaxelis; 
      DTaP5-HB-IPV-Hib vaccine: Diphtheria, tetanus, pertussis (5 acellular components: 
      pertussis toxoid [PT], filamentous haemagglutinin [FHA], pertactin (PRN), and 
      fimbriae Types 2 and 3 [FIM]), hepatitis B (recombinant DNA: rDNA), poliomyelitis 
      (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed); MCM 
      Vaccine B.V., The Netherlands] for primary and booster vaccination in infants and 
      toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and 
      invasive diseases caused by Haemophilus influenzae type b. The comparator vaccine 
      (control) was INFANRIX hexa (GlaxoSmithKline Biologics S.A., Rixensart, Belgium) 
      (DTaP3-IPV-HepB/Hib) in European studies and PENTACEL (DTaP5-IPV/Hib) (Sanofi 
      Pasteur, Swiftwater, PA) in US studies. METHODS: Data from 6 studies were 
      integrated and analyzed to provide a comprehensive safety profile. Numbers and 
      proportions of subjects with adverse events (AEs) were summarized by treatment 
      group. Group differences in proportion of AEs were calculated. RESULTS: Among the 
      DTaP5-HB-IPV-Hib (N = 5223) and 2295 control (N = 2295) groups, solicited 
      injection-site and systemic AEs were very common. Serious AEs were reported by 
      3.9% of DTaP5-HB-IPV-Hib and 3.7% of control subjects. Vaccine-related serious 
      AEs occurred infrequently, 0.2% for both groups. Most AEs were mild-to-moderate 
      and did not lead to subject withdrawal. Group differences for solicited systemic 
      AEs were small (<3%) and not statistically significant, except for pyrexia 
      (estimated difference 9.4% [95% CI: 6.7%-12%]). The difference was driven by the 
      2 US studies where the PENTACEL control group had a lower fever rate. Among 
      European studies, there was no significant difference in rates of pyrexia between 
      DTaP5-HB-IPV-Hib and INFANRIX hexa. CONCLUSIONS: The safety of DTaP5-HB-IPV-Hib 
      is consistent with the safety profile of its components and similar to comparator 
      vaccines, including INFANRIX hexa. The vaccine provides a new, fully liquid and 
      convenient hexavalent vaccination option for use with various vaccination 
      schedules in Europe.
FAU - Xu, Jin
AU  - Xu J
AD  - From the Merck & Co., Inc., Kenilworth, NJ.
FAU - Stek, Jon E
AU  - Stek JE
FAU - Ziani, Eddy
AU  - Ziani E
FAU - Liu, G Frank
AU  - Liu GF
FAU - Lee, Andrew W
AU  - Lee AW
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Vaxelis)
SB  - IM
MH  - Child, Preschool
MH  - Diphtheria/prevention & control
MH  - Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage/*adverse effects
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/pathology
MH  - Female
MH  - Haemophilus Infections/prevention & control
MH  - Haemophilus Vaccines/administration & dosage/*adverse effects
MH  - Hepatitis B
MH  - Hepatitis B Vaccines/administration & dosage/*adverse effects
MH  - Humans
MH  - Infant
MH  - Male
MH  - Poliomyelitis/prevention & control
MH  - Poliovirus Vaccine, Inactivated/administration & dosage/*adverse effects
MH  - Tetanus/prevention & control
MH  - Vaccines, Combined/administration & dosage/adverse effects
MH  - Whooping Cough/prevention & control
EDAT- 2019/03/19 06:00
MHDA- 2020/03/19 06:00
CRDT- 2019/03/19 06:00
PHST- 2019/03/19 06:00 [entrez]
PHST- 2019/03/19 06:00 [pubmed]
PHST- 2020/03/19 06:00 [medline]
AID - 00006454-201904000-00024 [pii]
AID - 10.1097/INF.0000000000002257 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2019 Apr;38(4):439-443. doi: 10.1097/INF.0000000000002257.