PMID- 38327239
OWN - NLM
STAT- MEDLINE
DCOM- 20240209
LR  - 20240211
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 20
IP  - 1
DP  - 2024 Dec 31
TI  - A phase 4, open-label study to evaluate the safety and immunogenicity of 
      DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or 
      DTaP5-HBV-IPV-Hib (V419-016).
PG  - 2310900
LID - 10.1080/21645515.2024.2310900 [doi]
LID - 2310900
AB  - DTaP5-HBV-IPV-Hib (Vaxelis(R)) is a hexavalent combination vaccine (HV) indicated 
      in infants and toddlers for the prevention of diphtheria, tetanus, pertussis, 
      hepatitis B, poliomyelitis, and invasive disease due to Haemophilus influenzae 
      type b. Switching between HVs during the childhood vaccination series is 
      sometimes necessary due to, for example, vaccine availability, health-care 
      provider preference, and/or tender awards. The purpose of this study was to 
      describe the safety, tolerability, and immunogenicity of a booster dose of 
      Vaxelis(R) in participants who previously received a primary infant series of 
      either DTaP2-HBV-IPV-Hib (Hexyon(R)) or Vaxelis(R). Healthy participants 
      approximately 11-13 months of age who previously received a two-dose primary 
      series of Hexyon(R) (HHV group) or Vaxelis(R) (VVV group) all received a Vaxelis(R) 
      booster dose. Immunogenicity was evaluated by measuring antibody levels to 
      individual vaccine antigens approximately 30 days following booster vaccination. 
      Safety was evaluated as the proportion of participants with adverse events (AEs). 
      The proportions of participants with antibody-specific responses for antigens 
      contained in both Vaxelis(R) and Hexyon(R) at 30 days post-toddler-booster 
      vaccination with Vaxelis(R) were comparable between groups, and higher in the VVV 
      group for Vaxelis(R) antigens PRN and FIM2/3. The overall proportions of 
      participants with AEs were generally comparable between groups. Following a 
      booster dose of Vaxelis(R), immune responses were comparable between groups for all 
      shared antigens, and higher in the VVV group for antigens found only in Vaxelis(R). 
      The booster was well tolerated in both groups. These data support the use of 
      Vaxelis(R) as a booster in mixed HV regimens.
FAU - Guerra, Andrea
AU  - Guerra A
AD  - Research, MSD (UK) Limited, London, UK.
FAU - Costantino, Claudio
AU  - Costantino C
AD  - Department of Health Promotion Sciences, Maternal and Infant Care, Internal 
      Medicine and Excellence Specialties, University of Palermo, Palermo, Italy.
FAU - Martinon-Torres, Federico
AU  - Martinon-Torres F
AD  - Translational Pediatrics and Infectious Diseases, Hospital Clinico Universitario 
      de Santiago, Santiago de Compostela, Spain.
AD  - GENVIP Research Group (www.genvip.eu), Instituto de Investigacion Sanitaria de 
      Santiago, Universidad de Santiago de Compostela, Santiago de Compostela, Spain.
AD  - Centro de Investigacion Biomedica en Red de Enfermedades Respiratorias (CIBERES), 
      Instituto de Salud Carlos III, Madrid, Spain.
FAU - Westerholt, Soeren
AU  - Westerholt S
AD  - Pediatrics, Praxis fur Kinder- und Jugendmedizin, Wolfsburg, Germany.
FAU - Lambeth, Courtney
AU  - Lambeth C
AD  - Research, Merck & Co., Inc., Rahway, USA.
FAU - Chen, Ziqiang
AU  - Chen Z
AD  - Research, Merck & Co., Inc., Rahway, USA.
FAU - Lumley, Jessie
AU  - Lumley J
AD  - Research, Merck & Co., Inc., Rahway, USA.
FAU - Marcek, Tomas
AU  - Marcek T
AD  - Vaccine, MCM Vaccine B.V, Leiden, Netherlands.
FAU - Johnson, David
AU  - Johnson D
AD  - Vaccine, Sanofi Vaccines, Swiftwater, USA.
FAU - Wilck, Marissa
AU  - Wilck M
AUID- ORCID: 0000-0002-6890-1118
AD  - Research, Merck & Co., Inc., Rahway, USA.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
DEP - 20240208
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Antibodies, Bacterial)
SB  - IM
MH  - Humans
MH  - Infant
MH  - *Haemophilus influenzae type b
MH  - Hepatitis B virus
MH  - Diphtheria-Tetanus-Pertussis Vaccine
MH  - Vaccines, Combined
MH  - *Tetanus/prevention & control
MH  - *Diphtheria/prevention & control
MH  - *Whooping Cough/prevention & control
MH  - Poliovirus Vaccine, Inactivated
MH  - Hepatitis B Vaccines
MH  - *Haemophilus Vaccines
MH  - Immunization Schedule
MH  - Antibodies, Bacterial
PMC - PMC10857551
OTO - NOTNLM
OT  - V419
OT  - Vaxelis
OT  - hexavalent combination vaccine
OT  - immunogenicity
OT  - interchangeability
OT  - pediatric
OT  - safety
OT  - vaccine
COIS- A.G., C.L., Z.C., J.L., and M.W. are employees of MSD and may hold stock in Merck 
      & Co., Inc., Rahway, NJ, USA. F.M.-T. has received honoraria from Astra Zeneca, 
      GSK, Pfizer Inc, Sanofi, MSD, Seqirus, Moderna, Novavax, Biofabri, and Janssen 
      for taking part in advisory boards and expert meetings and for acting as a 
      speaker in congresses outside the scope of the submitted work. F.M.-T. has also 
      acted as principal investigator in randomized controlled trials of the 
      above-mentioned companies as well as Ablynx, Gilead, Regeneron, Roche, Abbott, 
      and MedImmune, with honoraria paid to his institution. T.M. is an employee of MCM 
      Vaccine B.V. D.J. is a full-time employee of Sanofi Vaccines, and annually 
      receives Sanofi stock options. All other authors have no relevant conflicts of 
      interest to disclose.
EDAT- 2024/02/08 06:42
MHDA- 2024/02/09 06:43
PMCR- 2024/02/08
CRDT- 2024/02/08 03:59
PHST- 2024/02/09 06:43 [medline]
PHST- 2024/02/08 06:42 [pubmed]
PHST- 2024/02/08 03:59 [entrez]
PHST- 2024/02/08 00:00 [pmc-release]
AID - 2310900 [pii]
AID - 10.1080/21645515.2024.2310900 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2024 Dec 31;20(1):2310900. doi: 
      10.1080/21645515.2024.2310900. Epub 2024 Feb 8.