PMID- 36882898
OWN - NLM
STAT- MEDLINE
DCOM- 20230316
LR  - 20230330
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 19
IP  - 1
DP  - 2023 Dec 31
TI  - Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in 
      Japanese healthy infants: A Phase I study (V114-028).
PG  - 2180973
LID - 10.1080/21645515.2023.2180973 [doi]
LID - 2180973
AB  - This Phase I study evaluated the safety, tolerability, and immunogenicity of 
      V114, a 15-valent pneumococcal conjugate vaccine (PCV), via subcutaneous (SC) or 
      intramuscular (IM) administration, in healthy Japanese infants 3 months of age. A 
      total of 133 participants were randomized to receive four doses (3 + 1 regimen) 
      of V114-SC (n = 44), V114-IM (n = 45), or 13-valent PCV (PCV13)-SC (n = 44) at 3, 
      4, 5, and 12-15 months of age. Diphtheria, tetanus, and pertussis-inactivated 
      poliovirus (DTaP-IPV) vaccine was administered concomitantly at all vaccination 
      visits. The primary objective was to assess the safety and tolerability of 
      V114-SC and V114-IM. Secondary objectives were to assess the immunogenicity of 
      PCV and DTaP-IPV at 1-month post-dose 3 (PD3). On days 1-14 following each 
      vaccination, the proportions of participants with systemic adverse events (AEs) 
      were comparable across interventions, whereas injection-site AEs were higher with 
      V114-SC (100.0%) and PCV13-SC (100.0%) than with V114-IM (88.9%). Most AEs were 
      mild or moderate in severity and no vaccine-related serious AEs or deaths were 
      reported. Serotype-specific immunoglobulin G (IgG) response rates at 1-month PD3 
      were comparable across groups for most shared serotypes between V114 and PCV13. 
      For additional V114 serotypes 22F and 33F, IgG response rates were higher with 
      V114-SC and V114-IM than with PCV13-SC. DTaP-IPV antibody response rates at 
      1-month PD3 for V114-SC and V114-IM were comparable with PCV13-SC. Findings 
      suggest that vaccination with V114-SC or V114-IM in healthy Japanese infants is 
      generally well tolerated and immunogenic.
FAU - Ishihara, Yasunori
AU  - Ishihara Y
AD  - Pediatrics, Fukui Aiiku Hospital, Fukui, Japan.
FAU - Kuroki, Haruo
AU  - Kuroki H
AD  - Pediatrics, Sotobo Children's Clinic, Chiba, Japan.
FAU - Hidaka, Hidenobu
AU  - Hidaka H
AD  - Pediatrics, Hidaka Children's Clinic, Fukuoka, Japan.
FAU - Iwai, Kazuyuki
AU  - Iwai K
AD  - Pediatrics, Fukui-ken Saiseikai Hospital, Fukui, Japan.
FAU - Wan, Keiko
AU  - Wan K
AD  - Japan Development, MSD K.K, Tokyo, Japan.
FAU - Shirakawa, Masayoshi
AU  - Shirakawa M
AD  - Japan Development, MSD K.K, Tokyo, Japan.
FAU - Sawata, Miyuki
AU  - Sawata M
AD  - Japan Development, MSD K.K, Tokyo, Japan.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230307
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Tetanus Toxoid)
RN  - 0 (Vaccines, Conjugate)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Humans
MH  - Infant
MH  - Antibodies, Bacterial
MH  - East Asian People
MH  - *Immunogenicity, Vaccine
MH  - Immunoglobulin G
MH  - *Pneumococcal Infections/prevention & control
MH  - *Pneumococcal Vaccines/immunology
MH  - Poliovirus Vaccine, Inactivated
MH  - Tetanus Toxoid
MH  - Vaccines, Conjugate
MH  - Vaccines, Combined
PMC - PMC10026902
OTO - NOTNLM
OT  - Clinical trial
OT  - DTaP-IPV
OT  - Japan
OT  - PCV13
OT  - PCV15
OT  - child
OT  - infant
OT  - pneumococcal infections
OT  - pneumococcal vaccines
COIS- H.K. has received honoraria for lectures from MSD K.K. K.W., M. Shirakawa and M. 
      Sawata are employees of MSD K.K., Tokyo, Japan and may own stock and/or stock 
      options in Merck & Co., Inc., Rahway, NJ, USA. Y.I., H.H., and K.I. have no 
      conflicts of interest to report.
EDAT- 2023/03/08 06:00
MHDA- 2023/03/17 06:00
PMCR- 2023/03/07
CRDT- 2023/03/07 23:52
PHST- 2023/03/08 06:00 [pubmed]
PHST- 2023/03/17 06:00 [medline]
PHST- 2023/03/07 23:52 [entrez]
PHST- 2023/03/07 00:00 [pmc-release]
AID - 2180973 [pii]
AID - 10.1080/21645515.2023.2180973 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2023 Dec 31;19(1):2180973. doi: 
      10.1080/21645515.2023.2180973. Epub 2023 Mar 7.