PMID- 35908869
OWN - NLM
STAT- MEDLINE
DCOM- 20221125
LR  - 20221125
IS  - 1884-2836 (Electronic)
IS  - 1344-6304 (Linking)
VI  - 75
IP  - 6
DP  - 2022 Nov 22
TI  - Safety and Immunogenicity of V114, a 15-valent Pneumococcal Conjugate Vaccine, 
      Compared with 13-valent Pneumococcal Conjugate Vaccine in Japanese Adults Aged 
      >/=65 Years: Subgroup Analysis of a Randomized Phase III Trial (PNEU-AGE).
PG  - 575-582
LID - 10.7883/yoken.JJID.2022.060 [doi]
AB  - The safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine 
      (PCV), were assessed in a pivotal phase III trial conducted in healthy adults >/=50 
      years of age (NCT03950622, Japic-CTI 194845). We performed a subgroup analysis of 
      245 Japanese participants (all >/=65 years of age). The participants were 
      randomized 1:1 to receive a single dose of V114 or 13-valent PCV (PCV13). Immune 
      responses were evaluated at baseline and at 30 days post-vaccination. Non-serious 
      and serious adverse events (AEs) were evaluated at 14 days and 6 months after 
      vaccination, respectively. The proportions of participants experiencing solicited 
      and serious AEs were comparable for both vaccines, and all solicited AEs were 
      mild or moderate in severity. Geometric mean titers of serotype-specific 
      opsonophagocytic activity (OPA) at 30 days post-vaccination were comparable 
      between groups for all 13 shared serotypes and were higher with V114 for the 
      unique serotypes 22F and 33F. The proportion of participants with a >/=4-fold 
      increase in serotype-specific OPA responses from pre-vaccination to 30 days 
      post-vaccination was higher for V114 than for PCV13 for serotypes 3, 22F, and 
      33F. V114 was well tolerated and immunogenic in Japanese adults >/=65 years of age, 
      showing safety and immunogenicity profiles consistent with those seen in the 
      overall study population.
FAU - Kishino, Hiroyuki
AU  - Kishino H
AD  - Vaccines, Clinical Research, Japan Development, MSD K.K., Japan.
FAU - Sawata, Miyuki
AU  - Sawata M
AD  - Vaccines, Clinical Research, Japan Development, MSD K.K., Japan.
FAU - Igarashi, Rie
AU  - Igarashi R
AD  - Clinical Science, Clinical Research, Japan Development, MSD K.K., Japan.
FAU - Shirakawa, Masayoshi
AU  - Shirakawa M
AD  - Biostatistics and Research Decision Sciences, Japan Development, MSD K.K., Japan.
FAU - Pedley, Alison
AU  - Pedley A
AD  - Biostatistics and Research Decision Sciences, Merck & Co., Inc., USA.
FAU - Musey, Luwy
AU  - Musey L
AD  - Vaccines, Clinical Research, Merck & Co., Inc., USA.
FAU - Platt, Heather Loryn
AU  - Platt HL
AD  - Vaccines, Clinical Research, Merck & Co., Inc., USA.
FAU - Buchwald, Ulrike Kirsten
AU  - Buchwald UK
AD  - Vaccines, Clinical Research, Merck & Co., Inc., USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220729
PL  - Japan
TA  - Jpn J Infect Dis
JT  - Japanese journal of infectious diseases
JID - 100893704
RN  - 0 (Vaccines, Conjugate)
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Pneumococcal Vaccines)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Middle Aged
MH  - Aged
MH  - Vaccines, Conjugate/adverse effects
MH  - Japan
MH  - *Streptococcus pneumoniae
MH  - Antibodies, Bacterial
MH  - Pneumococcal Vaccines/adverse effects
MH  - Serogroup
MH  - *Pneumococcal Infections/prevention & control
OTO - NOTNLM
OT  - Japanese adults
OT  - immunogenicity
OT  - pneumococcal conjugate vaccine
OT  - safety
EDAT- 2022/08/01 06:00
MHDA- 2022/11/26 06:00
CRDT- 2022/07/31 21:43
PHST- 2022/08/01 06:00 [pubmed]
PHST- 2022/11/26 06:00 [medline]
PHST- 2022/07/31 21:43 [entrez]
AID - 10.7883/yoken.JJID.2022.060 [doi]
PST - ppublish
SO  - Jpn J Infect Dis. 2022 Nov 22;75(6):575-582. doi: 10.7883/yoken.JJID.2022.060. 
      Epub 2022 Jul 29.