PMID- 38242195
OWN - NLM
STAT- MEDLINE
DCOM- 20240315
LR  - 20240315
IS  - 1878-3511 (Electronic)
IS  - 1201-9712 (Linking)
VI  - 141
DP  - 2024 Apr
TI  - A phase 3 randomized study to evaluate safety and immunogenicity of 20-valent 
      pneumococcal conjugate vaccine in healthy Japanese infants.
PG  - 106942
LID - S1201-9712(24)00010-9 [pii]
LID - 10.1016/j.ijid.2024.01.009 [doi]
AB  - OBJECTIVES: Safety and immunogenicity evaluation of a 4-dose series with 
      20-valent pneumococcal conjugate vaccine (PCV20). METHODS: This phase 3, 
      double-blind study randomized healthy Japanese infants to receive 4 doses (3 
      infant doses, 1 toddler dose) of PCV20 by subcutaneous (SC) or intramuscular (IM) 
      injection or 13-valent PCV (PCV13) SC. A primary immunogenicity objective was to 
      demonstrate noninferiority of PCV20 SC to PCV13 SC for percentages of 
      participants meeting predefined serotype-specific immunoglobulin G concentrations 
      1 month after Dose 3. The 7 additional PCV20 serotypes were compared with the 
      lowest vaccine serotype result in the PCV13 group. Safety and tolerability were 
      assessed as the primary safety objective. RESULTS: Overall, 668 participants were 
      randomized (PCV20 SC, n = 226; PCV13 SC, n = 224; PCV20 IM, n = 218). The primary 
      noninferiority objective for PCV20 SC to PCV13 SC was met for 11/13 matched and 
      5/7 additional serotypes. Additional data showed PCV20 SC and IM elicited robust 
      functional opsonophagocytic activity and boosting responses to all 20 vaccine 
      serotypes. PCV20 had a similar safety/tolerability profile to PCV13, although 
      local reactions were less frequent with PCV20 IM. CONCLUSIONS: A 4-dose series of 
      PCV20 SC or IM elicited immune responses expected to be protective against all 20 
      serotypes in Japanese infants. NCT04530838.
CI  - Copyright (c) 2024. Published by Elsevier Ltd.
FAU - Ishihara, Yasunori
AU  - Ishihara Y
AD  - Department of Pediatrics, Fukui Aiiku Hospital, Fukui, Japan.
FAU - Fukazawa, Mitsuru
AU  - Fukazawa M
AD  - Fukazawa Clinic, Fukuoka, Japan.
FAU - Enomoto, Shinya
AU  - Enomoto S
AD  - Enomoto Clinic, Saitama, Japan.
FAU - de Solom, Richard
AU  - de Solom R
AD  - Vaccine Clinical Research & Development, Pfizer Australia, Sydney, NSW, 
      Australia.
FAU - Yamaji, Masako
AU  - Yamaji M
AD  - Vaccine Research, Pfizer R&D Japan, Tokyo, Japan.
FAU - Kline, Mary
AU  - Kline M
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. Electronic 
      address: Mary.Kline@pfizer.com.
FAU - Aizawa, Masakazu
AU  - Aizawa M
AD  - Vaccine Research, Pfizer R&D Japan, Tokyo, Japan.
FAU - Peng, Yahong
AU  - Peng Y
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
FAU - Kogawara, Osamu
AU  - Kogawara O
AD  - Vaccine Research, Pfizer R&D Japan, Tokyo, Japan.
FAU - Giardina, Peter C
AU  - Giardina PC
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
FAU - Tamimi, Noor
AU  - Tamimi N
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
FAU - Gruber, William C
AU  - Gruber WC
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
FAU - Watson, Wendy
AU  - Watson W
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT04530838
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20240117
PL  - Canada
TA  - Int J Infect Dis
JT  - International journal of infectious diseases : IJID : official publication of the 
      International Society for Infectious Diseases
JID - 9610933
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Immunoglobulin G)
SB  - IM
MH  - Infant
MH  - Humans
MH  - *Pneumococcal Vaccines
MH  - Vaccines, Conjugate
MH  - Japan
MH  - Antibodies, Bacterial
MH  - Immunoglobulin G
MH  - Double-Blind Method
MH  - *Pneumococcal Infections/prevention & control
OTO - NOTNLM
OT  - 20-valent pneumococcal conjugate vaccine
OT  - Immunogenicity
OT  - Infants
OT  - Japan
OT  - Safety
COIS- Declaration of competing interest The authors declare the following financial 
      interests/personal relationships which may be considered as potential competing 
      interests: Yasunori Ishihara, Mitsuru Fukazawa, and Shinya Enomoto are study 
      investigators for Pfizer and have no other conflicts to declare. All other 
      authors are current employees of Pfizer or were employees at the time of the 
      study and may hold stock or stock options.
EDAT- 2024/01/20 05:42
MHDA- 2024/03/15 06:44
CRDT- 2024/01/19 19:13
PHST- 2023/10/26 00:00 [received]
PHST- 2023/12/20 00:00 [revised]
PHST- 2024/01/14 00:00 [accepted]
PHST- 2024/03/15 06:44 [medline]
PHST- 2024/01/20 05:42 [pubmed]
PHST- 2024/01/19 19:13 [entrez]
AID - S1201-9712(24)00010-9 [pii]
AID - 10.1016/j.ijid.2024.01.009 [doi]
PST - ppublish
SO  - Int J Infect Dis. 2024 Apr;141:106942. doi: 10.1016/j.ijid.2024.01.009. Epub 2024 
      Jan 17.