PMID- 37549923
OWN - NLM
STAT- MEDLINE
DCOM- 20230822
LR  - 20230822
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 19
IP  - 2
DP  - 2023 Aug 1
TI  - A randomized, open-label, phase 3 study evaluating safety and immunogenicity of 
      13-valent pneumococcal conjugate vaccine in Chinese infants and children under 6 
      years of age.
PG  - 2235926
LID - 10.1080/21645515.2023.2235926 [doi]
LID - 2235926
AB  - Streptococcus pneumoniae causes a considerable disease burden among children in 
      China. Many isolates exhibit antimicrobial resistance but are often serotypes 
      covered by the 13-valent pneumococcal conjugate vaccine (PCV13). Because the 
      approved infant immunization schedule in China allows PCV13 vaccination only for 
      those 6 weeks to 15 months of age, this phase 3 study was conducted to evaluate 
      PCV13 immunogenicity and safety in unvaccinated older infants and children. 
      Eligible participants were stratified by age into four cohorts: Cohort 1 
      (n = 125), 6 weeks-2 months; Cohort 2 (n = 354), 7-<12 months; Cohort 3 
      (n = 250), 1 -<2 years; Cohort 4 (n = 207), 2-<6 years. Cohort 1 received PCV13 
      at ages 2, 4, and 6 months; older cohorts were randomized 2:1 to PCV13 or 
      Haemophilus influenzae type b (Hib) vaccine using age-appropriate schedules. 
      Within-group immune responses were assessed by immunoglobulin G (IgG) 
      concentrations and opsonophagocytic activity (OPA) titers. Safety evaluations 
      included solicited reactogenicity events and adverse events (AEs). IgG geometric 
      mean concentrations and OPA geometric mean titers for all 13 PCV13 serotypes 
      increased for all participants vaccinated with PCV13, but not those vaccinated 
      with Hib. Immune responses in Cohorts 2-4 were generally comparable with those in 
      Cohort 1 (the infant series) for most serotypes. PCV13 was well tolerated across 
      cohorts, with reported AEs consistent with expectations in these age groups; no 
      new safety signals were identified. These results suggest that PCV13 administered 
      as a catch-up regimen to infants and children 7 months-<6 years of age in China 
      will effectively reduce vaccine-type pneumococcal disease in this population. 
      NCT03574389.
FAU - Chu, Kai
AU  - Chu K
AD  - Department of Vaccine Clinical Evaluation, Jiangsu Center for Disease Control and 
      Prevention, Nanjing, JS, P. R. China.
FAU - Hu, Yuemei
AU  - Hu Y
AD  - Department of Vaccine Clinical Evaluation, Jiangsu Center for Disease Control and 
      Prevention, Nanjing, JS, P. R. China.
FAU - Pan, Hongxing
AU  - Pan H
AD  - Department of Vaccine Clinical Evaluation, Jiangsu Center for Disease Control and 
      Prevention, Nanjing, JS, P. R. China.
FAU - Wu, Jingliang
AU  - Wu J
AD  - Department of Infectious Disease, Huaiyin Center for Disease Control and 
      Prevention, Huai'an, JS, P. R. China.
FAU - Zhu, Dandan
AU  - Zhu D
AD  - Department of Infectious Disease, Huaiyin Center for Disease Control and 
      Prevention, Huai'an, JS, P. R. China.
FAU - Young, Mariano M Jr
AU  - Young MM Jr
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
FAU - Luo, Li
AU  - Luo L
AUID- ORCID: 0000-0002-6874-2161
AD  - Clinical Development, Pfizer Vaccine Research, Beijing, P. R. China.
FAU - Yi, Zhuobiao
AU  - Yi Z
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
FAU - Giardina, Peter C
AU  - Giardina PC
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
FAU - Gruber, William C
AU  - Gruber WC
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
FAU - Scott, Daniel A
AU  - Scott DA
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
FAU - Watson, Wendy
AU  - Watson W
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03574389
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
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 (Vaccines, Conjugate)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Child
MH  - Child, Preschool
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/therapeutic use
MH  - Streptococcus pneumoniae
MH  - Vaccines, Conjugate/immunology/therapeutic use
MH  - Treatment Outcome
MH  - Vaccines, Combined/immunology/therapeutic use
PMC - PMC10408693
OTO - NOTNLM
OT  - China
OT  - PCV13
OT  - Streptococcus pneumoniae
OT  - clinical trial
OT  - immunogenicity
OT  - pediatric
OT  - pneumococcal conjugate vaccine
OT  - pneumococcal disease
OT  - safety
COIS- KC, YH, HP, JW, and DZ report no conflicts of interest. All other authors are 
      employees of Pfizer and may hold stock or stock options.
EDAT- 2023/08/08 00:42
MHDA- 2023/08/09 06:43
PMCR- 2023/08/07
CRDT- 2023/08/07 19:43
PHST- 2023/08/09 06:43 [medline]
PHST- 2023/08/08 00:42 [pubmed]
PHST- 2023/08/07 19:43 [entrez]
PHST- 2023/08/07 00:00 [pmc-release]
AID - 2235926 [pii]
AID - 10.1080/21645515.2023.2235926 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2023 Aug 1;19(2):2235926. doi: 
      10.1080/21645515.2023.2235926.