PMID- 26044498
OWN - NLM
STAT- MEDLINE
DCOM- 20160315
LR  - 20150623
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 33
IP  - 30
DP  - 2015 Jul 9
TI  - Safety, tolerability, and immunogenicity of 7-valent pneumococcal conjugate 
      vaccine in older infants and young children in China who are naive to 
      pneumococcal vaccination: Results of a phase 4 open-label trial.
PG  - 3580-5
LID - S0264-410X(15)00694-5 [pii]
LID - 10.1016/j.vaccine.2015.05.042 [doi]
AB  - BACKGROUND: This postlicensure study was conducted to assess immunogenicity and 
      safety of PCV7 catch-up regimens in previously unvaccinated older infants and 
      young children in China. METHODS: Healthy children 121 days to <72 months were 
      grouped by age and immunized with 1 of 4 PCV7 dosing regimens. Serotype-specific 
      IgG geometric mean concentrations (GMCs) and percentage of subjects with 
      IgG>/=0.35mug/mL were assessed before vaccination and 1 and 12 months 
      postvaccination. The incidence of clinically important adverse events (AEs) and 
      serious AEs (SAEs), AEs leading to study withdrawal, and protocol-related AEs 
      were assessed throughout the study. RESULTS: Prevaccination serotype-specific 
      GMCs were generally low in subjects <24 months; the majority of children 24 to 
      <72 months had IgG concentrations >/=0.35 mug/mL. One month postvaccination, GMCs 
      were similar across groups for the 7 PCV serotypes, ranging from 3.95 to 13.02 
      mug/mL; the highest antibody levels were observed for serotype 14. Regardless of 
      dosing regimen, >90% of subjects had IgG>/=0.35 mug/mL for each PCV serotype. At 
      12-month follow-up, IgG GMCs ranged from 0.65 to 5.19, and all remained above 
      prevaccination IgG GMC; >70% of subjects had IgG>/=0.35 mug/mL. Older children 
      generally had the most robust immune response both at 1 month postvaccination and 
      during 12-month follow-up. PCV7 was well tolerated. Pyrexia, which was mild to 
      moderate in severity, was the most common AE. Two subjects reported SAEs (n=4), 
      and there was 1 study withdrawal; none of these were considered treatment 
      related. CONCLUSION: In China, PCV7 catch-up vaccinations given to older infants 
      and young children naive to pneumococcal vaccines resulted in a robust immune 
      response to all serotypes; this response persisted after 1 year. PCV7 was well 
      tolerated in Chinese infants and children.
CI  - Copyright (c) 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Li, Rongcheng
AU  - Li R
AD  - Guangxi Center for Disease Control and Prevention, Center for Vaccine Clinical 
      Research, Nanning, Guangxi Province, China.
FAU - Huang, Lirong
AU  - Huang L
AD  - Guangxi Center for Disease Control and Prevention, Center for Vaccine Clinical 
      Research, Nanning, Guangxi Province, China.
FAU - Mo, Shunping
AU  - Mo S
AD  - Yongfu Center for Disease Control and Prevention, Yongfu, Guangxi Province, 
      China.
FAU - Li, Junchun
AU  - Li J
AD  - Yongfu Center for Disease Control and Prevention, Board of Health, Yongfu, 
      Guangxi Province, China.
FAU - Zhou, Xin
AU  - Zhou X
AD  - Pfizer Inc, Shanghai, China.
FAU - Chen, Zhangjing
AU  - Chen Z
AD  - Pfizer Inc, Shanghai, China.
FAU - Liang, John
AU  - Liang J
AD  - Pfizer Inc, Collegeville, PA, USA.
FAU - Young, Mariano Jr
AU  - Young M Jr
AD  - Pfizer Inc, Collegeville, PA, USA. Electronic address: 
      mariano.young-jr@pfizer.com.
FAU - Giardina, Peter C
AU  - Giardina PC
AD  - Pfizer Inc, Pearl River, NY, USA.
FAU - Scott, Daniel A
AU  - Scott DA
AD  - Pfizer Inc, Pearl River, NY, USA.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150601
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Heptavalent Pneumococcal Conjugate Vaccine)
RN  - 0 (Immunoglobulin G)
SB  - IM
MH  - Antibodies, Bacterial/*blood
MH  - Child
MH  - Child, Preschool
MH  - China
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/pathology
MH  - Female
MH  - Healthy Volunteers
MH  - Heptavalent Pneumococcal Conjugate Vaccine/administration & dosage/*adverse 
      effects/*immunology
MH  - Humans
MH  - Immunoglobulin G/blood
MH  - Infant
MH  - Male
MH  - Treatment Outcome
MH  - Vaccination/*adverse effects/*methods
OTO - NOTNLM
OT  - Catch-up vaccination
OT  - Children
OT  - China
OT  - Infants
OT  - PCV7
OT  - S. pneumoniae
EDAT- 2015/06/06 06:00
MHDA- 2016/03/16 06:00
CRDT- 2015/06/06 06:00
PHST- 2014/12/23 00:00 [received]
PHST- 2015/05/07 00:00 [revised]
PHST- 2015/05/19 00:00 [accepted]
PHST- 2015/06/06 06:00 [entrez]
PHST- 2015/06/06 06:00 [pubmed]
PHST- 2016/03/16 06:00 [medline]
AID - S0264-410X(15)00694-5 [pii]
AID - 10.1016/j.vaccine.2015.05.042 [doi]
PST - ppublish
SO  - Vaccine. 2015 Jul 9;33(30):3580-5. doi: 10.1016/j.vaccine.2015.05.042. Epub 2015 
      Jun 1.