PMID- 24108780
OWN - NLM
STAT- MEDLINE
DCOM- 20140808
LR  - 20211021
IS  - 1556-679X (Electronic)
IS  - 1556-6811 (Print)
IS  - 1556-679X (Linking)
VI  - 20
IP  - 12
DP  - 2013 Dec
TI  - Immunogenicity, safety, and lot consistency of a novel inactivated enterovirus 71 
      vaccine in Chinese children aged 6 to 59 months.
PG  - 1805-11
LID - 10.1128/CVI.00491-13 [doi]
AB  - The determination of lot-to-lot consistency in the manufacturing process is a 
      mandatory step in the clinical development of the novel enterovirus 71 (EV71) 
      vaccine. A phase III, randomized, placebo-controlled, double-blind trial assessed 
      the lot consistency, immunogenicity, and safety of the EV71 vaccine in children 
      aged 6 to 59 months. Healthy children (n = 1,400) received one of three lots of 
      the EV71 vaccine containing 400 U of EV71 antigen or a placebo at days 0 and 28. 
      Blood samples were collected before dose 1 and at 28 days after dose 2 (day 56) 
      for an anti-EV71 neutralizing antibody (NTAb) assay. The geometric mean titer 
      (GMT) and the seropositivity rates (with titers of >/=1:8) were compared at day 56. 
      After each dose, the solicited injection site and general adverse events (AEs) 
      were recorded for 7 days, and unsolicited AEs were recorded for 28 days. At day 
      56, the seropositivity rates ranged from 99.7% to 100% for the vaccine groups. 
      The NTAb GMTs for the vaccine were 140.3 (95% confidence interval [CI], 117.8 to 
      167.1), 141.5 (95% CI, 118.0 to 169.6), and 146.6 (95% CI, 122.5 to 175.3). The 
      two-sided 95% CI of the log difference in GMTs between the pairs of lots were 
      between -0.176 and 0.176, therefore meeting the predefined equivalence criteria. 
      The percentages of subjects reporting any injection site AEs, general AEs, or 
      serious AEs were similar across the four vaccination groups. In conclusion, the 
      demonstration of consistency between the manufacturing lots confirms for the 
      purposes of clinical development the reliability of the EV71 vaccine production 
      process. (This study has been registered at ClinicalTrials.gov under registration 
      no. NCT01636245.).
FAU - Hu, Yue-Mei
AU  - Hu YM
AD  - Jiang-Su Provincial Center for Disease Control and Prevention, Nanjing, China.
FAU - Wang, Xu
AU  - Wang X
FAU - Wang, Jun-Zhi
AU  - Wang JZ
FAU - Wang, Ling
AU  - Wang L
FAU - Zhang, Yong-Jie
AU  - Zhang YJ
FAU - Chang, Lin
AU  - Chang L
FAU - Liang, Zheng-Lun
AU  - Liang ZL
FAU - Xia, Jie-Lai
AU  - Xia JL
FAU - Dai, Qi-Gang
AU  - Dai QG
FAU - Hu, Ya-Ling
AU  - Hu YL
FAU - Mao, Qun-Ying
AU  - Mao QY
FAU - Zhu, Feng-Cai
AU  - Zhu FC
FAU - Song, Yu-Fei
AU  - Song YF
FAU - Gao, Fan
AU  - Gao F
FAU - Chen, Jiang-Ting
AU  - Chen JT
LA  - eng
SI  - ClinicalTrials.gov/NCT01636245
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20131009
PL  - United States
TA  - Clin Vaccine Immunol
JT  - Clinical and vaccine immunology : CVI
JID - 101252125
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Placebos)
RN  - 0 (Vaccines, Inactivated)
RN  - 0 (Viral Vaccines)
SB  - IM
MH  - Antibodies, Neutralizing/*blood
MH  - Antibodies, Viral/*blood
MH  - Child, Preschool
MH  - China
MH  - Double-Blind Method
MH  - Enterovirus A, Human/*immunology
MH  - Enterovirus Infections/immunology/*prevention & control
MH  - Female
MH  - Humans
MH  - Infant
MH  - Male
MH  - Placebos
MH  - Vaccination/adverse effects
MH  - Vaccines, Inactivated/administration & dosage/adverse effects/immunology
MH  - Viral Vaccines/administration & dosage/adverse effects/*immunology
PMC - PMC3889509
EDAT- 2013/10/11 06:00
MHDA- 2014/08/13 06:00
PMCR- 2014/06/01
CRDT- 2013/10/11 06:00
PHST- 2013/10/11 06:00 [entrez]
PHST- 2013/10/11 06:00 [pubmed]
PHST- 2014/08/13 06:00 [medline]
PHST- 2014/06/01 00:00 [pmc-release]
AID - CVI.00491-13 [pii]
AID - 00491-13 [pii]
AID - 10.1128/CVI.00491-13 [doi]
PST - ppublish
SO  - Clin Vaccine Immunol. 2013 Dec;20(12):1805-11. doi: 10.1128/CVI.00491-13. Epub 
      2013 Oct 9.