PMID- 28935470
OWN - NLM
STAT- MEDLINE
DCOM- 20180309
LR  - 20221207
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 35
IP  - 43
DP  - 2017 Oct 13
TI  - Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus 
      vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, 
      placebo-controlled trial.
PG  - 5897-5904
LID - S0264-410X(17)31181-7 [pii]
LID - 10.1016/j.vaccine.2017.08.081 [doi]
AB  - BACKGROUND: A randomized, double-blind, placebo-controlled multicenter trial was 
      conducted in healthy Chinese infants to assess the efficacy and safety of a 
      pentavalent live human-bovine reassortant rotavirus vaccine (RotaTeq, RV5) 
      against rotavirus gastroenteritis (RVGE). METHODS: 4040 participants aged 
      6-12weeks were enrolled and randomly assigned to either 3 oral doses of RV5 
      (n=2020) or placebo (n=2020), administered  approximately 4weeks apart. The participants also 
      received OPV and DTaP in a concomitant or staggered fashion. The primary 
      objective was to evaluate vaccine efficacy (VE) against naturally-occurring RVGE 
      at least 14days following the third dose. Key secondary objectives included: VE 
      against naturally-occurring severe RVGE and VE against severe and any-severity 
      RVGE caused by rotavirus serotypes contained in the vaccine, occurring at least 
      14days after the third dose. All adverse events (AEs) were collected for 30days 
      following each dose. Serious AEs (SAEs) and intussusception cases were collected 
      during the entire study. (ClinicalTrials.gov registry: NCT02062385). RESULTS: VE 
      against RVGE of any-severity caused by any serotype was 69.3% (95% CI: 54.5, 
      79.7). The secondary efficacy analysis showed an efficacy of: 78.9% (95% CI: 
      59.1, 90.1) against severe RVGE caused by any serotype; 69.9% (95% CI: 55.2, 
      80.3) and 78.9% (95% CI: 59.1, 90.1) against any-severity and severe RVGE caused 
      by serotypes contained in the vaccine, respectively. Within 30days following any 
      vaccination, 53.5% (1079/2015) and 53.3% (1077/2019) of participants reported at 
      least one AE, and 5.8% (116/2015) and 5.7% (116/2019) reported SAEs in the 
      vaccine and placebo groups, respectively. No SAEs were considered vaccine-related 
      in recipients of RV5. Two intussusception cases were reported in recipients of 
      RV5 who recovered after receiving treatment. Neither was considered 
      vaccine-related. CONCLUSIONS: In Chinese infants, RV5 was efficacious against 
      any-severity and severe RVGE caused by any serotype and generally well-tolerated 
      with respect to AEs.
CI  - Copyright (c) 2017. Published by Elsevier Ltd.
FAU - Mo, Zhaojun
AU  - Mo Z
AD  - Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.
FAU - Mo, Yi
AU  - Mo Y
AD  - Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.
FAU - Li, Mingqiang
AU  - Li M
AD  - Liuzhou City Center for Disease Control and Prevention, Liuzhou, Guangxi, China.
FAU - Tao, Junhui
AU  - Tao J
AD  - Liujiang County Center for Disease Control and Prevention, Liuzhou, Guangxi, 
      China.
FAU - Yang, Xu
AU  - Yang X
AD  - Sanjiang County Center for Disease Control and Prevention, Liuzhou, Guangxi, 
      China.
FAU - Kong, Jilian
AU  - Kong J
AD  - Liucheng County Center for Disease Control and Prevention, Liuzhou, Guangxi, 
      China.
FAU - Wei, Dingkai
AU  - Wei D
AD  - Rongan County Center for Disease Control and Prevention, Liuzhou, Guangxi, China.
FAU - Fu, Botao
AU  - Fu B
AD  - Luzhai County Center for Disease Control and Prevention, Liuzhou, Guangxi, China.
FAU - Liao, Xueyan
AU  - Liao X
AD  - Merck Sharp & Dohme R&D (China) Co., Ltd., Beijing, China.
FAU - Chu, Jianli
AU  - Chu J
AD  - Merck Sharp & Dohme R&D (China) Co., Ltd., Beijing, China.
FAU - Qiu, Yuanzheng
AU  - Qiu Y
AD  - Merck Sharp & Dohme R&D (China) Co., Ltd., Beijing, China.
FAU - Hille, Darcy A
AU  - Hille DA
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Nelson, Micki
AU  - Nelson M
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Kaplan, Susan S
AU  - Kaplan SS
AD  - Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: 
      susan_kaplan@merck.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02062385
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170919
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Rotavirus Vaccines)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Animals
MH  - Asian People
MH  - Cattle
MH  - Double-Blind Method
MH  - Female
MH  - Gastroenteritis/immunology/prevention & control
MH  - Humans
MH  - Infant
MH  - Infant Health
MH  - Male
MH  - Rotavirus/*immunology
MH  - Rotavirus Infections/*immunology/*prevention & control
MH  - Rotavirus Vaccines/*immunology
MH  - Severity of Illness Index
MH  - Vaccination/methods
MH  - Vaccines, Attenuated/*immunology
OTO - NOTNLM
OT  - Efficacy
OT  - Rotavirus gastroenteritis
OT  - Rotavirus vaccine
OT  - Safety
EDAT- 2017/09/25 06:00
MHDA- 2018/03/10 06:00
CRDT- 2017/09/23 06:00
PHST- 2017/05/02 00:00 [received]
PHST- 2017/08/21 00:00 [revised]
PHST- 2017/08/29 00:00 [accepted]
PHST- 2017/09/25 06:00 [pubmed]
PHST- 2018/03/10 06:00 [medline]
PHST- 2017/09/23 06:00 [entrez]
AID - S0264-410X(17)31181-7 [pii]
AID - 10.1016/j.vaccine.2017.08.081 [doi]
PST - ppublish
SO  - Vaccine. 2017 Oct 13;35(43):5897-5904. doi: 10.1016/j.vaccine.2017.08.081. Epub 
      2017 Sep 19.