PMID- 28825515
OWN - NLM
STAT- MEDLINE
DCOM- 20171127
LR  - 20180207
IS  - 1941-9260 (Electronic)
IS  - 0032-5481 (Linking)
VI  - 129
IP  - 8
DP  - 2017 Nov
TI  - Safety and effectiveness assessment of 2011-2012 seasonal influenza vaccine 
      produced in China: a randomized trial.
PG  - 907-914
LID - 10.1080/00325481.2017.1369133 [doi]
AB  - OBJECTIVE: This study evaluated the effectiveness and safety of the egg-based, 
      trivalent, inactivated split influenza vaccine produced by the Institute of 
      Medical Biology, Chinese Academy of Medical Sciences, Peking Union Medical 
      College, China. METHODS: From March 2012 through May 2012, we enrolled a total of 
      1390 healthy volunteers between the ages of 3 and 80 years in a randomized 
      clinical trial at the Hebei Disease Control Center Vaccine Clinical Evaluation 
      Center. For all subjects, body part adverse reactions and whole-body adverse 
      reactions were observed 30 min, 6 h, and 1-7 days' post-inoculation. If no severe 
      adverse effects were observed 7 days' post-vaccination, the local and systemic 
      reactions of preliminary test participants were recorded until day 28. There was 
      no placebo group in this study. Blood samples were taken for serological testing 
      before vaccination and 28 days' post-vaccination. RESULTS: Twenty-eight days 
      after vaccination, the seroconversion rates of experimental and control groups 
      were H1N1 75.3% and 75.7%, H3N2 75.8% and 71.8%, B 70.7% vs. 69.4%, (P > 0.05). 
      The antibody Geometric Mean Titer（GMT）of experimental and control groups were 
      H1N1 (179.7, 182.4), H3N2 (584.0, 445.7), B (201.4,191.6). The protection rate of 
      experimental and control groups was not statistically significant (H1N1: 86% vs. 
      87%, H3N2: 99% vs. 98%, B: 98% vs. 98%). Also, 95% confidence intervals of the 
      protection rate difference between the experimental and the control group were 
      H1N1: -0.1% (-4.1,3.8) %, H3N2: 0.3% (-1.0,1.7) % and B: 0.2% (-1.5,1.9) %; 
      confidence intervals exceeded the limit of -5%. The rates of adverse reactions 
      between experimental and control groups were 6.3% and 7.7% in local response 
      reactions, and 19.5% and 18.0% in systemic reactions. Three hundred and 
      twenty-seven adverse events (AEs) in 1200 (27.76%) subjects were reported within 
      28 d after vaccination. No serious adverse events occurred during the study. 
      CONCLUSIONS: The experimental vaccine three-antibody protection rate was 
      non-inferior to the control vaccine. Our results demonstrated that the 
      experimental vaccine achieved the primary immunogenic end point of the intended 
      clinical protocol, as well as a secondary immunogenic end-point, with an 
      acceptable level of safety. IRB approval for this study was issued under 
      #2012Y0005 and registered as Clinical Trial No. NCT01551810.
FAU - Jing-Xia, Gao
AU  - Jing-Xia G
AD  - a The fifth Department of Biological products , Institute of Medical Biology, 
      Chinese Academy of Medical Science and Peking Union Medical College , Kunming , 
      People's Republic of China.
FAU - Yu-Liang, Zhao
AU  - Yu-Liang Z
AD  - b The Vaccine Clinical Evaluation Center Department , Hebei Province Center for 
      Disease Prevention and Control , Hebei , People's Republic of China.
FAU - Jin-Feng, Liu
AU  - Jin-Feng L
AD  - c Dingxing County Center for Disease Prevention and Control, Dingxing County , 
      Hebei Province , China.
FAU - Shu-Zhen, Liu
AU  - Shu-Zhen L
AD  - d National Institutes for Food and Drug Control , Beijing , China.
FAU - Guo-Yang, Liao
AU  - Guo-Yang L
AD  - a The fifth Department of Biological products , Institute of Medical Biology, 
      Chinese Academy of Medical Science and Peking Union Medical College , Kunming , 
      People's Republic of China.
FAU - Qi, Li
AU  - Qi L
AD  - b The Vaccine Clinical Evaluation Center Department , Hebei Province Center for 
      Disease Prevention and Control , Hebei , People's Republic of China.
LA  - eng
SI  - ClinicalTrials.gov/NCT01551810
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170905
PL  - England
TA  - Postgrad Med
JT  - Postgraduate medicine
JID - 0401147
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Viral/blood
MH  - Child
MH  - Child, Preschool
MH  - China/epidemiology
MH  - Female
MH  - Humans
MH  - Influenza Vaccines/*administration & dosage/*adverse effects
MH  - Influenza, Human/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Seasons
MH  - Seroconversion/physiology
MH  - Single-Blind Method
MH  - Young Adult
OTO - NOTNLM
OT  - Chinese new production
OT  - Safety
OT  - effectiveness
OT  - geometric mean titer
OT  - randomized clinical trial
OT  - seasonal influenza vaccine
OT  - seroconversion
EDAT- 2017/08/22 06:00
MHDA- 2017/11/29 06:00
CRDT- 2017/08/22 06:00
PHST- 2017/08/22 06:00 [pubmed]
PHST- 2017/11/29 06:00 [medline]
PHST- 2017/08/22 06:00 [entrez]
AID - 10.1080/00325481.2017.1369133 [doi]
PST - ppublish
SO  - Postgrad Med. 2017 Nov;129(8):907-914. doi: 10.1080/00325481.2017.1369133. Epub 
      2017 Sep 5.