PMID- 24047799
OWN - NLM
STAT- MEDLINE
DCOM- 20150105
LR  - 20211021
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 10
IP  - 1
DP  - 2014
TI  - The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety 
      and reactogenicity.
PG  - 19-24
LID - 10.4161/hv.26476 [doi]
AB  - An integrated analysis of safety and reactogenicity data was undertaken for 28 
      randomized, placebo-controlled, double-blind Phase II and III trials (DBRCTs) of 
      the oral live-attenuated human rotavirus vaccine, Rotarix (GlaxoSmithKline 
      Vaccines). Healthy infants aged 6-20 wk received 2 or 3 doses of vaccine 
      (n=56562) or placebo (n=45512) at 4- to 8-wk intervals. Solicited adverse events 
      (AEs) were recorded for 8 d after each dose of vaccine or placebo. Unsolicited 
      AEs, serious AEs (SAEs), and deaths were evaluated over 31-d post-vaccination 
      follow-up periods. 95% confidence intervals (CIs) for the relative risk (RR) 
      across studies excluding "1.0" signified potential imbalances between the 2 
      groups. The incidence of each solicited AE of any or Grade 3 severity was similar 
      between groups. The incidence of all unsolicited AEs of any (RR=0.99 [95% CI: 
      0.94-1.04]; P=0.72) or Grade 3 severity (RR=0.91 [95% CI: 0.77-1.08]; P=0.31) was 
      similar between groups. A significantly higher proportion of SAEs were reported 
      in the placebo group compared with the vaccine group (RR=0.9 [95% CI: 0.82-0.98]; 
      P=0.01). The incidence of death was low and similar between the 2 groups (0.13% 
      in the vaccine group and 0.11% in the placebo group; RR=1.14 [95% CI: 0.78-1.68]; 
      P=0.54). Very few cases of intussusception were reported (11 and 7 in the vaccine 
      and placebo groups, respectively; RR=1.39 [95% CI: 0.49-4.27]; P=0.66). In 
      conclusion, results of this analysis of DBRCTs show that the human rotavirus 
      vaccine Rotarix has a reactogenicity and safety profile similar to placebo.
FAU - Buyse, Hubert
AU  - Buyse H
AD  - GlaxoSmithKline Vaccines; Wavre, Belgium.
FAU - Vinals, Carlota
AU  - Vinals C
AD  - GlaxoSmithKline Vaccines; Wavre, Belgium.
FAU - Karkada, Naveen
AU  - Karkada N
AD  - GlaxoSmithKline Vaccines; Bangalore, India.
FAU - Han, Htay Htay
AU  - Han HH
AD  - GlaxoSmithKline Vaccines; King of Prussia, PA USA.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131008
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (RIX4414 vaccine)
RN  - 0 (Rotavirus Vaccines)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Infant
MH  - Male
MH  - Rotavirus Infections/*prevention & control
MH  - Rotavirus Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Survival Analysis
MH  - Vaccination/*adverse effects/*methods
MH  - Vaccines, Attenuated/administration & dosage/adverse effects/immunology
PMC - PMC4181014
OTO - NOTNLM
OT  - Rotarix
OT  - human rotavirus vaccine
OT  - intussusceptions
OT  - reactogenicity
OT  - rotavirus gastroenteritis
OT  - vaccine safety
EDAT- 2013/09/21 06:00
MHDA- 2015/01/06 06:00
PMCR- 2015/01/01
CRDT- 2013/09/20 06:00
PHST- 2013/09/20 06:00 [entrez]
PHST- 2013/09/21 06:00 [pubmed]
PHST- 2015/01/06 06:00 [medline]
PHST- 2015/01/01 00:00 [pmc-release]
AID - 26476 [pii]
AID - 2013HV0257R [pii]
AID - 10.4161/hv.26476 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.