PMID- 19209095
OWN - NLM
STAT- MEDLINE
DCOM- 20090403
LR  - 20091119
IS  - 0891-3668 (Print)
IS  - 0891-3668 (Linking)
VI  - 28
IP  - 3
DP  - 2009 Mar
TI  - The human rotavirus vaccine RIX4414 in infants: a review of safety and 
      tolerability.
PG  - 225-32
LID - 10.1097/INF.0b013e31819715fa [doi]
AB  - BACKGROUND: An oral, live attenuated human rotavirus vaccine, RIX4414 has been 
      developed to prevent rotavirus gastroenteritis. An integrated safety summary of 8 
      randomized, placebo-controlled, double-blind phase II and III trials of vaccine 
      at potency licensed for use worldwide was performed. METHODS: Healthy 1- to 
      18-week-old infants (N = 71209) were enrolled to receive 2 doses of 
      RIX4414/placebo according to 0, 1 or 0, 2 month schedules. Solicited (fever, 
      fussiness/irritability, loss of appetite, vomiting, diarrhea, cough/rhinorrhea) 
      and unsolicited adverse events (AEs) were recorded for 8 days and 31 days, 
      respectively, after each dose. Serious adverse events (SAEs) including 
      intussusception and death were collected throughout the entire study periods. 
      Potential imbalances were defined as the 95% confidence interval (CI) for the 
      relative risk (RR) stratified by trials excluding "1." RESULTS: Solicited AEs 
      were evaluated in 3286 RIX4414 vaccinees and 2015 placebo recipients. Among 
      solicited AEs, no imbalance was noted between groups. SAEs, including death and 
      intussusception, were evaluated in 36755 RIX4414 and 34454 placebo recipients. 
      Within 31 days after each dose, no imbalances were noted between the groups for 
      all SAEs (RR = 0.9; 95% CI: 0.81, 1.01), deaths (RR = 1.64; 95% CI: 0.92, 3.02), 
      and intussusception (RR 1.23; 95% CI: 0.41, 3.90). SAEs because of 
      gastrointestinal diseases including diarrhea, gastroenteritis (all cause and due 
      to rotavirus), dehydration, and intestinal ileus occurred significantly less 
      often in RIX4414 than placebo recipients. CONCLUSIONS: Across the phase II and 
      III clinical trials, the reactogenicity and safety profile between RIX4414 and 
      placebo was similar, in particular with no increased risk of intussusception.
FAU - Cheuvart, Brigitte
AU  - Cheuvart B
AD  - GlaxoSmithKline Biologicals, Rixensart, Belgium. brigitte.cheuvart@gskbio.com
FAU - Friedland, Leonard R
AU  - Friedland LR
FAU - Abu-Elyazeed, Remon
AU  - Abu-Elyazeed R
FAU - Han, Htay Htay
AU  - Han HH
FAU - Guerra, Yolanda
AU  - Guerra Y
FAU - Verstraeten, Thomas
AU  - Verstraeten T
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (RIX4414 vaccine)
RN  - 0 (Rotavirus Vaccines)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Clinical Trials, Phase II as Topic
MH  - Clinical Trials, Phase III as Topic
MH  - *Gastrointestinal Diseases/immunology/prevention & control/virology
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - *Intussusception/etiology/prevention & control
MH  - Randomized Controlled Trials as Topic
MH  - Rotavirus/*immunology
MH  - *Rotavirus Infections/immunology/prevention & control/virology
MH  - Rotavirus Vaccines
MH  - Treatment Outcome
MH  - Vaccines, Attenuated/administration & dosage/*adverse effects/therapeutic use
RF  - 14
EDAT- 2009/02/12 09:00
MHDA- 2009/04/04 09:00
CRDT- 2009/02/12 09:00
PHST- 2009/02/12 09:00 [entrez]
PHST- 2009/02/12 09:00 [pubmed]
PHST- 2009/04/04 09:00 [medline]
AID - 10.1097/INF.0b013e31819715fa [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2009 Mar;28(3):225-32. doi: 10.1097/INF.0b013e31819715fa.