Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine.
BACKGROUND
Rotavirus is a leading cause of childhood gastroenteritis and death worldwide.


METHODS
We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events.


RESULTS
The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1-G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1-G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1-G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent).


CONCLUSIONS
This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.)
Vesikari
Timo
T
University of Tampere Medical School, Tampere, Finland.
Matson
David O
DO
Dennehy
Penelope
P
Van Damme
Pierre
P
Santosham
Mathuram
M
Rodriguez
Zoe
Z
Dallas
Michael J
MJ
Heyse
Joseph F
JF
Goveia
Michelle G
MG
Black
Steven B
SB
Shinefield
Henry R
HR
Christie
Celia D C
CD
Ylitalo
Samuli
S
Itzler
Robbin F
RF
Coia
Michele L
ML
Onorato
Matthew T
MT
Adeyi
Ben A
BA
Marshall
Gary S
GS
Gothefors
Leif
L
Campens
Dirk
D
Karvonen
Aino
A
Watt
James P
JP
O'Brien
Katherine L
KL
DiNubile
Mark J
MJ
Clark
H Fred
HF
Boslego
John W
JW
Offit
Paul A
PA
Heaton
Penny M
PM
D000284:Administration, Oral; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D002417:Cattle; D003968:Diarrhea, Infantile / Q000517:prevention & control / Q000821:virology; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000209:etiology; D005759:Gastroenteritis / Q000517:prevention & control* / Q000821:virology; D006471:Gastrointestinal Hemorrhage / Q000209:etiology; D006295:Health Resources / Q000706:statistics & numerical data; D006760:Hospitalization; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D007443:Intussusception / Q000209:etiology*; D008297:Male; D016865:Reassortant Viruses; D012306:Risk; D012401:Rotavirus / Q000145:classification / Q000276:immunology; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; D007070:Immunoglobulin A; C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated