Efficacy and safety of pentavalent human-bovine reassortant rotavirus vaccine when administered with greater than 10 weeks between doses.
The pentavalent human-bovine reassortant rotavirus vaccine is indicated as a 3-dose series with first dose administered orally at 6 to 12 weeks with subsequent doses at 4 to 10 week intervals. In pre-licensure phase III trials, the majority followed this schedule, but there were 2956 instances where infants received a dose of pentavalent human-bovine reassortant rotavirus vaccine/placebo >10 weeks after the previous dose. Among this subset, the efficacy against any severity of disease, the reduction in utilization of healthcare resources and the safety profile after vaccination were comparable with overall results.
Goveia
Michelle G
MG
Merck & Co., Inc. West Point, PA 19486, USA. michelle_goveia@merck.com
Suprun
Leora
L
Itzler
Robbin F
RF
McFetridge
Richard
R
Dallas
Michael J
MJ
Kuter
Barbara J
BJ
D005260:Female; D006268:Health Facilities / Q000706:statistics & numerical data; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods*; D007223:Infant; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D016865:Reassortant Viruses / Q000276:immunology; D012401:Rotavirus / Q000276:immunology; D012400:Rotavirus Infections / Q000473:pathology / Q000517:prevention & control; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014611:Vaccination / Q000379:methods*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D010919:Placebos; C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated