Open-Label Pilot Study to Compare the Safety and Immunogenicity of Pentavalent Rotavirus Vaccine (RV5) Administered on an Early Alternative Dosing Schedule with Those of RV5 Administered on the Recommended Standard Schedule.
This study compares the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) administered on an alternative schedule (initiated at 2-5 weeks of age) with those of RV5 administered on the recommended standard schedule. Our findings support the future conduct of larger clinical trials to confirm the safety and efficacy of rotavirus vaccination in the neonatal period.
Department of Pediatrics, Division of Pediatric Infectious Diseases, Duke Clinical Vaccine Unit, Duke University School of Medicine, Durham, North Carolina.
Ezzeldin
E
Saleh
Department of Pediatrics, Durham, North Carolina.
Brian
B
Eichner
Department of Pediatrics, Durham, North Carolina.
Douglas W
DW
Clark
Department of Pediatrics, Durham, North Carolina.
Martha E
ME
Gagliano
Department of Pediatrics, Durham, North Carolina.
James M
JM
Troutman
Duke Clinical Vaccine Unit, Duke University Medical Center, Durham, North Carolina.
Lynn
L
Harrington
Department of Pediatrics, Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Ohio.
Monica
M
McNeal
Department of Pediatrics, Division of Pediatric Infectious Diseases, Duke Global Health Institute, Duke Clinical Vaccine Unit, Duke University School of Medicine, Durham, North Carolina.
Dennis
D
Clements
D000367:Age Factors; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010865:Pilot Projects; D012401:Rotavirus / Q000276:immunology; D012400:Rotavirus Infections / Q000276:immunology / Q000517:prevention & control; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use
C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated