Immunogenicity, reactogenicity, and safety of a human rotavirus vaccine, Rotarix, in Taiwanese infants who received a dose of hepatitis B immunoglobulin after birth.
This Phase-IV study evaluated the human rotavirus (RV) vaccine Rotarix (RIX4414) to provide additional local clinical data to the Taiwan Food and Drug Association (NCT01198769). Healthy infants aged 6-12 weeks who were given a hepatitis B immunoglobulin (HBIg) dose after birth, received two doses of RIX4414 (0, 2-month schedule). Anti-RV IgA antibody concentrations were measured using ELISA. A total of 15 infants were enrolled, and included in the according-to-protocol cohort. The anti-RV IgA antibody seroconversion rate 2 months post-Dose 2 was 100% (95% confidence interval = 78.2-100) and the geometric mean concentration was 254.7 U/ml (95% confidence interval = 145.0-447.7). Two episodes of gastroenteritis were reported, and one stool sample was tested for RV, which was negative. No fatal serious adverse events were reported during the study period between November 2010 and April 2011. The two-dose regimen of RIX4414 was highly immunogenic and safe when administered to healthy Taiwanese infants who received a HBIg dose after birth.


BACKGROUND
NCT01198769.
Department of Pediatrics, National Taiwan University Hospital, Taipei 100, Taiwan.
Chun-Yi
CY
Lu
Luan-Yin
LY
Chang
Pei-Lan
PL
Shao
Pemmaraju Venkata
PV
Suryakiran
Htay-Htay
HH
Han
Li-Min
LM
Huang
D000914:Antibodies, Viral / Q000097:blood; D006801:Humans; D007136:Immunoglobulins / Q000276:immunology*; D007223:Infant; D012401:Rotavirus / Q000276:immunology*; D022243:Rotavirus Vaccines / Q000009:adverse effects / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; D007136:Immunoglobulins; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated; C045213:hepatitis B hyperimmune globulin
Taiwan; hepatitis B envelope antigen; hepatitis B immunoglobulin; hepatitis B surface antigen; rotavirus