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Faculty of Health Sciences
School of Medicine
Department of Paediatrics
Human Rotavirus Vaccine (Rotarix)
A Phase II Double Blind Randomised Placebo Controlled Study to Assess the Safety Reactogenicity and Immunogenic of Three doses of GaxoSmithKline (GSK) Biological Oral Live Attenuated Human Rotavirus (HRV) Vaccine (RIX4414 fat 10(6.5) CCID50) Administered to Human Immunodeficiency Virus (HOV) infected infants at 6, 10 and 14 weeks of age in South Africa Primary objectives: To assess the safety and reactogenicity of 3 doses of GSK Biologicals' HRV vaccine versus placebo in HIV infected infants. Secondary objectives: To assess the immunogenicity (GMC, seroconversion, vaccine intake) of the HRV vaccine in HIV infected infants two months after the third dose; To assess rotavirus shedding in HIV infected infants; To assess enteric pathogens in diarrheal stools; To assess the immune deficiency condition (HIV viral load and CD4 counts); To assess the immunogenicity of routine vaccines (DTPw-HBV/HIB+ OPV) two months after the third dose
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