BioCentury
ARTICLE | Clinical News

RTS: Additional Phase III data

November 12, 2012 8:00 AM UTC

Data from the per protocol (PP) population of 6,003 infants aged 6-12 weeks who received all 3 doses of RTS,S in a double-blind, African Phase III trial showed that the vaccine significantly reduced the incidence of clinical malaria, a co-primary endpoint, over a 12-month period following vaccination by 31.3% compared to the non-malaria comparator vaccine group (p<0.001). In the PP population, the vaccine also significantly reduced the incidence of severe malaria, a co-primary endpoint, over a 12-month period following vaccination by 36.6% compared to the non-malaria comparator vaccine group (p=0.02). In the intent-to-treat (ITT) population (n=6,537), the vaccine reduced the incidence of clinical malaria by 30.1% (p<0.001) and severe malaria by 26% (p=0.09) vs. control. The frequency of serious adverse events was similar between treatment groups. The trial has enrolled 15,460 children in 2 age categories - 6-12 weeks of age and 5-17 months of age - to receive a non-malaria comparator vaccine or 3 doses of RTS,S given at 1-month intervals with or without a booster dose given 18 months after the third dose. Data were published in the New England Journal of Medicine.

Last year, data from 6,000 evaluable children in the older age cohort showed that RTS,S significantly reduced the incidence of clinical malaria by 55.8% and severe malaria by 47.3% over a 12-month period vs. the non-malaria comparator vaccine group (p<0.001 for both) (see BioCentury, Oct. 24, 2011). Comparator vaccines in the study were the Verorab rabies vaccine from Sanofi (Euronext:SAN; NYSE:SNY, Paris, France) for children 5-17 months of age at enrollment and the Menjugate meningococcus C conjugate vaccine from Novartis AG (NYSE:NVS; SIX:NOVN, Basel, Switzerland) for children 6-12 weeks of age at enrollment. Long-term efficacy data from a 30-month follow-up are expected by year end 2014. ...