Co-administration study in South African infants of a live-attenuated oral human rotavirus vaccine (RIX4414) and poliovirus vaccines.
作者： A.D. Steele , B. De Vos , J. Tumbo , J. Reynders , F. Scholtz
DOI: 10.1016/J.VACCINE.2008.08.034
关键词:
摘要: A double-blind, placebo-controlled phase II trial (e-Track 444563-014/NCT00346892) was conducted in South Africa to evaluate the co-administration of RIX4414 (live-attenuated human G1P[8] rotavirus vaccine) and oral poliovirus vaccine (OPV) administered simultaneously. Healthy infants (n=450) were randomized into three groups (RIX4414+OPV, RIX4414+IPV or Placebo+OPV) receive two doses RIX4414/placebo with OPV IPV using vaccination schedules (6-10 weeks 10-14 weeks). Serum anti-rotavirus IgA antibodies (ELISA) neutralizing (micro-neutralization assay) serotypes 1, 2 3 measured. Co-administration did not result a decrease high sero-protection rates against detected after third dose (98-100%). The antibody sero-conversion higher for schedule (55-61%) compared 6-10 (36-43%). Solicited symptoms reported at similar between placebo no serious adverse events related reported. This study provided evidence that can be co-administered routine EPI immunizations including well tolerated immunogenic African infants.
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