This is a dose exploration Phase 2 study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (529 infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations.
The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.
All subjects enrolled from the Eastern United States and Eastern Canada will continue their participation in the pilot efficacy follow-up (pilot efficacy subset).
The third dose of IPV vaccine (IPOL) may be given at visits 3, 4, or another time, at the investigator's discretion.
Comvax may be given in place of OmniHIB/ActHIB at Visit 1 and Visit 2 and the third dose of Comvax administered according to the prescribing information.
The Pediatric Infectious Disease Journal published the results of this trial on June 24, 2005.
Results: No serious adverse events considered related to vaccines were reported. The incidence of solicited symptoms was similar among treatment groups during the 15-day postvaccination surveillance periods.
No significant difference in vaccine taken after 2 doses (88.0% in high dose group and 81.5% in low dose group) was seen between vaccine groups (P = 0.153).
Conclusions: Two doses of either dosage level of HRV vaccine administered concurrently with routine childhood vaccines to healthy infants 5-15 weeks of age were well-tolerated and were highly immunogenic.