Rotasiil-Liquid Adverse Reactions

In the phase III trial of ROTASIIL, no differences were detected between ROTASIIL and placebo groups in the post vaccination rates of solicited adverse events within 7 days of each dose of vaccine. Similarly, in the phase III trial of ROTASIIL-Liquid, no differences were detected between ROTASIIL-Liquid and ROTASIIL groups in the post-vaccination rates of solicited adverse events within 7 days of each dose of vaccine. These events in decreasing order of frequency were: Fever (64.6% in ROTASIIL-Liquid group and 64.6% in ROTASIIL group), irritability (51.5% in ROTASIIL-Liquid group and 50.5% in ROTASIIL group), decreased appetite (31.9% in ROTASIIL-Liquid group and 31.6 % in ROTASIIL group), decreased activity level (23.2% in ROTASIIL-Liquid group and 22.3% in ROTASIIL group), vomiting (17.9% in ROTASIIL-Liquid group and 13.8 % in ROTASIIL group) and diarrhea (12.1% in ROTASIIL-Liquid group and 13.8% in ROTASIIL group). The incidence of all solicited events was similar in ROTASIIL-Liquid and ROTASIIL groups. Most of these events were of short duration and predominately mild (74% of episodes) in severity. It should be noted that in the phase 3 study, ROTASIIL-Liquid and ROTASIIL were administered to all children concomitantly with DTwP vaccine, which is known to cause a level of reactogenicity similar to that observed in this study.
The occurrence of unsolicited adverse events was monitored throughout the phase 3 trial and the incidence was similar in both the groups. The most frequent serious adverse events (SAE) observed included bronchiolitis, lower respiratory tract infection and gastroenteritis. Only one SAE of gastroenteritis that occurred within 7 days post-vaccination in ROTASIIL group was considered to be causally related.
No death as well as intussusception case was reported in this study.
Further, in Phase III trial of ROTASIIL, total thirteen cases of intussusception were diagnosed; 6 occurred in the ROTASIIL arm and 7 in the placebo arm. None occurred within 28 days of receiving a dose of ROTASIIL or placebo. None were related to study vaccination or led to discontinuations from the study.