Evaluation of RIX4414, A Live, Attenuated Rotavirus Vaccine, in a Randomized, Double‐Blind, Placebo‐Controlled Phase 2 Trial Involving 2464 Singaporean Infants

Abstract

The live, attenuated rotavirus vaccine (RIX4414) was well tolerated and highly immunogenic in Singaporean infants. The immunogenicity of routinely administered infant vaccines was not impaired by concomitant administration of RIX4414 vaccine.

Safety of Rotavirus Vaccine in the NICU

“…17 Transmission of rotavirus vaccine strain RV1 to unvaccinated individuals has been assessed in many studies [18][19][20][21][22][23][24][25] but only documented as occurring in 3. [18][19][20] In studies documenting RV1 transmission, seroconversion varied from 2% to 6% among placebo recipients. A recent study evaluated the potential for transmission of RV1 from a vaccine recipient to an unvaccinated twin sibling among 80 twin pairs.…”

Rotavirus vaccines: Opportunities and challenges

“…Employing different detection methodologies to that used for identifying viral shedding by PRV, researchers found by using serial antigen tests 70-80% of Singaporean infants shed virus 7 days post-immunization and 25% still had positive antigen tests 3 weeks later (ROTA 007). 113 In this study three cases of virus transmission were detected in 50 placebo recipients without known contact with vaccine recipients, two underwent IgA seroconversion and none developed symptoms. Two twins with siblings receiving HRV also shed the vaccine strain and underwent seroconversion.…”

“…9,111 The HRV strain replicates well in the gut, is immunogenic (anti-rotavirus IgA seroconversion rates of 73-96%) and is commonly shed in stools. 2,112,113 At least six major randomized double-blind, placebo controlled trials have been conducted with HRV to evaluate its safety and efficacy (Table 4). The largest (ROTA 023) recruited more than 63,000 infants, principally from 11 countries in Latin America and from Finland.…”

Prevention of Rotavirus Disease: Updated Guidelines for Use of Rotavirus Vaccine

“…6,8,18 For RV1, no difference versus placebo was observed in the incidence of diarrhea, fever or severe fever, vomiting or severe vomiting, and irritability or severe irritability within 14 days of immunization with any dose. 9,10,13,15 There was no statistically significant increased risk for death or other serious adverse events noted with either vaccine compared with placebo. Human strain 89-12 Composition Five human-bovine reassortant strains Single human strain RIX4414 G and P types G1P͓5͔ G1P͓8͔ G2P͓5͔ G3P͓5͔ G4P͓5͔ G6P͓8͔ Labeled indication Immunization against rotavirus gastroenteritis caused by G1, G2, G3, and G4 Immunization against rotavirus gastroenteritis caused by G1, G3, G4, and G9 Labeled age of administration, wk 6 through 32 11 Although neither RV5 nor RV1 has been associated with intussusception in large prelicensure trials, rigorous postlicensure monitoring for safety end points is necessary because of possible differences in the characteristics of infants receiving the vaccine in routine use compared with the clinical trials and the large numbers of infants being immunized.…”

“…The rate of transmission is unknown, but no known cases have developed symptoms of rotavirus gastroenteritis. 10 …”