A study to compare the safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants.

The primary hypothesis of the study is that the new formulation will be non-inferior to the existing formulation on the basis of immunogenicity.

1020 6 weeks to 12 weeks children will be enrolled in the study.

Results

The modified formulation of RV5 (RV5mp) group (n = 505) and RV5 group (n = 509) had comparable safety profiles. There were no deaths and no vaccine-related serious adverse events in this study. With respect to immunogenicity, RV5mp was non-inferior compared with RV5. Serum neutralizing antibody responses by country and breastfeeding status was generally consistent with the overall results.

Conclusions

RV5mp enhances storage requirements while maintaining the immunogenicity and safety profile of the currently licensed RV5. A vaccine that is stable at room temperature may be more convenient for vaccinators, particularly in places where the cold chain is unreliable, and ultimately will permit more widespread use.