Table 2.

Summary of Results for the Coprimary Objectives, Evaluated at 1–2 Months After the Second Vaccine Dose (Per-Protocol Set)

Group	n	GMC/SC Rate	Assessed Outcome	Value (95% CI)
Lot-to-lot consistency between PCV-free HRV lots
PCV-free Lot A HRV	332	156.1 U/mL	Lot A/Lot B GMC ratio	1.07 (.79–1.44)
PCV-free Lot B HRV	326	145.9 U/mL	Lot A/Lot C GMC ratio	0.88 (.65–1.19)
PCV-free Lot C HRV	326	177.1 U/mL	Lot B/Lot C GMC ratio	0.82 (.61–1.11)
Noninferiority of PCV-free HRV compared to HRV in terms of SC rates
Pooled PCV-free   HRV	984	79.27%	Difference in SC rate (pooled PCV-free HRV–HRV)	−2.49 (−7.15 to 2.63)
HRV	329	81.76%
Noninferiority of PCV-free HRV compared to HRV in terms of GMCs
Pooled PCV-free HRV	984	159.5 U/mL	GMC ratio (pooled PCV-free HRV/HRV)	1.04 (.82–1.33)
HRV	329	152.8 U/mL

The adjusted GMC ratio was computed with an ANOVA model including the vaccine group (lot A, lot B, and lot C) and the country as fixed effects.

The seroconversion rate was defined as the percentage of infants who were initially seronegative (ie, with anti-RV IgA antibody concentration <20 U/mL prior the first dose) and developed anti-RV IgA antibody concentration ≥20 U/mL after the second dose.

Bolded values indicate that the lot-to-to consistency or noninferiority criteria were met.

Abbreviations: CI, confidence interval; GMC, geometric mean concentration estimated from the ANOVA model; HRV, human rotavirus vaccine licensed at the time of study conduct; n, number of infants with available results; PCV-free Lot A HRV, PCV-free lot B HRV, PCV-free Lot C HRV, lots A, B, and C of the porcine circovirus-free HRV; Pooled PCV-free, porcine circovirus-free HRV liquid formulation of pooled lot A/B/C groups; SC, seroconversion.