Table 3.
Age and seropositivity rates at pre-dose-1 and post-last-dose time points in the placebo groups (of the Total vaccinated cohort)
| Region | Countries | Study number | Mean age at pre-dose-1 (weeks) ± SD | Seropositivity rate at pre-dose-1 | Mean age at last-dose of placebo (weeks) ± SD | Time between last-dose of placebo and post-last-dose blood draw (weeks) | Seropositivity rate post-last-dose |
|---|---|---|---|---|---|---|---|
| % (n/N) | |||||||
| % (n/N) | |||||||
| Africa | South Africa | 444563/013 (Rota-013) | 6.4 ± 1.07 | 4.3 (4/94) | 15.0 ± 2.32 | 8 | 6.3 (5/80) |
| South Africa | 444563/022 (Rota-022) | 6.9 ± 1.02 | 13.0 (6/46) | 14.9 ± 1.64 | 8 | 29.4 (10/34) | |
| South Africa, Malawi | 102248 (Rota-037) | 6.4 ± 0.97 | 11.5 (18/157) | 16.3 ± 1.51 | 4 | 25.2 (348/1380) | |
| Asia | Korea | 103478 (Rota-041) | 10.5 ± 0.92 | 23.1 (12/52) | 19.4 ± 1.09 | 8 | 20.4 (10/49) |
| India | 103792 (Rota-044) | 8.6 ± 0.69 | 26.3 (45/171) | 13.5 ± 1.12 | 4 | 26.2 (43/164) | |
| Bangladesh | 103992 (Rota-045) | 12.2 ± 0.47 | 15.2 (14/92) | 16.8 ± 0.52 | 4 | 34.8 (32/92) | |
| Singapore, Hong Kong, Taiwan | 444563 (Rota-028, −029, −030) | 11.6 ± 2.37 | 0.7 (1/135) | 17.8 ± 1.55 | 4–8 | 1.5 (2/132) | |
| Latin America | Brazil, Mexico and Venezuela | 444563/006 (Rota 006) | 8.6 ± 1.98 | 2.1 (11/528) | NA* | 8 | 13.2 (24/182) |
| Argentina, Brazil, Chile, Colombia, Dominican Republic, Honduras, Mexico, Nicaragua, Panama, Peru and Venezuela | 444563/023 (Rota 023) | 8.4 ± 2.37 | 3.5 (15/432) | 16.3 ± 3.77 | 4–8 | 15.1 (60/398) | |
| Mexico, Colombia, Peru | 444563/033 (Rota-033) | 8.6 ± 2.20 | 3.3 (4/121) | NA* | 8 | 13.1 (14/107) | |
| Dominican Republic | 106260 (Rota-052) | 8.2 ± 1.80 | 9.3 (9/97) | 14.2 ± 1.83 | 6 | 30.2 (29/96) | |
| Europe | Finland | 444563/003 (Rota 003) | 7.6 ± 1.75 | 0.0 (0/16) | NA* | 4 | 0.0 (0/14) |
| Finland | 104480 (Rota-048) | 9.3 ± 2.04 | 0.0 (0/49) | 14.4 ± 2.12 | 4 | 0.0 (0/48) | |
| Finland, Czech Republic, France, Germany, Italy, Spain | 102247 (Rota-036) | 11.4 ± 1.84 | 2.1 (10/479) | 19.6 ± 2.74 | 12 | 9.5 (45/473) | |
| France, Portugal, Poland and Spain | 106481 (Rota-054) | 8.5 ± 1.78 | 9.4 (9/96) | 16.0 ± 2.95 | 4 | 21.3 (20/94) | |
| North America | United States and Canada | 444563/005 (Rota 005) | 8.6 ± 1.31 | 0.0 (0/95) | NA* | 8 | 9.3 (8/86) |
SD = Standard deviation.
n = number of infants in placebo groups with anti-rotavirus IgA antibody concentration ≥20 U/ml.
N = number of infants in placebo groups with available results.
Note: In all the studies mentioned above, the assessment of seropositivity rates was performed on a subset of total number of enrolled infants.
NA* = No age data calculated for the post-last-dose time point.