Comparison of Immune Response to Poliovirus and Vibrio cholerae O1 Among Study Groups by Study Visit by Comparing the Proportion Seropositive to Each Antigen
| Study Visit (Day) . | Serotypes . | Children Received Only bOPV [90% CI] . | Children Received Only OCV [90% CI] . | Children Received bOPV + OCV [90% CI] . | Combined bOPV + OCV, bOPV-alone Percent Difference [90% CI] . | Combined bOPV + OCV, OCV-alone Percent Difference [90% CI] . | P- value for Non-inferior Test . |
|---|---|---|---|---|---|---|---|
| Visit 2 (Day 28) | Poliovirus type 1 | 98/179 = 55% [47%, 62%] | … | 106/177 = 60% [53%, 67%] | 5.1% [−3.4%, 13.7%] | … | <.0001 |
| Poliovirus type 2 | 21/179 = 12% [7%, 16%] | … | 31/177 = 18% [12%, 23%] | 5.8% [−.8%, 12.4%] | … | <.0001 | |
| Poliovirus type 3 | 82/179 = 46% [38%, 53%] | … | 95/177 = 54% [46%, 61%] | 7.9% [−.8%, 16.5%] | … | <.0001 | |
| Inaba | … | 89/173 = 51% [44%, 59%] | 109/177 = 62% [54%, 69%] | … | 10.1% [1.5%, 18.8%] | <.0001 | |
| Ogawa | … | 97/173 = 56% [49%, 64%] | 104/177 = 59% [51%, 66%] | … | 2.7% [−5.9%, 11.3%] | .0001 | |
| Visit 3 (Day 56) | Poliovirus type 1 | 21/81 = 26% [16%, 36%] | … | 18/71 = 25% [15%, 36%] | 3.6% [−4.6%, 11.7%] | … | <.0001 |
| Poliovirus type 2 | 15/158 = 9% [5%, 14%] | … | 11/146 = 8% [3%, 12%] | 4.2% [−3.1%, 11.4%] | … | <.0001 | |
| Poliovirus type 3 | 41/97 = 42% [32%, 52%] | … | 36/82 = 44% [33%, 55%] | 6.9% [−1.2%, 15%] | … | <.0001 | |
| Inaba | … | 27/84 = 32% [22%, 42%] | 10/68 = 15% [6%, 23%] | … | −2.5% [−11.1%, 6.1%] | <.0001 | |
| Ogawa | … | 34/76 = 45% [33%, 56%] | 24/73 = 33% [22%, 44%] | … | −3.3% [−11.3%, 4.7%] | .0044 | |
| Cumulative response after 2 doses | Poliovirus type 1 | 119/179 = 66% [59%, 73%] | … | 124/177 = 70% [63%, 77%] | 3.6% [−4.5%, 11.7%] | … | <.0001 |
| Poliovirus type 2 | 36/179 = 20% [14%, 26%] | … | 42/177 = 24% [17%, 30%] | 3.6% [−3.7%, 10.9%] | … | <.0001 | |
| Poliovirus type 3 | 123/179 = 69% [62%, 76%] | … | 131/177 = 74% [67%, 81%] | 5.3% [−2.6%, 13.2%] | … | <.0001 | |
| Inaba | … | 116/173 = 67% [60%, 74%] | 119/177 = 67% [60%, 74%] | … | .2% [−8%, 8.4%] | <.0001 | |
| Ogawa | … | 131/173 = 76% [69%, 82%] | 128/177 = 72% [66%, 79%] | … | −3.4% [−11.1%, 4.3%] | .0054 |
| Study Visit (Day) . | Serotypes . | Children Received Only bOPV [90% CI] . | Children Received Only OCV [90% CI] . | Children Received bOPV + OCV [90% CI] . | Combined bOPV + OCV, bOPV-alone Percent Difference [90% CI] . | Combined bOPV + OCV, OCV-alone Percent Difference [90% CI] . | P- value for Non-inferior Test . |
|---|---|---|---|---|---|---|---|
| Visit 2 (Day 28) | Poliovirus type 1 | 98/179 = 55% [47%, 62%] | … | 106/177 = 60% [53%, 67%] | 5.1% [−3.4%, 13.7%] | … | <.0001 |
| Poliovirus type 2 | 21/179 = 12% [7%, 16%] | … | 31/177 = 18% [12%, 23%] | 5.8% [−.8%, 12.4%] | … | <.0001 | |
| Poliovirus type 3 | 82/179 = 46% [38%, 53%] | … | 95/177 = 54% [46%, 61%] | 7.9% [−.8%, 16.5%] | … | <.0001 | |
| Inaba | … | 89/173 = 51% [44%, 59%] | 109/177 = 62% [54%, 69%] | … | 10.1% [1.5%, 18.8%] | <.0001 | |
| Ogawa | … | 97/173 = 56% [49%, 64%] | 104/177 = 59% [51%, 66%] | … | 2.7% [−5.9%, 11.3%] | .0001 | |
| Visit 3 (Day 56) | Poliovirus type 1 | 21/81 = 26% [16%, 36%] | … | 18/71 = 25% [15%, 36%] | 3.6% [−4.6%, 11.7%] | … | <.0001 |
| Poliovirus type 2 | 15/158 = 9% [5%, 14%] | … | 11/146 = 8% [3%, 12%] | 4.2% [−3.1%, 11.4%] | … | <.0001 | |
| Poliovirus type 3 | 41/97 = 42% [32%, 52%] | … | 36/82 = 44% [33%, 55%] | 6.9% [−1.2%, 15%] | … | <.0001 | |
| Inaba | … | 27/84 = 32% [22%, 42%] | 10/68 = 15% [6%, 23%] | … | −2.5% [−11.1%, 6.1%] | <.0001 | |
| Ogawa | … | 34/76 = 45% [33%, 56%] | 24/73 = 33% [22%, 44%] | … | −3.3% [−11.3%, 4.7%] | .0044 | |
| Cumulative response after 2 doses | Poliovirus type 1 | 119/179 = 66% [59%, 73%] | … | 124/177 = 70% [63%, 77%] | 3.6% [−4.5%, 11.7%] | … | <.0001 |
| Poliovirus type 2 | 36/179 = 20% [14%, 26%] | … | 42/177 = 24% [17%, 30%] | 3.6% [−3.7%, 10.9%] | … | <.0001 | |
| Poliovirus type 3 | 123/179 = 69% [62%, 76%] | … | 131/177 = 74% [67%, 81%] | 5.3% [−2.6%, 13.2%] | … | <.0001 | |
| Inaba | … | 116/173 = 67% [60%, 74%] | 119/177 = 67% [60%, 74%] | … | .2% [−8%, 8.4%] | <.0001 | |
| Ogawa | … | 131/173 = 76% [69%, 82%] | 128/177 = 72% [66%, 79%] | … | −3.4% [−11.1%, 4.3%] | .0054 |
Abbreviations: bivalent oral poliovirus vaccine; CI, confidence interval; OCV, oral cholera vaccine; OPV, oral poliovirus vaccine.
Comparison of Immune Response to Poliovirus and Vibrio cholerae O1 Among Study Groups by Study Visit by Comparing the Proportion Seropositive to Each Antigen
| Study Visit (Day) . | Serotypes . | Children Received Only bOPV [90% CI] . | Children Received Only OCV [90% CI] . | Children Received bOPV + OCV [90% CI] . | Combined bOPV + OCV, bOPV-alone Percent Difference [90% CI] . | Combined bOPV + OCV, OCV-alone Percent Difference [90% CI] . | P- value for Non-inferior Test . |
|---|---|---|---|---|---|---|---|
| Visit 2 (Day 28) | Poliovirus type 1 | 98/179 = 55% [47%, 62%] | … | 106/177 = 60% [53%, 67%] | 5.1% [−3.4%, 13.7%] | … | <.0001 |
| Poliovirus type 2 | 21/179 = 12% [7%, 16%] | … | 31/177 = 18% [12%, 23%] | 5.8% [−.8%, 12.4%] | … | <.0001 | |
| Poliovirus type 3 | 82/179 = 46% [38%, 53%] | … | 95/177 = 54% [46%, 61%] | 7.9% [−.8%, 16.5%] | … | <.0001 | |
| Inaba | … | 89/173 = 51% [44%, 59%] | 109/177 = 62% [54%, 69%] | … | 10.1% [1.5%, 18.8%] | <.0001 | |
| Ogawa | … | 97/173 = 56% [49%, 64%] | 104/177 = 59% [51%, 66%] | … | 2.7% [−5.9%, 11.3%] | .0001 | |
| Visit 3 (Day 56) | Poliovirus type 1 | 21/81 = 26% [16%, 36%] | … | 18/71 = 25% [15%, 36%] | 3.6% [−4.6%, 11.7%] | … | <.0001 |
| Poliovirus type 2 | 15/158 = 9% [5%, 14%] | … | 11/146 = 8% [3%, 12%] | 4.2% [−3.1%, 11.4%] | … | <.0001 | |
| Poliovirus type 3 | 41/97 = 42% [32%, 52%] | … | 36/82 = 44% [33%, 55%] | 6.9% [−1.2%, 15%] | … | <.0001 | |
| Inaba | … | 27/84 = 32% [22%, 42%] | 10/68 = 15% [6%, 23%] | … | −2.5% [−11.1%, 6.1%] | <.0001 | |
| Ogawa | … | 34/76 = 45% [33%, 56%] | 24/73 = 33% [22%, 44%] | … | −3.3% [−11.3%, 4.7%] | .0044 | |
| Cumulative response after 2 doses | Poliovirus type 1 | 119/179 = 66% [59%, 73%] | … | 124/177 = 70% [63%, 77%] | 3.6% [−4.5%, 11.7%] | … | <.0001 |
| Poliovirus type 2 | 36/179 = 20% [14%, 26%] | … | 42/177 = 24% [17%, 30%] | 3.6% [−3.7%, 10.9%] | … | <.0001 | |
| Poliovirus type 3 | 123/179 = 69% [62%, 76%] | … | 131/177 = 74% [67%, 81%] | 5.3% [−2.6%, 13.2%] | … | <.0001 | |
| Inaba | … | 116/173 = 67% [60%, 74%] | 119/177 = 67% [60%, 74%] | … | .2% [−8%, 8.4%] | <.0001 | |
| Ogawa | … | 131/173 = 76% [69%, 82%] | 128/177 = 72% [66%, 79%] | … | −3.4% [−11.1%, 4.3%] | .0054 |
| Study Visit (Day) . | Serotypes . | Children Received Only bOPV [90% CI] . | Children Received Only OCV [90% CI] . | Children Received bOPV + OCV [90% CI] . | Combined bOPV + OCV, bOPV-alone Percent Difference [90% CI] . | Combined bOPV + OCV, OCV-alone Percent Difference [90% CI] . | P- value for Non-inferior Test . |
|---|---|---|---|---|---|---|---|
| Visit 2 (Day 28) | Poliovirus type 1 | 98/179 = 55% [47%, 62%] | … | 106/177 = 60% [53%, 67%] | 5.1% [−3.4%, 13.7%] | … | <.0001 |
| Poliovirus type 2 | 21/179 = 12% [7%, 16%] | … | 31/177 = 18% [12%, 23%] | 5.8% [−.8%, 12.4%] | … | <.0001 | |
| Poliovirus type 3 | 82/179 = 46% [38%, 53%] | … | 95/177 = 54% [46%, 61%] | 7.9% [−.8%, 16.5%] | … | <.0001 | |
| Inaba | … | 89/173 = 51% [44%, 59%] | 109/177 = 62% [54%, 69%] | … | 10.1% [1.5%, 18.8%] | <.0001 | |
| Ogawa | … | 97/173 = 56% [49%, 64%] | 104/177 = 59% [51%, 66%] | … | 2.7% [−5.9%, 11.3%] | .0001 | |
| Visit 3 (Day 56) | Poliovirus type 1 | 21/81 = 26% [16%, 36%] | … | 18/71 = 25% [15%, 36%] | 3.6% [−4.6%, 11.7%] | … | <.0001 |
| Poliovirus type 2 | 15/158 = 9% [5%, 14%] | … | 11/146 = 8% [3%, 12%] | 4.2% [−3.1%, 11.4%] | … | <.0001 | |
| Poliovirus type 3 | 41/97 = 42% [32%, 52%] | … | 36/82 = 44% [33%, 55%] | 6.9% [−1.2%, 15%] | … | <.0001 | |
| Inaba | … | 27/84 = 32% [22%, 42%] | 10/68 = 15% [6%, 23%] | … | −2.5% [−11.1%, 6.1%] | <.0001 | |
| Ogawa | … | 34/76 = 45% [33%, 56%] | 24/73 = 33% [22%, 44%] | … | −3.3% [−11.3%, 4.7%] | .0044 | |
| Cumulative response after 2 doses | Poliovirus type 1 | 119/179 = 66% [59%, 73%] | … | 124/177 = 70% [63%, 77%] | 3.6% [−4.5%, 11.7%] | … | <.0001 |
| Poliovirus type 2 | 36/179 = 20% [14%, 26%] | … | 42/177 = 24% [17%, 30%] | 3.6% [−3.7%, 10.9%] | … | <.0001 | |
| Poliovirus type 3 | 123/179 = 69% [62%, 76%] | … | 131/177 = 74% [67%, 81%] | 5.3% [−2.6%, 13.2%] | … | <.0001 | |
| Inaba | … | 116/173 = 67% [60%, 74%] | 119/177 = 67% [60%, 74%] | … | .2% [−8%, 8.4%] | <.0001 | |
| Ogawa | … | 131/173 = 76% [69%, 82%] | 128/177 = 72% [66%, 79%] | … | −3.4% [−11.1%, 4.3%] | .0054 |
Abbreviations: bivalent oral poliovirus vaccine; CI, confidence interval; OCV, oral cholera vaccine; OPV, oral poliovirus vaccine.
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