PCV7 444 | PHiD-CV10 451 | Absolute risk difference [95%CI] | P value | |||
---|---|---|---|---|---|---|
n | % | n | % | |||
No. children without assessment | 12 | 3% | 14 | 3% | ||
No. children with diagnosis based on tympanometry alone | 4 | 1% | 0 | 0% | ||
No. children with unilateral otoscopy | 27 | 6% | 13 | 3% | ||
No. children with bilateral otoscopy | 401 | 90% | 424 | 94% | ||
No. children with at least one ear successfully assessed | 432 | 97% | 437 | 97% | ||
Clinical diagnosis | PCV7 432 | PHiD-CV10 437 | ||||
normal | 32 | 7% | 41 | 9% | 2% [−1 to 6] | 0.29 |
OME | 175 | 41% | 222 | 51% | 10% [3-17] | 0.002 |
AOMwoP | 150 | 35% | 111 | 25% | −9% [−15 to −3] | 0.003 |
AOMwiP | 27 | 6% | 24 | 5% | −1% [−4 to 2] | 0.63 |
Dry Perforation | 8 | 2% | 5 | 1% | −0.7% [−2 to 1] | 0.39 |
CSOM | 40 | 9% | 34 | 8% | −1% [−5 to 2] | 0.43 |
Bilateral OME* | 136/401 | 34% | 191/424 | 45% | 11% [4-17] | 0.001 |
Unilateral OME* | 24/401 | 6% | 25/424 | 6% | 0.1% [−3 to 3] | 1.000 |
Combination OM categories | ||||||
Any suppurative OM (AOMwoP, AOMwiP, CSOM) | 217 | 51% | 169 | 39% | −12% [−19 to −5] | 0.0004 |
Any TMP (AOMwiP, DP, CSOM) | 75 | 17% | 63 | 14% | −3% [−8 to 2] | 0.24 |
Any ear pain (today or last night) | 34/408 | 8% | 17/337 | 5% | −3% [−7 to 0.2] | 0.08 |
Non-mixed PCV schedules | PCV7-only 353** | PHiD-CV10-only 319 | ||||
No. children with at least one ear successfully assessed | 345 | 98% | 309 | 97% | ||
Normal | 24 | 7% | 31 | 10% | 3% [−1 to 7] | 0.16 |
OME | 127 | 37% | 152 | 49% | 12% [5 to 20] | 0.001 |
Any suppurative OM (AOMwoP, AOMwiP, CSOM) | 191 | 56% | 121 | 40% | −16% [−24 to −8] | <0.0001 |
Any TMP (AOMwiP, DP, CSOM) | 62 | 18% | 48 | 16% | −2% [−8 to 3] | 0.40 |