Table 2.
Occurrence of AOM episodes in the intent-to-treat and per-protocol analyses.
| First AOM episodes, number (%) |
All AOM episodes,a number (%) |
|||||||
|---|---|---|---|---|---|---|---|---|
| Intent-to-treat analysis |
Per-protocol analysis |
Intent-to-treat analysis |
Per-protocol analysis |
|||||
| Case definition | PHiD-CV group (N = 3,602) | Control group (N = 3,612) | PHiD-CV group (N = 3,010) | Control group (N = 2,979) | PHiD-CV group (N = 3,602) | Control group (N = 3,612) | PHiD-CV group (N = 3,010) | Control group (N = 2,979) |
| C-AOM | 254 (7.1) | 308 (8.5) | 204 (6.8) | 239 (8.0) | 294 (8.2) | 343 (9.5) | 226 (7.5) | 257 (8.6) |
| B-AOM | 45 (1.3) | 67 (1.9) | 32 (1.1) | 45 (1.5) | 47 (1.3) | 70 (1.9) | 32 (1.1) | 46 (1.5) |
| Pneumococcal C-AOM | 17 (0.5) | 38 (1.1) | 12 (0.4) | 27 (0.9) | 18 (0.5) | 38 (1.1) | 12 (0.4) | 27 (0.9) |
| Vaccine serotype C-AOM | 7 (0.2) | 23 (0.6) | 6 (0.2) | 18 (0.6) | 7 (0.2) | 23 (0.6) | 6 (0.2) | 18 (0.6) |
| Vaccine-related serotypesb | 5 (0.1) | 7 (0.2) | 3 (0.1) | 4 (0.1) | 5 (0.1) | 7 (0.2) | 3 (0.1) | 4 (0.1) |
| Other serotype C-AOM | 6 (0.2) | 7 (0.2) | 3 (0.1) | 4 (0.1) | 6 (0.2) | 7 (0.2) | 3 (0.1) | 4 (0.1) |
| H. influenzae C-AOM | 20 (0.6) | 24 (0.7) | 12 (0.4) | 14 (0.5) | 20 (0.6) | 25 (0.7) | 12 (0.4) | 14 (0.5) |
| NTHi C-AOM | 19 (0.5) | 24 (0.7) | 12 (0.4) | 14 (0.5) | 19 (0.5) | 25 (0.7) | 12 (0.4) | 14 (0.5) |
| Staphylococcus aureusc | 3 (0.1) | 6 (0.2) | 2 (0.1) | 3 (0.1) | 3 (0.1) | 6 (0.2) | 2 (0.1) | 3 (0.1) |
| Group A streptococcus | 4 (0.1) | 4 (0.1) | 4 (0.1) | 4 (0.1) | 4 (0.1) | 4 (0.1) | 4 (0.1) | 4 (0.1) |
| Moraxella catarrhalis | 2 (0.1) | 0 (0) | 1 (0.0) | 0 (0) | 2 (0.1) | 0 (0) | 1 (0.0) | 0 (0) |
All AOM episodes, including multiple episodes in the same child.
Pneumococcal serotype 6A, 18B, 19A or 23A.
Among 9 detected S. aureus, 1 was mixed with Pseudomonas aeruginosa (thus, S. aureus should be considered as contaminant), while the remaining 8 with S. aureus as only pathogen were 50% from middle-ear fluid and 50% from spontaneous drainage.
%, percentage of episodes in the specified category; N, number of children; AOM, acute otitis media; C-AOM, clinically-confirmed AOM; B-AOM, bacteriologically-confirmed AOM; NTHi, non-typeable Haemophilus influenzae; intent-to-treat analysis, follow-up starting at the time of first vaccination; per-protocol analysis, follow-up starting 2 weeks post-dose 3.