Table 3.
Meningitis cases.
| Meningitis cases based on clinical diagnosis by treating physician, n | ||||||
|---|---|---|---|---|---|---|
| 5–17 months age category (children) | 6–12 weeks age category (infants) | |||||
| Before dose 4 (M0–M20) | ||||||
| R3R | R3C | C3C | R3R | R3C | C3C | |
| N = 2976 | N = 2972 | N = 2974 | N = 2180 | N = 2178 | N = 2179 | |
| Meningitis (no pathogen identified) | 4 | 5 | 1 | 2 | 2 | 2 |
| Meningitis haemophilus | 1 | 0 | 0 | 0 | 0 | 0 |
| Meningitis meningococcal | 3 | 1 | 0 | 0 | 0 | 0 |
| Meningitis pneumococcal | 0 | 1 | 0 | 1 | 2 | 1 |
| Meningitis tuberculous | 0 | 0 | 0 | 0 | 0 | 0 |
| Meningitis viral | 1 | 0 | 0 | 0 | 0 | 0 |
| Meningitis salmonella | 0 | 0 | 0 | 2 | 1 | 0 |
| Meningitis total | 9 | 7 | 1 | 5 | 5 | 3 |
| Post-dose 4 (M21–SE) | ||||||
| R3R | R3C | C3C | R3R | R3C | C3C | |
| N = 2681 | N = 2719 | N = 2702 | N = 1996 | N = 1996 | N = 1976 | |
| Meningitis (no pathogen identified) | 1a | 0 | 0 | 0 | 1 | 1 |
| Meningitis haemophilus | 0 | 2 | 0 | 0 | 1 | 1 |
| Meningitis meningococcal | 0 | 1 | 0 | 0 | 0 | 0 |
| Meningitis pneumococcal | 0 | 0 | 0 | 0 | 0 | 1 |
| Meningitis tuberculous | 1 | 0 | 0 | 0 | 0 | 0 |
| Meningitis viral | 0 | 0 | 0 | 0 | 0 | 0 |
| Meningitis salmonella | 0 | 0 | 0 | 0 | 0 | 0 |
| Meningitis total | 2 | 3 | 0 | 0 | 2 | 3 |
| Relative risk for meningitis | ||||||
| 5–17 months age category (children) | 6–12 weeks age category (infants) | |||||
| Before dose 4 (M0–M20) | R3R+R3C vs C3C: | R3R+R3C vs C3C: | ||||
| 8.0 (95% CI: 1.1–60.3)b | 1.5 (95% CI: 0.4–5.6)b | |||||
| Entire study (M0–SE) | R3R vs C3C: 11.0 (95% CI: 1.4–85.1) | R3R vs C3C: 0.8 (95% CI: 0.3–2.7) | ||||
| R3C vs C3C: 10.0 (95% CI: 1.3–78.1) | R3C vs C3C: 1.2 (95% CI: 0.4–3.5) | |||||
| Meningitis and other central nervous system infections assessed by external experts, n | ||||||
| 5–17 months age category (children) | 6–12 weeks age category (infants) | |||||
| Before dose 4 (M0–M20) | ||||||
| R3R | R3C | C3C | R3R | R3C | C3C | |
| Confirmed meningitis | 5 | 4 | 0 | 3 | 4 | 1 |
| No meningitis | 3 | 2 | 2 | 3 | 2 | 3 |
| Undetermined | 4 | 2 | 3 | 2 | 0 | 0 |
| Post-dose 4 (M21–SE) | ||||||
| R3R | R3C | C3C | R3R | R3C | C3C | |
| Confirmed meningitis | 1 | 2 | 0 | 0 | 1 | 2 |
| No meningitis | 1 | 2 | 0 | 0 | 0 | 1 |
| Undetermined | 1 | 0 | 0 | 0 | 1 | 0 |
R3R, group receiving 4 doses of RTS,S/AS01; R3C, group receiving 3 doses of RTS,S/AS01 plus 1 dose of control vaccine; C3C, group receiving 4 doses of control vaccine; N, total number of children/infants per group; n, number of cases within the specified category; CI, confidence interval; M, month; SE, study end.
a This case occurred more than 20 months after dose 1, however, dose 4 was not given.
b RTS,S Clinical Trials Partnership PLoS Med 2014; 11: e1001685.
Confirmed meningitis, if the clinical pictures and the lab results were consistent with diagnosis of meningitis; undetermined, if the clinical pictures and/or the lab results were not consistent with diagnosis of meningitis and not consistent with another diagnosis, or were missing; no meningitis, if the clinical pictures and the lab results were consistent with another diagnosis.