Pneumococcal Conjugate Vaccines and Otitis Media: An Appraisal of the Clinical Trials
Table 5
Vaccine-attributable reduction values based on otitis media episodes and MEF isolates (bacteria, pneumococcus, or vaccine-serotype pneumococcus) from the PCV clinical trials with otitis media as an endpoint (PP groups) [2, 4, 9, 12].
Otitis media endpoint
No. of cases (no. vaccinated)
Difference*
Vaccine-attributable reduction†
Vaccine group
Control group
Otitis media episodes
PCV7-CRM/FinOM
1251 (786)
1345 (794)
−94
12
PCV7-OMPC/FinOM
1364 (805)
1345 (794)
+19
NA
PCV7-CRM/Native American
785 (424)
816 (432)
−31
7
PCV11-PD/POET
333 (2455)
499 (2452)
−166
7
Bacteria in MEF isolates‡
PCV7-CRM/FinOM
965 (786)
1082 (794)
−117
15
PCV7-OMPC/FinOM
1073 (805)
1082 (794)
−9
1
PCV7-CRM/Native American
—
—
—
—
PCV11-PD/POET
178 (2455)
306 (2452)
−128
5
Pneumococcus in MEF isolates
PCV7-CRM/FinOM
271 (786)
414 (794)
−143
18
PCV7-OMPC/FinOM
314 (805)
414 (794)
−100
12
PCV7-CRM/Native American
—
—
—
—
PCV11-PD/POET
92 (2455)
189 (2452)
−97
4
Vaccine-serotype pneumococcus in MEF isolates
PCV7-CRM/FinOM
107 (786)
250 (794)
−143
18
PCV7-OMPC/FinOM
110 (805)
250 (794)
−140
17
PCV7-CRM/Native American
3 (424)
8 (432)
−5
1
PCV11-PD/POET
60 (2455)
141 (2452)
−81
3
*Vaccine group minus control group. †Vaccine-attributable reduction: no. of cases prevented per 100 children vaccinated, which is the difference (vaccine group minus control group) divided by the no. vaccinated, then normalized per 100 children vaccinated. ‡S. pneumoniae, H. influenzae, and M. catarrhalis, or any combination of these. Dash line indicates not reported. NA: not applicable. PP: per-protocol.
