Pneumococcal Conjugate Vaccines and Otitis Media: An Appraisal of the Clinical Trials

Table 6

Vaccine efficacy and vaccine-attributable reduction values in the PCV clinical trials with otitis media as an endpoint [2, 4, 9, 12].

PCV7-CRM/FinOM [2]	Otitis media episodes		Bacteria*	Sp	Vaccine serotype
Vaccine efficacy	7%		—	34%	57%
Vaccine-attributable reduction^†	12 per 100		17 per 100	18 per 100	18 per 100
PCV7-OMPC/FinOM [9]	Otitis media episodes		Bacteria*	Sp	Vaccine serotype
Vaccine efficacy	−1%		—	25%	56%
Vaccine-attributable reduction^†	—		1 per 100	12 per 100	17 per 100
PCV7-CRM/Native American Trial [12]	Otitis media episodes		Bacteria*	Sp	Vaccine serotype
Vaccine efficacy	−0.1%		—	—	64%
Vaccine-attributable reduction^†	7 per 100		—	—	1 per 100
PCV11-PD/POET [4]	Outpatient visit episodes	Specialist referral episodes	Bacteria*	Sp	Vaccine serotype
Vaccine efficacy	—	32%	42%	52%	58%
Vaccine-attributable reduction^†	—	7 per 100	5 per 100	4 per 100	3 per 100

*Culture-confirmed S. pneumoniae, H. influenzae, M. catarrhalis, or any combination of these.
^†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 (see Table 5 for calculations).
Dash line indicates not reported.
Bacteria: bacteria in MEF isolates; Sp: pneumococcus in MEF isolates; vaccine serotype: vaccine-serotype pneumococcus in MEF isolates.