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

Table 3

Case split (control group  : pneumococcal vaccine group) for S. pneumoniae serotypes in the PCV clinical trials with otitis media as an endpoint [2, 4, 9, 12].

	Case split (control vaccine group  : pneumococcal vaccine group)
	FinOM [2]	FinOM [9]	Native American Trial [12]*	POET [4]
Study vaccine	PCV7-CRM	PCV7-OMPC	PCV7-CRM	PCV11-PD
Serotype
1	—	—	—	1 : 1
3	13 : 13	13 : 11	—	17 : 20
4	4 : 2	4 : 1	2 : 0	3 : 0
5	—	—	—	0 : 0
6B	56 : 9	56 : 12	0 : 0	24 : 3
7F	—	—	—	1 : 0
9V	11 : 5	11 : 2	0 : 0	8 : 3
14	26 : 8	26 : 11	1 : 0	22 : 1
18C	17 : 7	17 : 8	2 : 0	5 : 3
19F	58 : 43	58 : 37	3 : 3	43 : 24
23F	82 : 33	82 : 40	0 : 0	18 : 5

*Data obtained from 23 isolates collected for serotyping (11 PCV7 serotypes and 12 non-PCV7 serotypes) from 51 spontaneously draining otitis media episodes that grew S. pneumoniae; only the PCV7 serotype results are available.
For PCV7-CRM/NCKP, there were 16 cases of spontaneously draining ruptured tympanic membranes with culture of a vaccine-serotype pneumococcus in the fully vaccinated group (i.e., child <16 months of age who received three or more doses of vaccine, and child ≥16 months old who had received four doses of vaccine), 12 from children in the control group, and 4 from children in the PCV7-CRM group children. Four cases in fully PCV7-CRM-vaccinated children were serotype 19F; distribution of vaccine-serotype isolates in the control group was not reported [3, 15].
Dash line indicates not reported.