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

Table 4

Vaccine efficacy values in the long-term follow-up of PCV clinical trials with otitis media as an endpoint [3, 13]. Adapted with permission from Fletcher and Fritzell, 2007 Elsevier Ltd. All rights reserved [7].

Follow-up clinical trials
		NCKP [3]	FinOM [13]
Study vaccine		PCV7-CRM	PCV7-CRM
Period		1998–1999	1999–2001
No. of children		27,754	756
Age		Until aged 3.5 years	Until aged 4–5 years
Clinical endpoints*: vaccine efficacy, % (95% CI)
Otitis media visits (NCKP) or episodes (FinOM)	PP	8 (5–11)	8 (−2 to 16)
	ITT	7 (5–9)	—
Recurrent otitis media**
3/4		10 (7–13)	18 (1–32)
5/6		—	50 (15–71)^†
≥10^‡		26 (12–38)	—
All tympanostomy-tube placements		23 (−10 to 46)	39 (4–61)^†,§
			44 (19–62)^†,¶
Rate of AOM-related ambulatory visits		8 (5–10)	—
Rate of antibiotic prescriptions for AOM		6 (4–7)	—

*See Table 1 for primary otitis media endpoint, otitis media definition, myringotomy criteria, and source of MEF in each study.
**Number of episodes in 6 months/number of episodes in 1 year.
^†In children diagnosed with “chronic otitis media with effusion.”
^‡Efficacy against 10 or more episodes within 6 months.
^§ Primary analysis set (see Section 3.5.2. FinOM Vaccine Trial).
^¶ Secondary analysis set (see Section 3.5.2. FinOM Vaccine Trial).
Reported values are rounded to whole numbers; dash line indicates not reported.
CI: confidence interval; ITT: intent to treat; PP: per-protocol.