• Infectious Disease Clinical Trials
• Viral Infections
• Vaccinations
• Otitis Media

Acute otitis media (AOM) is a common medical condition with high incidence in children <5 years of age. [Monasta L et al. PLoS One 2012]. The incidence in Europe is ∼299 cases/1000 person-years in children under the age of 2 years [Liese J et al. ESPID 2011 Abstract 366]. Accurate diagnosis is difficult and may partially explain differences in incidence rates in different studies and countries [Toll EC, Nunez DA. J Laryngol Otol 2012]. Streptococcus pneumoniae, nontypeable Haemophilus influenzae (NTHi), and to a lesser extent Moraxella catarrhalis and Streptococcus pyogenes are the bacterial pathogens mainly responsible for AOM [Leibovitz E et al. Pediatr Infect Dis J 2004]. A trial with the 11-valent predecessor protein D conjugate vaccine demonstrated efficacy against AOM episodes caused by S. pneumoniae and NTHi [Prymula R et al. Lancet 2006].

Timo Vesikari, MD, University of Tampere, Tampere, Finland, presented preliminary data showing a trend toward positive vaccine effectiveness against AOM episodes for 10-valent pneumococcal nontypeable H. influenzae protein D conjugate vaccine (PHiD-CV) in infants.

This was a Phase 3/4, cluster-randomized, double-blind controlled study in Finland [NCT00839254] nested within a large invasive pneumococcal disease effectiveness study [NCT00861380; Palmu A. ESPID 2012 Abstract 1340]. Infants <7 months of age were randomized to receive 1 of 2 dose schedules of PHiD-CV (1 dose at age 3, 4, and 6 months or 1 dose at age 3 months and a second dose at 5 months; both groups received a booster dose at ∼12 months) or a control vaccine (hepatitis B) using the same schedules. The study participants were followed for 18 months. AOM surveillance was based on parental reporting of physician diagnosed AOM using an AOM questionnaire. AOM was diagnosed according to the 2004 Finnish national consensus guidelines (abnormal tympanic membrane+presence of middle ear fluid+sign(s) of acute infection). Vaccine effectiveness was calculated as 1 minus rate ratio with 95% CI for subjects reporting ≥1 AOM.

The total vaccinated cohort for effectiveness comprised 4117 infants allocated into 50 clusters with 4019 infants included in the per protocol cohort. Participants were mean age 2.3 months at first dose, about 50% female, and almost exclusively of white European heritage.

At least 1 AOM was reported in 63% of subjects in the PHiD-CV group and 67% in the control group. Both dose schedules reduced the number of reported cases of AOM; however the results were not statistically significant (Table 1). The results showed a trend toward positive vaccine effectiveness as shown by a reduction in number of subjects reporting ≥1 AOM following PHiD-CV administration. The trend for effectiveness against AOM was stronger using a 3 plus 1 vaccination schedule compared with a 2 plus 1 vaccination schedule. Vaccine effectiveness was similar for OM cases treated with antibiotics (97% of cases).

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