Effect of Prevnar 13 on Ear Infections in Children

"a Phase 4, Postmarketing Study Evaluating The Impact Of Prevnar 13 (Trademark)(13-valent Pneumococcal Conjugate Vaccine; 13vpnc) In Reducing Acute Otitis Media And Nasopharyngeal Colonization Caused By Streptococcus Pneumoniae In Healthy Children

Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar. It is expected that the effectiveness of Prevnar 13 against ear infections in children will be similar to that observed following Prevnar. Pfizer has committed to conduct a postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.

Infants who have completed the Prevnar 13 infant vaccination series who provide consent and fit the study inclusion criteria to participate in the study will be recruited.

Inclusion Criteria:

• Subject has received full (3-dose) infant series of Prevnar 13

Exclusion Criteria:

• Prior vaccination with any 7vPnC.
• Prior vaccination with 23-valent pneumococcal polysaccharide vaccine (23vPS).
• Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.