CompletedNot Applicable

Effect of Prevnar 13 on Ear Infections in Children

United States239 participantsStarted 2010-09

Plain-language summary

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.

Who can participate

Age range6 Months – 30 Months

SexALL

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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.

What they're measuring

Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)

Timeframe: Baseline up to Month 36

Trial details

NCT IDNCT01199016

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-01

Results submitted2017-01-10

View on ClinicalTrials.gov More Otitis Media trials