Impact of Prevnar 13 on Ear Infections in Children

Pfizer

Status: Completed

Conditions: Acute Otitis Media; Mastoiditis

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01272999

6096A1-4024

B1851040 (Other Identifier)

2014-001174-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 391 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Case eligibility should be based on microbiologic data and should be reviewed and documented by an appropriately qualified member of the investigator's study team before cases are included in the study database.
• S pneumoniae identified from middle ear fluid or mastoiditis sample.
• Specimen obtained from children aged up to 18 years.

Exclusion criteria

• As this is an observational, laboratory based database study, there are no exclusion criteria

Trial design

391 participants in 1 patient group

1

Description:

Otitis media cases

Treatment:

Other: No intervention