Effect of Prevnar 13 on Ear Infections in Children

Pfizer

Status: Completed

Conditions: Otitis Media

Treatments: Procedure: Tympanocentesis; Procedure: Nose/throat swab; Biological: Observational

Study type: Observational

Funder types: Industry

Identifiers

NCT01199016

B1851018 (Other Identifier)

6096A1-4010

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.

Full description

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.

Enrollment: 239 patients

Sex: All

Ages: 6 to 30 months old

Volunteers: No Healthy Volunteers

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.

Trial design

239 participants in 1 patient group

1

Treatment:

Procedure: Tympanocentesis

Biological: Observational

Procedure: Nose/throat swab