Effect of Prevnar 13 on Ear Infections in Children

Otitis Media Clinical Trial

Official title:

"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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199016
• Other study ID #: 6096A1-4010
• Secondary ID: B1851018
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2010
• Last updated: April 26, 2016
• Start date: September 2010
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 30 Months

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

Procedure:
• Tympanocentesis
To be performed as needed on children presenting with acute otitis media
• Nose/throat swab
To be performed at every study visit

Biological:
• Observational
Observational Study Only

Locations

Country	Name	City	State
United States	Penfield Pediatrics	Penfield	New York
United States	Legacy Pediatrics	Rochester	New York
United States	Lewis Pediatrics	Rochester	New York
United States	Long Pond Pediatrics	Rochester	New York
United States	Pathway Pediatrics	Rochester	New York
United States	Sunrise Pediatrics	Rochester	New York
United States	Westfall Pediatrics	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Streptococcus Pneumoniae serotypes 1, 3, 5, 6A, 7F, and 19A isolated from middle ear fluid from children with acute otitis media.		5 years	No
Secondary	Streptococcus Pneumoniae serotypes 1, 3, 5, 6A, 7F, and 19A isolated the respiratory tract of children enrolled in this study.		5 years	No
Secondary	Streptococcus Pneumoniae serotypes not included in Prevnar 13 and other bacterial pathogens isolated from the middle ear fluid from children with acute otitis media.		5 years	No
Secondary	Streptococcus Pneumoniae serotypes not included in Prevnar 13 and other bacterial pathogens isolated from the respiratory tract of children enrolled in this study.		5 years	No

External Links

•   To obtain contact information for a study center near you, click here.