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
Verified date | April 2016 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
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. |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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 |
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