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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


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
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